louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01338688: The Change of the Tetanus Antibody Titer After Single Injection of Td and Simultaneous Injection of TIG With Td
Official title: the Change of the Tetanus Antibody Titer After Single Injection of Tetanus Vaccine and Simultaneous Injection of Tetanus Immunoglobulin With Tetanus Vaccine?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tetanus
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Boramae Hospital
First posted: 2011-04-19
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy adult over twenty

Brief summary: The investigators want to determine whether TIG influences the formation of tetanus antibody after simultaneous tetanus vaccination according to age and the time-interval of the last tetanus vaccination.

Detailed description: When an injured patient visits the ED, unnecessary injection of tetanus immunoglobulin (TIG) may cause side effects and also increase the medical expense.5 Further, the opportunity of assessing a rising tetanus antibody titer may be missed after simultaneous injection of tetanus-diphtheria vaccine (Td) and TIG. According to age, the elevation of the tetanus antibody titer after tetanus prophylaxis might be not equivalent because of different levels of basal immunity and the time-interval of the last tetanus vaccination. Therefore, we wanted to determine whether TIG influences the formation of tetanus antibody after simultaneous tetanus vaccination according to age and the time-interval of the last tetanus vaccination.

Eligibility criteria: Inclusion Criteria:

* healthy adult volunteers

Exclusion Criteria:

* immunocompromised
* febrile
* allergy to the vaccine constituents
* previous tetanus immunization within 5 years
* medical and non-medical employees

Primary outcomes:
measure: The change from baseline in tetanus antibody titer at 4weeks, 6 months and 12months
timeFrame: Baseline, 4 weeks, 6 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Boramae Hospital
name: JongHwan Shin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05839288: Pyrotinib Plus Trastuzumab and Chemotherapy in HER2+ Metastatic Breast Cancer Patients
Official title: Pyrotinib Plus Trastuzumab and Chemotherapy in Metastatic HER2-positive Breast Cancer Patients- a Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Pyrotinib
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 161
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with breast cancer (according to International Classification of Diseases-10, ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

Brief summary: To evaluate the patterns and treatment outcomes of pyrotinib plus trastuzumab and chemotherapy in the real world.


Eligibility criteria: Inclusion Criteria:

* woman, age \> 18 years old
* diagnosed with HER2 +Metastatic Breast Cancer
* received pyrotinib plus trastuzumab and chemotherapy for at least one cycle, starting from 2018.07-2022.09
* available medical history

Exclusion Criteria:

* medical history was incomplete

Primary outcomes:
measure: progression-free survival (PFS)
timeFrame: 6 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT04909788: Factors and Characteristics of Heart Rate Variability in Runners
Official title: Factors and Characteristics of Heart Rate Variability During Long Distance Running
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Rate Variability
Sports Accident
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Shenzhen Second People's Hospital
First posted: 2021-06-02
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults with regular exercise

Brief summary: The purpose of this study is to describe the variation characteristics and factors of the heart rate variability during long-distance running.

Detailed description: Heart rate variability is recognized as the indicator to measure the autonomic nerve activity. By monitoring the heart rate variability of runners during long-distance running, we could monitor the status of the runners' cardiovascular system and predict the exercise risk of runners during long-distance running.

Eligibility criteria: Inclusion Criteria:

People have below conditions could be included:

1. age is 18-60 years.
2. have normal ECG .
3. agree to participate in the study.

Exclusion Criteria:

People have below conditions will be excluded:

1. have known Congenital heart disease and rheumatic heart disease.
2. have known Hypertension and cerebrovascular disease.
3. have known Myocarditis and other heart diseases.
4. have known Coronary artery disease and severe arrhythmia.
5. have known Diabetes with high or low blood glucose.
6. have a cold within two weeks before the study.
7. have other diseases considered unsuitable for participants in this study.

   -

Primary outcomes:
measure: change of heart rate variability
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhou Qin
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: sheng wei, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hua W, Zhang LF, Wu YF, Liu XQ, Guo DS, Zhou HL, Gou ZP, Zhao LC, Niu HX, Chen KP, Mai JZ, Chu LN, Zhang S. Incidence of sudden cardiac death in China: analysis of 4 regional populations. J Am Coll Cardiol. 2009 Sep 15;54(12):1110-8. doi: 10.1016/j.jacc.2009.06.016. No abstract available.
citation: Iskandar EG, Thompson PD. Exercise-related sudden death due to an unusual coronary artery anomaly. Med Sci Sports Exerc. 2004 Feb;36(2):180-2. doi: 10.1249/01.MSS.0000113685.89906.04.
Clinical trial NCT02191488: ALA-induced PpIX Fluorescence During Brain Tumor Resection
Official title: Quantification of ALA-induced PpIX Fluorescence During Brain Tumor Resection
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Brain Tumors
Keywords: Fluorescence
Brain Tumors
Brain Metastases
Malignant Glioma
Brain Lesions
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2014-07-16
Enrollment: 540
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Removing a tumor from a patients brain is hard to do because, very often, brain tumors do not have boundaries that are easy for the patients surgeon to find. In many cases, the surgeon can't tell exactly where the tumor begins or ends. The surgeon usually can remove most of the patient's tumor by looking at the MRI images that were taken of the patient's brain before surgery. However, the surgeon does not have any good way to tell if the entire tumor has been removed or not. Removing the entire tumor is very important because leaving tumor behind may allow it to grow back which could decrease the chances of survival.


Eligibility criteria: Inclusion Criteria:

* Preoperative diagnosis of either presumed first-time low or high grade glioma, or recurrent glioma, or metastasis, or meningioma
* Tumor judged to be suitable for open cranial resection based on preoperative imaging studies.
* Patient or LAR able to provide written informed consent.
* No serious associated psychiatric illnesses.
* Age \> 21 years old.

Exclusion Criteria:

* Pregnant women or women who are breast feeding
* History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis.
* History of liver disease within the last 12 months.
* Elevated liver function levels greater than 2.5 times the normal limit from laboratory tests conducted within 30 days prior to surgery.
* Inability to comply with the photosensitivity precautions associated with the study.
* Plasma creatinine in excess of 180umol/L within 30 days prior to surgery

Primary outcomes:
measure: Comparison of intraoperative measurements of PpIX concentration to coregistered histopathology
timeFrame: Up to five years from the first surgery date
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: David W. Roberts, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roberts DW, Olson JD, Evans LT, Kolste KK, Kanick SC, Fan X, Bravo JJ, Wilson BC, Leblond F, Marois M, Paulsen KD. Red-light excitation of protoporphyrin IX fluorescence for subsurface tumor detection. J Neurosurg. 2018 Jun;128(6):1690-1697. doi: 10.3171/2017.1.JNS162061. Epub 2017 Aug 4.
Clinical trial NCT01614288: High Tibial Osteotomy (HTO) With or Without Arthroscopy of the Knee Joint
Official title: A Randomized Clinical Trial to Compare the Effectiveness of High Tibial Osteotomy (HTO) With or Without Arthroscopy of the Knee Joint on Quality of Life, Function, Pain and Swelling for Patients With Medical Compartment Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Medial Compartment Osteoarthritis of the Knee
Keywords: HTO
Arthroscopy
Quality-of-Life
Gait Analysis
Lead sponsor: University of Western Ontario, Canada
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants will be randomized to undergo a High Tibial Osteotomy (HTO) with or without a knee scope. Patients will be tested in the Gait Lab, will fill out quality-of-life questionnaires, and have a clinical evaluation done preoperative and at each follow-up visit.


Eligibility criteria: Inclusion Criteria:

* All patients booked for an HTO due to OA
* Grades II to IV severity of OA by radiographic evaluation (Kellgren \& Lawrence grade)
* OA of the knee primarily involving the medial compartment

Exclusion Criteria:

* Imaging evidence of significant knee joint pathology that would change the decision to do an HTO
* An arthroscopy of the knee within 2 years of planned surgery
* Active joint or systemic infection,
* Major medical illness that would preclude undergoing surgery,
* Patients who are unwilling or unable to be assessed according to study protocol for two years following surgery
* Major psychiatric illness, developmental handicap or inability to read and understand the English language

Primary outcomes:
measure: WOMAC
timeFrame: Preoperatively; 3, 6, 12, 18 and 24 months
Secondary outcomes:
measure: The Lower Extremity Functional Scale (LEFS)
timeFrame: Preoperatively; 3, 6, 12, 18 and 24 months
measure: Patient Diary to asses swelling, pain and frequency of analgesic and NSAID use.
timeFrame: Daily x 2 weeks post surgery; Weekly x 3 months
measure: SF-12
timeFrame: Preoperatively; 3, 6, 12, 18 and 24 months
measure: Gait Testing Procedures
timeFrame: 6, 12 and 24 months post-operatively
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
Study officials:
affiliation: The University of Western Ontario
name: Dianne Bryant, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05645588: Pranayama for Posttraumatic Stress Disorder
Official title: Pranayama for Outpatients With Posttraumatic Stress Disorder: a Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: Posttraumatic Stress Disorder
Pranayama
Yoga
Complimentary Therapies
Somatic Symptom Disorder
SSD
PTSD
Safety
Effectiveness
Randomized Controlled Trail
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effect of pranayama (yoga-breathing techniques) on post-traumatic symptom severity in patients with post-traumatic stress disorder undergoing standard, out-patient, trauma-focused psychotherapy. Therefore, short pranayama sessions of 5-10 minutes will be provided to the patients directly at the begin of each of psychotherapy unit, while the control group will receive standard, trauma-focused psychotherapy alone.


Eligibility criteria: Inclusion Criteria:

* Diagnosed PTSD according to ICD-10 F43.1
* PCL-5 Score of at least 33 points
* Undergoing outpatient standard trauma-focused psychotherapy (Cognitive Behavioral Therapy, Psychodynamic Psychotherapy, or Systemic Psychotherapy)

Exclusion Criteria:

* Pre-existing mental or somatic conditions that are unlikely to result in correct or safe performance of pranayama:

  1. Substance dependence current use (ICD-10 F10.X, F11.X).
  2. Dementia (ICD-10 F00-F03)
  3. Somatoform Disorder (ICD F45.X) of moderate or severe degree according to DSM-5 300.82: ≥ 2 reactions (cognitive, emotional, or behavioral) to somatic symptoms (≥ 2 criterion-B)
  4. Severe cardiovascular disease: presence of cardiac or vascular implants or grafts, e.g., pacemaker (ICD-10 Z95.X), condition after organ or tissue transplantation (ICD-10 Z94.X)
  5. Acute adverse events occurring during pranayama at baseline (including neck pain, subjective sensation of pressure in the lungs, anxiety / panic)
* Cancer diagnosis in the past 5 years (ICD-10 C00-C97, D37-48)
* Pregnancy / breastfeeding
* Regular pranayama practice in the last 12 months

Primary outcomes:
measure: Intensity of posttraumtic symptoms
timeFrame: week 10
Secondary outcomes:
measure: Health-related quality of life
timeFrame: week 10
measure: Anxiety
timeFrame: week 10
measure: Depression
timeFrame: week 10
measure: Breath Holding Duration
timeFrame: week 10
measure: Adverse Events
timeFrame: weeks 1,2,3,4,5,6,7,8,9,10
measure: Therapist Global Improvement
timeFrame: week 10
measure: Patient Global Improvement
timeFrame: week 10
Other outcomes:
measure: Treatment Expectation
timeFrame: week 0
measure: Interoceptive Awareness
timeFrame: weeks 0+10
measure: Social Readjustment after life events
timeFrame: weeks 0+10
measure: Compliance
timeFrame: weeks 0,1,2,3,4,5,6,7,8,9,10
measure: Medication
timeFrame: weeks 0+10
Locations:
Study officials:
References:
Clinical trial NCT00654888: Automated Lamellar Keratectomy in Symptomatic Patients With Bullous Keratopathy
Official title: Study of Automated Lamellar Keratectomy With a New Option in Treatment in Symptomatic Patients With Bullous Keratopathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Disease
Keywords: cataract extraction
surgery
corneal disease
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2008-04-09
Enrollment: 28
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To relieve pain in patients with symptomatic bullous keratopathy (BK) until keratoplasty and in patients without visual prediction.

The automated lamellar keratectomy represents a alternative in treatment of pain in symptomatic patients with BK.

Detailed description: Only patients with BK symptomatic (with pain) were submitted to automated lamellar keratectomy (ALK).

Complete ophthalmological examination including UCVA,BSVA, biomicroscopy, tonometry, esthesiometry, UBM pachymetry, impression cytology and pain questionnaire were performed in preoperative, postoperative of one, seven, 30, 90, 180 days and one year.

Eligibility criteria: Inclusion Criteria:

* Patient with bullous keratopathy symptomatic (with pain)

Exclusion Criteria:

* herpetic endotelial disorders

Primary outcomes:
measure: Pain questionnaire
timeFrame: preoperative and postoperative 1,7,30,90,180 days and one year
Secondary outcomes:
measure: biomicroscopy, esthesiometry, UBM pachymetry, impression cytology
timeFrame: preoperative, postoperative 1,7,30,90,180 days and one year
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Eliana D Gonçalves, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02229188: Games to Overcome Late Life Depression
Official title: Games to Overcome Late Life Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Depression; mood; cognitive training
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2014-09-01
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a pilot study divided into two phases. IN phase 1 (completed) participants will be randomized to receive 8 weeks of Problem Solving Therapy (PST) alone or 8 weeks of a cognitive training game called, Evolution (Evo) plus clinical management. In Phase 2 (now recruiting), participants will be randomized to Evo, PST, and a different cognitive training program called Words. Words is similar to Evo in that it is an adaptive training program and includes case management. IN both studies participants will be assessed for clinical and functional magnetic resonance imaging (fMRI) outcomes at baseline, 4 weeks and 8 weeks.

Detailed description: Evo is a computer game that targets parts of the brain (i.e. the cognitive control network) that we think may be associated with depressive symptoms. This study is exploratory and will inform future hypotheses the research team will test in subsequent research.

Eligibility criteria: Inclusion Criteria:

1. Between 60-80 years of age
2. Meets criteria for Major Depressive Disorder
3. Hamilton Depression Rating Scale (HDRS) of 20 or greater
4. Mini Mental State Exam score of 24 or greater
5. Can speak and read English
6. Able to physically participate in the research protocol (e.g.: is not suffering from a terminal or highly disabling illness)
7. Can participate in MRI scans
8. Able to provide written informed consent

Exclusion Criteria:

1. History of psychosis, mania, or currently using or abusing illicit drugs or alcohol
2. Diagnosis of dementia
3. Taking cognitive enhancers
4. Change in or newly began taking psychiatric medication within the last 6 months
5. Pacemaker
6. Metal in the body that cannot be removed
7. Color blind
8. Movement disorder that prevents participation -

Primary outcomes:
measure: Change in depression over time
timeFrame: weeks 0, 4, 8, 24
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Department of Psychiatry and Behavioral Sciences
state: Washington
Study officials:
affiliation: University of Washington
name: Patricia Arean, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anguera JA, Gunning FM, Arean PA. Improving late life depression and cognitive control through the use of therapeutic video game technology: A proof-of-concept randomized trial. Depress Anxiety. 2017 Jun;34(6):508-517. doi: 10.1002/da.22588. Epub 2017 Jan 3.
Clinical trial NCT00761488: Recommendations for Monitoring Clinical Experience Following Implantation of the AcrySof® Toric
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Cataract
Keywords: Visual acuity,
corneal and
refractive
cylinder
following
implantation of the
AcrySof® Toric
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-29
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To allow surgeons to obtain clinical experience on the postoperative uncorrected and best distance corrected visual acuities (UCVA and BDCVA) and corneal and refractive cylinder of the AcrySof Toric IOL.


Eligibility criteria: Inclusion Criteria:

* 40-80 years old; of any race and gender; diagnosed with bilateral cataracts; require cataract extraction followed by implantation of a posterior chamber IOL; patients have between 0.75 -2.5 D of astigmatism preoperatively as measured by K readings.

Exclusion Criteria:

* Females of child bearing potential;irregular corneal astigmatism;keratopathy/Keratectasia; cornea inflammation or edema;previous corneal reshaping,dystrophy or transplant;amblyopia;glaucoma;RPE/Macular changes;diabetic retinopathy.

Primary outcomes:
measure: Corneal astigmatism; IOL rotation
timeFrame: Before opertation; 1 day following implantation of each eye; 1, 3 months following lens implantation in the second eye.
Secondary outcomes:
measure: Uncorrected and best distance corrected visual acuities (UCVA and BDCVA)
timeFrame: Before opertation; 1 day following implantation of each eye; 1, 3 months following lens implantation in the second eye.
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center
state: Texas
Study officials:
References: