louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01133080: Minocycline as an Adjunctive Therapy for Schizophrenia: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
First posted: 2010-05-28
Enrollment: 50
Sex: ALL
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: Double - Blind, Randomized, single centered study. The purpose of this study is to assess the feasibility of minocycline vs. placebo, added to atypical antipsychotic medications, for positive symptoms in adults suffering from schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Men and women 20-65 years of age.
* Primary DSM-IV diagnosis of Schizophrenia based on SCID for schizophrenia and confirmed by two senior psychiatrists.
* Patients who scored "moderate" (4) or higher on at least three of seven positive items in PANSS
* Initiated on treatment with atypical anti-psychotic medication.
* Capable and willing to provide informed consent
* Able to adhere to the treatment schedule
* Able to read, hear, write and speak the local language.
* Has signed a written informed consent to participate in the study

Exclusion Criteria:

* Patients with acute, unstable, significant, or untreated medical illness besides schizophrenia including alcohol and drug dependence, or depression.
* Current suicidal ideation or history of a suicide attempt in the past 3 years
* Known or suspected pregnancy or women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse. or women who are breastfeeding
* Subjects who were taking a known contraindication to minocycline treatment.
* Subjects who had received treatment with minocycline or β-lactam antibiotics in the preceding half year before study entry.
* Subjects who were under compulsory hospitalization.

Primary outcomes:
measure: Positive symptoms
timeFrame: from baseline to the end of the study (day 56)
Secondary outcomes:
Other outcomes:
Locations:
city: Hod Hasharon
country: Israel
facility: Shalvata Mental Health Center
city: Hod HAsharon
country: Israel
facility: shalvata MHC
Study officials:
affiliation: Shalvata MHC
name: Yechiel Levkovitz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03908580: MEDITOXIN® Treatment in Subjects With Post-Stroke Upper Limb Spasticity
Official title: A Prospective, Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Treatment of Post Stroke Upper Limb Spasticity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spasticity, Muscle
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2019-04-09
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is "A Prospective, Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Treatment of Post Stroke Upper Limb Spasticity".


Eligibility criteria: Inclusion Criteria:

1. Male or female over 20 years.
2. Subjects that was diagnosed with stroke at least 1 month before participating in the clinical trial.
3. Subjects with MAS score of ≥2 for local muscle spasticity of wrist flexor.

Exclusion Criteria:

1. Subjects with generalized neuromuscular junction disorder (ex: myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, etc.).
2. Subjects with fixed joint, muscle contracture, or atrophy in the treatment area.
3. Subjects with botulinum toxin treatment within 3 months before administration of the investigational product.
4. Known immunization or hypersensitivity to any botulinum toxin preparations.
5. Subjects who have recieved the following treatments within 4 weeks from screening: Muscle relaxants, Benzodiazepines, Aminoglycosides, Other antibiotics, Anticholinergics

Primary outcomes:
measure: Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in muscle tone determined by MAS (Modified Ashworth Scale) of elbow flexor and finger flexor
timeFrame: 4 weeks, 16 weeks, and 4 weeks after re-visit
measure: Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor
timeFrame: 16 weeks, and 4 weeks after re-visit
measure: The effective rate of wrist flexor, elbow flexor, and finger flexor
timeFrame: 4 weeks, 16 weeks, and 4 weeks after re-visit
measure: Change in DAS (Disability Assessment Scale) score
timeFrame: 4 weeks, 16 weeks, and 4 weeks after re-visit
measure: Change in QOL (SF-36v2; Quality of Life) score
timeFrame: 4 weeks, 16 weeks, and 4 weeks after re-visit
measure: Subject's or caregiver's global assessment
timeFrame: 4 weeks, 16 weeks, and 4 weeks after re-visit
measure: Number of participants with Adverse Events (AEs) to assess safety of investigational product.
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00975780: A Trial to Reduce Pneumonia in Nursing Home Residents
Official title: A Randomized Controlled Trial to Reduce Pneumonia in Nursing Home Residents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia
Lower Respiratory Tract Infection
Keywords: Pneumonia
Lower respiratory tract infection
Lower respiratory tract infection other than pneumonia
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2009-09-11
Enrollment: 834
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the effectiveness of an enhanced oral hygiene protocol in preventing pneumonia among nursing home residents.


Eligibility criteria: Inclusion Criteria:

* long term care resident of nursing home
* residents age \>65
* residents of nursing home for at least one month
* residents having at least one of two modifiable risk factors for pneumonia (i.e., impaired oral hygiene, swallowing difficulty)

Exclusion Criteria:

* residents housed in nursing home for short term rehabilitation
* residents who receive nourishment by tube feeding
* residents who have a life expectancy \< 3 months
* residents who have been diagnosed with pneumonia within the previous 6 weeks
* residents who are currently using oral chlorhexidine
* residents who have previously been enrolled in the study
* residents, or their designated proxies, who are unwilling to give informed consent
* residents who have tracheostomy
* residents who are non-english speaking
* residents who the administrator leadership of the home felt were not appropriate for the study

Primary outcomes:
measure: Pneumonia
timeFrame: 2.5 years
Secondary outcomes:
measure: Lower Respiratory Tract Infection Other Than Pneumonia
timeFrame: 2.5 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Vincent J Quagliarello, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Mary Tinetti, MD
role: STUDY_DIRECTOR
affiliation: Yale University
name: Manisha Juthani-Mehta, MD
role: STUDY_DIRECTOR
affiliation: Yale University
name: Peter Peduzzi, PhD
role: STUDY_DIRECTOR
affiliation: Yale University
name: Dorothy Baker, PhD
role: STUDY_DIRECTOR
References:
citation: Juthani-Mehta M, Van Ness PH, McGloin J, Argraves S, Chen S, Charpentier P, Miller L, Williams K, Wall D, Baker D, Tinetti M, Peduzzi P, Quagliarello VJ. A cluster-randomized controlled trial of a multicomponent intervention protocol for pneumonia prevention among nursing home elders. Clin Infect Dis. 2015 Mar 15;60(6):849-57. doi: 10.1093/cid/ciu935. Epub 2014 Dec 16.
Clinical trial NCT02828280: NuMask Versus Traditional Mask Ventilation During Routine Care
Official title: A Comparison of Controlled Ventilation With the NuMask vs. Traditional Mask Ventilation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Apnea
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients selected will be undergoing elective surgery at the University of Utah

Brief summary: The direct objective of this study is to determine whether an experienced provider can more adequately and/or easily ventilate an anesthetized patient with the NuMask device as compared to traditional bag-valve-mask ventilation. These are approved masks, being used in the patients routine care. The researchers believe that mean tidal volumes obtained by experienced providers when manually ventilating anesthetized patients with the NuMask device will be larger than when using the traditional bag-valve-mask.


Eligibility criteria: Inclusion Criteria:

* 44 adults total
* ASA status I-III
* aged 18-64
* elective surgery at the University of Utah under general anesthesia
* Bearded, BMI \>35 or edentulous

Exclusion Criteria:

* ASA IV or higher
* Oropharyngeal or facial pathology
* Risk of aspiration (defined by need for rapid sequence intubation, uncontrolled gastroesophageal reflux disease)
* Known and/or documented difficulty placing an endotracheal tube in the past
* Limited neck extension or flexion
* Personal or familial history of malignant hyperthermia
* Known or predicted severe respiratory disease or compromise
* Pregnancy

Primary outcomes:
measure: Tidal Volume comparison
timeFrame: 2 minutes (one minute for NuMask, one minute for traditional mask)
Secondary outcomes:
measure: Ease of use
timeFrame: 2 minutes
Other outcomes:
Locations:
Study officials:
affiliation: University of Utah
name: Derek Sakata, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caplan RA, Posner KL, Ward RJ, Cheney FW. Adverse respiratory events in anesthesia: a closed claims analysis. Anesthesiology. 1990 May;72(5):828-33. doi: 10.1097/00000542-199005000-00010.
Clinical trial NCT02741180: Sparsity-based Magnetic Resonance Imaging of Cardiac Arrhythmias
Official title: Sparsity-based Magnetic Resonance Imaging of Cardiac Arrhythmias
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Cardiac Arrythmias
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 135
Sex: ALL
Minimum age (years): 10
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The primary purpose of this study is to improve the quality of Magnetic Resonance Imaging in patients with heart arrhythmia. Investigators will recruit 105 patients with arrhythmia and 30 control volunteers over 3 years and will use two arrhythmia-tolerant imaging methods for diagnosis.

Detailed description: In the proposed research, investigators will extend conventional cardiac magnetic resonance methods to enable the creation of high-quality cine CMR images in the presence of multiple kinds of arrhythmia. Two arrhythmia-tolerant imaging methods will be adopted, which are particularly useful in arrhythmia: 1) 3D imaging, which is useful for many purposes, including "road mapping" of electrophysiology (EP) procedures, and 2) late gadolinium enhancement (LGE), which is useful for delineating abnormal myocardium, including fibrotic regions that can serve as sources of arrhythmias.

Eligibility criteria: Inclusion Criteria for Arrhythmia Patients:

* Patients diagnosed with heart arrhythmia scheduled for routine clinical MRI examinations).
* Patients scheduled for routine clinical MRI examinations who do not have a specific known diagnosis of arrhythmia, but who may be found to have image degradation due to arrhythmia during the CMR examination.

Inclusion Criteria for Controls:

* No history of heart arrhythmia.

Exclusion Criteria for Patients and Controls:

* Hemodynamic instability.
* Contraindications for MRI examinations (e.g., pacemakers or ferromagnetic vascular clips).
* History of prior cardiovascular disease or significant risk factors:

  * Diabetes, hypertension, smoking, and hyperlipidemia, etc.

Primary outcomes:
measure: Paired-sample Wilcoxon signed rank test to evaluate measures on Likert scales
timeFrame: 3 Years
measure: Paired-sample t tests for quantitative measures of intensity of image artifacts
timeFrame: 3 Years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Leon Axel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00919880: Comparison of Neo-adjuvant Weekly Paclitaxel With or Without Carboplatin in Early Breast Cancer
Official title: A Phase II Randomized Clinical Trial of Neo-adjuvant Weekly Paclitaxel With or Without Carboplatin in Early Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2009-06-12
Enrollment: 148
Sex: FEMALE
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 purpose of this study is to determine whether neo-adjuvant weekly paclitaxel with carboplatin is better than paclitaxel alone in efficiency and safety in early breast cancer, and to explore whether ultrasound and magnetic resonance imaging can predict the efficiency of neo-adjuvant chemotherapy.


Eligibility criteria: Inclusion Criteria:

* female patients between 18 and 65 years old
* pathological diagnosed invasive breast cancer; medium and high risk primary breast cancer according to St. Gallen 2007
* able and willing to give consent to participate in the study

Exclusion Criteria:

* pregnant or lactating females
* previous treatment for breast cancer
* other tumor history
* instable complication (e.g., myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or uncontrolled infection
* allergy history to similar drugs
* concurrent disease or condition that would make the patient inappropriate for study participation
* resist to participate in the study

Primary outcomes:
measure: significant effect rate (the proportion of G4 and G5, graded by Miller & Payne Method); null effect rate (the proportion of G1 and G2)
timeFrame: within the first 14 days (plus or minus 3 days) after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital Breast Center
state: Beijing
Study officials:
affiliation: Beijing Cancer Hospital Breast Center
name: Tianfeng Wang, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT04445480: Popliteal Block for Lower Limb Angioplasty
Official title: The Benefit of Popliteal Sciatic Nerve Block for Lower Limb Angioplasty in Critical Limb Ischemia: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angioplasty
Anaesthesia and Analgesia
Keywords: popliteal block
chronic limb ischemia
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Endovascular revascularization is an effective procedure in treatment of chronic critical limb ischemia. The less invasive procedure in high risk patients produce the benefit to the patients. However, some of the patients cannot tolerate local anaesthesia. These patients need sedation or even general anaesthesia, which increase unnecessary risk to the patients. This study is conducted to evaluate the benefit of popliteal sciatic nerve block or popliteal block compare to sedation in critical limb patients undergoing angioplasty.


Eligibility criteria: Inclusion Criteria:

* Age more than 20 year-old with chronic ischemic limb pain
* Scheduled for peripheral angioplasty under monitor anaesthesia care
* Expected timing of procedure not more than 3 hours

Exclusion Criteria:

* Age less than 21
* Cannot cooperate with the staff
* Having pain in other areas or both legs
* Contraindicate for nerve block
* Allergy to local anesthetic drugs or sedative drugs

Primary outcomes:
measure: Incidence of general anaesthesia
timeFrame: Five hours
Secondary outcomes:
measure: Numerical pain rating scale during procedure
timeFrame: Five hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Anesthesiology department, Siriraj Hospital, Mahidol University
Study officials:
References:
Clinical trial NCT01575080: Performance Evaluation of Blood Glucose Monitoring System Using ISO Study Design
Official title: Performance Evaluation of the Contour TS BGMS Using ISO/DIS 15197:2011 Section 8 Study Design and Performance Criteria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2012-04-11
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if untrained subjects who have diabetes can operate the Blood Glucose Monitoring System (BGMS) and obtain acceptable glucose results.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of diabetes
* Be 18 years of age or older
* Be able to speak, read and understand English and understand the Informed Consent document.
* Be willing to complete study procedures

Exclusion Criteria:

* Pregnancy
* Infections or skin disorders at the puncture site (at the discretion of the site professional staff).
* Hemophilia, bleeding disorder, or clotting problems. Persons taking aspirin (81 mg or 325 mg) daily or Plavix® are not reason for exclusion.
* Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGM (at the discretion of the site professional staff).
* A condition, in the opinion of the Investigator, would put the subject at risk or influence the conduct of the study or interpretation of the results. The reason for exclusion will be documented by the professional staff.
* Previously participated in a blood glucose monitoring study using Contour TS system or use the Contour TS for personal use when monitoring blood glucose.
* Working for a competitive medical device company or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company
* Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors

Primary outcomes:
measure: Number of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method
timeFrame: 1 hour
Secondary outcomes:
measure: Number of Self-Test Alternative Site (Palm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method
timeFrame: 1 hour
measure: Number of Self-Test Alternative Site (Forearm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method
timeFrame: 1 hour
measure: Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements
timeFrame: 1 hour
Other outcomes:
Locations:
city: Mishawaka
country: United States
facility: Bayer HealthCare LLC, Diabetes Care
state: Indiana
Study officials:
affiliation: Ascensia Diabetes Care
name: David Simmons, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06698380: The Effect of Mirror Therapy on Upper Extremity Motor Function in Stroke Rehabilitation
Official title: The Effect of Mirror Therapy on Upper Extremity Motor Function in Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Chronic Stroke Patients
Hemiplegia
Keywords: storke
Hemiplegia
mirror therapy
upper extremity
motor function
Lead sponsor: University of Jazan
Sponsor class: OTHER_GOV
Collaborators: name: King Saud Medical City
First posted: 2024-11-21
Enrollment: 38
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to determine the effect of mirror therapy versus conventional physical therapy treatment in improving upper extremity impairments and motor function among chronic hemiplegic subjects.

Research Objectives:

1. To discover the effectiveness of conventional physical therapy treatment on improving upper limb motor function among chronic hemiplegic subjects.
2. To find out the effect of mirror therapy along with conventional physical therapy treatment on improving upper limb motor function among chronic hemiplegic subjects.
3. To find out the effectiveness of mirror therapy combined with conventional physical therapy treatment versus conventional physical therapy treatment alone on improving upper extremity motor function among chronic hemiplegic subjects.


Eligibility criteria: Inclusion Criteria:

* Duration of stroke more than six months
* Subjects of chronic stroke with left or right hemiplegia.
* Genders of male and female with age ranging between forty-five to sixty-five years.
* MMSE scores greater than 23 out of 30.
* Scored one or one plus on MAS on all muscles of the affected upper limb.
* Have normal visual perception.
* Able to follow oral commands.

Exclusion Criteria:

* Unable to follow visual and oral commands.
* Unilateral neglect.
* Cognitive impairments (MMSE scores less than 24 out of 30), or language deficits.
* Any other neurological disorders and recent surgeries.
* Previous exposure to MT.

Primary outcomes:
measure: Fugl-Meyer Assessment Upper Extremity (FMA-UE)
timeFrame: week 0 and week 6
measure: Wolf Motor Function Test (WMFT)
timeFrame: week 0 and week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud Medical City
Study officials:
References: