louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00497835: Study of Algorithm for Epilepsy Alert Device
Official title: Epilepsy Alert Device - Epilert Performance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Motor Seizures
Keywords: motor seizures
accelerometer
algorithm
detection
alert
Lead sponsor: Biolert
Sponsor class: INDUSTRY
First posted: 2007-07-09
Enrollment: 15
Sex: ALL
Minimum age (years): 1
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to Video-LTM Unit with motor seizures.

Brief summary: An accelerometer with transmitting ability is worn on the wrist. Data of movements during seizures will be analyzed to upgrade algorithm that will identify seizures.

Detailed description: Patients undergoing Video-EEG telemetry will wear movement sensor on their wrist. The sensor will transmit continuous data to a laptop. Seizures' data (tonic or clonic) will be analyzed and transformed into an algorithm (up-graded existing preliminary algorithm).

In the second phase the algorithm will need to identify seizure events within one minute of the onset.

Both specificity ("false positive") and sensitivity ("false negative) will be than calculated.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing Long Term Monitoring for motor seizures

Exclusion Criteria:

* Invasive recording
* Psychogenic seizures

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Swetlana Kiperwasser, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01327235: Endostar and/or Cisplatin for Treatment of Malignant Pleural Effusion or Ascites
Official title: A Randomized Controlled Multicenter Trial of Endostar and/or Cisplatin in Patients With Malignant Pleural Effusion or Ascites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Pleural Effusion
Malignant Ascites
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-04-01
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the efficacy of Endostar/cisplatin with cisplatin alone or Endostar alone in patients with malignant pleural effusion or ascites.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological diagnosis of thoracic or abdominal tumor
* At least medium amount of malignant pleural effusion or ascites
* ECOG Performance Status 0-2
* Life expectancy ≥ 2 months
* Adequate hematologic, cardiac, renal, and hepatic function
* No major surgery within 4 weeks prior to this study
* Written informed consent

Exclusion Criteria:

* Patients with central nervous system (CNS) metastases
* Evidence of bleeding diathesis, serious infection
* Evidence of myocardial infarction, unstable angina or cardiac insufficiency
* Presence of serious COPD and/or respiratory failure
* Allergic to study drug
* Pregnant or lactating women
* Participation in other clinical trials within 30 days prior to this study

Primary outcomes:
measure: Objective Response Rate
timeFrame: baseline to measured progressive disease, every three weeks
Secondary outcomes:
measure: Time to Progression
timeFrame: baseline to every three weeks until disease progression
measure: Quality of Life
timeFrame: baseline to every three weeks
measure: Incidence of Adverse Events
timeFrame: Up to 1 month after the last treatment
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The 81st Hospital of Chinese PLA
city: Qingdao
country: China
facility: The Affiliated Hospital of Medical College, QingDao University
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: The 81st Hospital of Chinese PLA
name: Shukui Qin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03370835: Tolerability of Metoprolol-Succinate-ER and Carvedilol in COPD
Official title: Randomized Open-Label Crossover Trial Comparing Tolerability of a Cardioselective Beta-Blocker (Metoprolol-Succinate-ER) and a Non-Cardioselective Beta-Blocker (Carvedilol) in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Asthma
Adverse Effect of Beta-adrenoreceptor Antagonists
Keywords: Beta-Blocker
Chronic Obstructive Pulmonary Disease
COPD
Cardioselective
Lead sponsor: VA Greater Los Angeles Healthcare System
Sponsor class: FED
Collaborators: name: AstraZeneca
First posted: 2017-12-12
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Use of beta-blockers has proven beneficial in patients with hypertension, heart failure, and in people who have suffered a heart attack. The use in patients who have Chronic Obstructive Pulmonary Disease (COPD) and reactive airway disease, however, has been limited due to possible side effects such as worsening of lung function or increasing airway spasms and asthma attacks. The purpose of this study is to find out if patients with COPD can tolerate being on a beta-blocker at doses recommended for the treatment of heart disease conditions. This study also seeks to find out if a selective beta-1 receptor beta-blocker is better than a non-selective beta-blocker in patients with mild to moderate COPD.


Eligibility criteria: Inclusion Criteria:

* 40 years of age or older
* Mild to moderate COPD as defined by the American Thoracic Society
* Current treatment with a beta-blocker for either hypertension, myocardial infarction, or congestive heart failure.

Exclusion Criteria:

* Recent (within 30 days) COPD exacerbation or requirement for oral steroid therapy within the last 6 months
* Any history of ventilator support requirement for COPD
* Patients with asthma or reactive airway disease (RAD) defined as obstructive lung disease with a \>15% improvement in FEV1 with beta-agonist therapy
* Relative or absolute contraindication to beta-blocker therapy
* Exposure to any investigational drugs within the previous 30 days
* Patients with any concurrent disease or condition, which in the judgment of the investigator would make the patient inappropriate for participation in the study were excluded from this study

Primary outcomes:
measure: Percent Change in FEV1
timeFrame: 0, 4, 8, 14, 18 weeks
Secondary outcomes:
measure: Mean dose
timeFrame: 0-4, 4-8, 10-14, 14-18 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA West Los Angeles Medical Center
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System
name: Freny V Mody, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05553535: Diagnostic of Rotator Cuff Calcific Tendinosis Using MRI With ZTE Sequence
Official title: Diagnostic of Rotator Cuff Calcific Tendinosis Using MRI With ZTE Sequence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cuff Rotator Tendinitis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients over 18 years old referred to our department for a suspicion of rotator cuff tendinosis

Brief summary: Conventional radiographs are still considered the reference for identifying rotator cuff calcific tendinosis.

MRI is widely performed for rotator cuff disorders evaluation but has a moderate accuracy in rotator cuff calcific tendinosis diagnosis and calcific deposits identification (sensitivity and specificity around 60%), even though it helps in determining acuity of the finding by adjacent soft tissue edema depiction and differential diagnosis identification (i.e. adhesive capsulitis, sub-acromial bursitis...).

Zero echo time (ZTE) MRI provides enhanced bone contrast by enabling the acquisition of signals from tissues exhibiting the shortest T2 values on a single sequence with a spatial resolution of 0.8-1.2 mm isotropic and can therefore provide images similar to those obtained with radiographs.

We hypothesize that ZTE images could also depict rotator cuff calcific tendinosis, but to our knowledge, no study compared this technique to radiographs and/or standard MRI.


Eligibility criteria: Inclusion Criteria:

* patient referred to the imaging department for a MRI scan in case of suspicion of rotator cuff tendinosis

Exclusion Criteria:

* incomplete data sets

Primary outcomes:
measure: calcific deposits presence
timeFrame: Retrospective review of all MRI scans, performed at a maximum of 1 year before the reading, during two reading sessions, with an interval of 15 days, in october and november 2022
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Norenberg D, Ebersberger HU, Walter T, Ockert B, Knobloch G, Diederichs G, Hamm B, Makowski MR. Diagnosis of Calcific Tendonitis of the Rotator Cuff by Using Susceptibility-weighted MR Imaging. Radiology. 2016 Feb;278(2):475-84. doi: 10.1148/radiol.2015150034. Epub 2015 Sep 3.
citation: Aydingoz U, Yildiz AE, Ergen FB. Zero Echo Time Musculoskeletal MRI: Technique, Optimization, Applications, and Pitfalls. Radiographics. 2022 Sep-Oct;42(5):1398-1414. doi: 10.1148/rg.220029. Epub 2022 Jul 29.
Clinical trial NCT02984735: Chewing Performance Level and Gross Motor Function in Children With Cerebral Palsy
Official title: Association Between Chewing Performance Level and Gross Motor Function in Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Chewing Problem
Gross Motor Development Delay
Keywords: chewing
cerebral palsy
chewing disorders
gross motor function
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 152
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children with a diagnosis of spastic CP aged 2 to 12 years who were referred due to chewing/swallowing problems by pediatric neurologists

Brief summary: The purpose of this study is to determine the association between gross motor function and chewing performance level in children with cerebral palsy (CP). A cross-sectional study was conducted in 152 children (ages 2-10y, 51.3% male) with a diagnosis of spastic CP. The Gross Motor Function Classification System (GMFCS) was used to determine gross motor function levels of children. Chewing performance level was determined by using the Karaduman Chewing Performance Scale (KCPS).

Detailed description: The purpose of this study is to determine the association between gross motor function and chewing performance level in children with cerebral palsy (CP). A cross-sectional study was conducted in 152 children (ages 2-10y, 51.3% male) with a diagnosis of spastic CP. The Gross Motor Function Classification System (GMFCS) was used to determine gross motor function levels of children. Chewing performance level was determined by using the Karaduman Chewing Performance Scale (KCPS).Children with a diagnosis of spastic CP aged 2 to 12 years who were referred due to chewing/swallowing problems by pediatric neurologists were included. The inclusion criteria were above the age of 24 months, and had complaints about chewing function. Children under the age of 24 months, requiring tube feeding or taking any oral nutritional supplements, and used any medicine and/or oral appliances that could affect the chewing performance, were excluded.

Eligibility criteria: Inclusion Criteria:

* Above the age of 24 months
* Having complaints about chewing function.

Exclusion Criteria:

* Under the age of 24 months
* Requiring tube feeding or taking any oral nutritional supplements
* Using any medicine and/or oral appliances

Primary outcomes:
measure: Chewing performance level
timeFrame: 10 minutes
Secondary outcomes:
measure: Gross motor function level
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacetttepe University
Study officials:
affiliation: Hacettepe University
name: SELEN SEREL ARSLAN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00113035: Screening Protocol to Evaluate Acid Alpha-Glucosidase (GAA) Activity and GAA Gene Mutations in Patients With Late Onset Pompe Disease
Official title: Screening Protocol to Evaluate Acid Alpha Glucosidase (GAA) Activity and GAA Gene Mutations in Patients With Late Onset Pompe Disease for Potential Inclusion in Future Clinical Studies With Myozyme (Alglucosidase Alfa)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pompe Disease
Keywords: Glycogen Storage Disease Type II
GSD-II
Pompe Disease
Pompe Disease (Late-Onset)
Glycogen Storage Disease Type II (GSD-II)
Acid Maltase Deficiency
Glycogenosis 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Pompe disease (also known as glycogen storage disease type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The primary objective of this study is to identify potential candidates for future clinical studies in Pompe disease.


Eligibility criteria: Inclusion Criteria:

* Must provide written informed consent prior to any study-related procedures being performed
* Clinical presentation consistent with late-onset Pompe disease, or a current clinical diagnosis of late-onset Pompe disease
* Must be greater than or equal to 8 years of age
* Must be able to ambulate (use of assistive devices, such as a walker, cane or crutches, is permitted)

Exclusion Criteria:

* Requires the use of invasive ventilatory support
* Requires the use of noninvasive ventilatory support while awake and in an upright position
* Use of any investigational product within 30 days prior to study enrollment
* Unwillingness to comply with protocol requirements
* Has clinically significant organic disease, unstable medical condition, serious or intercurrent illness
* Is pregnant or lactating
* Has participated in the Prospective Observational Study in Patients with Late-Onset Pompe Disease (AGLU02303, "LOPOS")

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Tower Hematology/Oncology Medical Group
state: California
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: St. Louis
country: United States
facility: Washington University Medical Center
state: Missouri
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05586035: Analysis of Factors and Treatment Related to Chronic Cough After Pulmonary Resection
Official title: Analysis of Factors and Treatment Related to Chronic Cough After Pulmonary Resection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Persistent Cough
Pneumonectomy
Lung Neoplasms
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: The People's Hospital of Gaozhou
name: Shenzhen People's Hospital
First posted: 2022-10-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients underwent pulmonary resection in Guangdong Provincial People's Hospital and Shenzhen People's Hospital were eligible for this study.

Brief summary: Surgical resection is the primary treatment for pulmonary tumors. Surgeons has been frequently concerned about effectiveness, safety, and minimal invasive techniques. However, persistent cough, one of the most common complications of lung surgery, has received insufficient attention. This study set out to investigate the risk factors and treatment related to persistent cough after pulmonary resection.


Eligibility criteria: Inclusion Criteria:

1. Patients who received pulmonary resection;
2. 18-to 85-year-old;
3. Pathologically diagnosed as NSCLC or benign tumor.

Exclusion Criteria:

1. Multiple malignancy in other parts of body;
2. Refuse to participate in this study;
3. Other situations evaluated by investigators not meet the enrollment.

Primary outcomes:
measure: Occurence rate of persistent cough after pulmonary resection
timeFrame: Persistent cough after pulmonary resection is monitored from the time of surgery, up to 12 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT00982735: An Observational Cohort Study to Evaluate the Safety and Efficacy of Micardis Tablets Taken Once Daily at 40 mg/Day and 80 mg/Day in Hypertensive Patients Under Real Life Conditions in Usual Clinical Practice
Official title: An Observational Cohort Study to Evaluate the Safety and Efficacy of Micardis Tablets Taken Once Daily at 40 mg/Day and 80 mg/Day in Hypertensive Patients Under Real Life Conditions in Usual Clinical Practice.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-09-23
Enrollment: 987
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Essential hypertensive patients

Brief summary: The "CONTROL" study is an out patient based prospective observational cohort study. The main aim of the study is to survey the safety and efficacy of Micardis 40 mg/day and 80 mg/day under real life conditions in usual clinical practice in essential hypertensive patients in the Kingdom of Saudi Arabia. The patients participating in the study will be surveyed for 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Male or female.
* Aged 20 to 80 years old.
* Adult essential hypertensive either newly diagnosed and untreated, or previously treated and uncontrolled patients; sitting blood pressure: systolic BP \> 140 mmHg but \< 180 mmHg, and/or diastolic BP \> 90 mmHg but \< 110 mmHg).
* Patients who are assessed to benefit from the intake of angiotensin II receptor blocker (ARB) monotherapy or as add-on medication.

Exclusion Criteria:

* Patients with contraindications to telmisartan use (as per the Micardis® Tablets package insert).
* Known hypersensitivity to the active ingredient or to any of the excipients of Micardis® Tablets.
* Any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications.
* Patients participating in any other protocol

Primary outcomes:
measure: Number of Patients Achieving Blood Pressure (BP) Control, Sitting Diastolic BP Over Systolic BP 90 Over 140 mm Hg and/or Reduction From Baseline in Sitting Systolic BP or Diastolic BP More Than 10 mm Hg.
timeFrame: 24 weeks
Secondary outcomes:
measure: Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion
timeFrame: 24 weeks
measure: Change From Baseline in Microalbuminuria at 24 Weeks
timeFrame: Baseline and 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT02310035: Observational Study on the Course of Plasma Glutamine Levels During Critical Illness
Official title: Observational Study on the Course of Plasma Glutamine Levels During Critial Illness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glutamine Levels
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2014-12-05
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who are admitted to the ICU after elective surgery and non-elective admissions

Brief summary: Blood sampled for standard evaluation will be used for determination of plasma glutamine by Bioprofile Flex Glutamine Sensor at ICU admission

Detailed description: All patients who are admitted to the ICU after elective surgery and non-elective admissions. In both groups a total of 80 patients will be included.

(In the trials we mentioned in the introduction 80, 174 and 66 patients were included. In the study performed by Oudemans-van Straaten a decent distribution between lower and higher levels of glutamine was achieved in 80 non-elective patients.) Exclusion criteria are patients younger then 18 years and patients who need total parenteral nutrition (TPN).

The patients will receive standard care during their treatment on the ICU. Blood sampled for standard evaluation will be used for determination of plasma glutamine by Bioprofile Flex Glutamine Sensor at ICU admission. Hereafter plasma glutamine will be measured daily, a plasma sample will be taken from a standard evaluation blood sample at 6.00 am during admission on the ICU.

Eligibility criteria: Inclusion Criteria:

* all patients admitted to the ICU

Exclusion Criteria:

* younger then 18 years and patients who need total parenteral nutrition

Primary outcomes:
measure: glutamine in serum
timeFrame: from admission up to 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medical Centre Leeuwarden
Study officials:
affiliation: Frisius Medisch Centrum
name: Matty Koopmans, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buter H, Bakker AJ, Kingma WP, Koopmans M, Boerma EC. Plasma glutamine levels in patients after non-elective or elective ICU admission: an observational study. BMC Anesthesiol. 2016 Mar 10;16:15. doi: 10.1186/s12871-016-0180-7.