louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03165188: Long Term Follow-Up Study for Subjects Previously Treated With Algenpantucel-L (HyperAcute-Pancreas) Immunotherapy
Official title: Long Term Follow-Up Study for Subjects Previously Treated With Algenpantucel-L (HyperAcute-Pancreas) Immunotherapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pancreatic Cancer
Lead sponsor: Lumos Pharma
Sponsor class: INDUSTRY
First posted: 2017-05-24
Enrollment: 29
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: Research subjects who have received at least one dose of algenpantucel-L immunotherapy in clinical trials.

Brief summary: This protocol (NLG0705) provides a mechanism for the 15-year follow-up period that the FDA requires for all participants in gene transfer protocols and assures that adequate follow-up can be maintained for subjects who have received at least one dose of algenpantucel-L.


Eligibility criteria: Inclusion Criteria:

* Receipt of at least one dose of algenpantucel-L within the past 15 years
* Signed consent

Primary outcomes:
measure: Proportion of subjects with adverse events.
timeFrame: Up to 15 years
measure: Survival
timeFrame: Up to 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford University Cancer Center
state: California
city: Gainesville
country: United States
facility: UF Health Cancer Center
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Goshen
country: United States
facility: Indiana University Health Goshen Center for Cancer Care
state: Indiana
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: UT Health Cancer Center
state: Texas
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
References:
Clinical trial NCT00037388: Pediatrics:Chlamydia, Sickle Cell Anemia and Stroke Risk - Ancillary to STOP II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Disease
Anemia, Sickle Cell
Chlamydia Infections
Cerebrovascular Accident
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2002-05-17
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief summary: To establish a link among Chlamydia infection, sickle cell anemia, and stroke risk.

Detailed description: BACKGROUND:

Infection with Chlamydia pneumoniae (C. pneumoniae) is associated with an increased risk of cerebrovascular disease in the general population. Children with sickle cell anemia (SCA) are 200 times more likely to have cerebrovascular disease than normal children and are known to have an altered immune response to many infectious pathogens. C. pneumoniae is the leading infectious cause of acute chest syndrome which, interestingly, is a well- established risk factor for stroke in children with SCA. Preliminary data indicates that SCA patients with magnetic resonance imaging (MRI)-documented cerebral infarction are 12 times more likely to have C. pneumoniae infection than SCA patients with normal MRI scans. The investigators hypothesize that SCA patients have an abnormal immune response to C. pneumoniae that results in persistent infection which, in turn, triggers the development of cerebrovascular disease. Sickle cell anemia patients with an elevated velocity on transcranial doppler ultrasound (TCD) are known to be at high risk to develop stroke and an elevated TCD likely reflects underlying vascular disease. In addition, the Stroke Prevention in Sickle Cell Anemia Trial (STOP) demonstrated that almost 40 percent of children with an elevated TCD have evidence of cerebral infarction on MRI. Children with abnormal TCDs are, therefore, an appropriate population to investigate an association between cerebrovascular disease and C. pneumoniae infection.

The study is in response to an initiative on Ancillary Studies in Heart, Lung, and Blood Disease Trials released in June, 2000.

DESIGN NARRATIVE:

The study is ancillary to the STOP II clinical trial. The intent is: 1) To determine if C. pneumoniae infection is associated with cerebral infarction in children with SCA; 2) To characterize the immunological response to C. pneumoniae infection in patients with SCA. Establishing a link between C.pneumoniae infection and cerebral infarction will open the door to novel, less toxic approaches to the treatment and prevention of stroke in SCA, including antibiotics and vaccines.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UCSF Benioff Children's Hospital Oakland
name: Lori Styles
References:
Clinical trial NCT03813888: Effect of Arshvidya After School Program on Cognitive Processes in Elementary School Children
Official title: Effect of Arshvidya After School Program on Cognitive Processes in Elementary School Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Warwick Research Services
name: Arsha Vidya Study Centre, Tamilnadu, India
First posted: 2019-01-23
Enrollment: 70
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The impact of Arsha Vidya program on cognitive performance was examined in elementary school children. The study compares the effects of arsha vidya after school routine with usual after school routine in healthy 8-11 year-old Indian children.

The main objective of the study is to investigate the effect on cognitive function, behaviour and emotions.


Eligibility criteria: Inclusion Criteria:

* Be 8 - 11 years of age at the start of the intervention
* Healthy Children
* Not start new activity within the intervention period
* Parental conset
* Parents to allow and participate where needed in intervention

Exclusion Criteria:

* Serious chronic illnesses and diseases
* Diagnosed with any psychiatric illness
* Intake of medication that may affect study outcomes
* not able to continue for 12-weeks of participation

Primary outcomes:
measure: Cognitive function
timeFrame: Change from baseline to 12-week
Secondary outcomes:
measure: Behaviour
timeFrame: Change from Baseline to 12-weeks
measure: Attention
timeFrame: Change from baseline to 12-weeks
Other outcomes:
Locations:
city: Jaipur
country: India
facility: NMP Medical Research Institue
state: Rajasthan
Study officials:
affiliation: Warwick Research Services
name: Neha Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sarvatra International, Dubai
name: Puneet Sharma
role: STUDY_DIRECTOR
affiliation: Arsha Vidya Study Centre, India
name: Buddhatmananda Saraswati
role: STUDY_CHAIR
References:
Clinical trial NCT01375088: Assessing the Preventing and Therapeutic Effect of Propolis in Radiotherapy Induced Mucositis of Head and Neck Cancers
Official title: Phase I Assessing the Preventing and Therapeutic Effect of Propolis in Radiotherapy Induced Mucositis of Head and Neck Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Radiation-induced Mucositis of Oral Mucous Membranes
Keywords: propolis
mucositis
radiotherapy
cancer
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-06-17
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
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 propolis is effective in the treatment and prevention of radiotherapy induced oral mucositis.

Detailed description: Patients with head and neck malignancy with inclusion criteria randomly divide in 2 groups and take the intervention.

Eligibility criteria: Inclusion Criteria: - age \>15

* need of radiotherapy
* at least half of the mouth in the field of radiation
* dose 50 -70 Gy
* head \& neck malignancy

Exclusion Criteria:

* systemic disease
* FBS \> 150 WBC \> 3000
* history of radiotherapy
* need of chemotherapy
* systemic disease

Primary outcomes:
measure: NCI.CTC Scale
timeFrame: 9 month
Secondary outcomes:
measure: hyposalivation scale
timeFrame: 9 month
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad University of Medical Science
state: Khorasan Razavi
Study officials:
affiliation: oral medicine dep, dental school, mashhad university of medical science
name: arghavan tonkaboni, resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00901888: Interaction of Apelin and Angiotensin in the Human Forearm Circulation
Official title: Investigating the Interaction of Apelin and Angiotensin II Peripheral Resistance Vessels in Vivo in Man
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Disease
Vasodilation
Keywords: Renin Angiotensin System
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2009-05-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The apelin-APJ system is a relatively new discovery. It has generated interest in part due to it's apparent ability to counteract the renin-angiotensin system, which is frequently overactive in many cardiovascular disease.

Angiotensin has a powerful ability to cause blood vessels constrict and reduces their diameter. One of the actions of apelin is to cause blood vessels to relax and the investigators specifically wish test the hypothesis that apelin will cause blood vessels constricted by angiotensin II to relax.


Eligibility criteria: Inclusion Criteria:

* \> 18 years old

Exclusion Criteria:

* Lack of informed consent
* Age \< 18 years,
* Current involvement in other research studies,
* Systolic blood pressure \>190 mmHg or \<100 mmHg
* Malignant arrhythmias
* Renal or hepatic failure
* Haemodynamically significant aortic stenosis
* Severe or significant co morbidity
* Women of childbearing potential.
* Any regular medication
* Previous history of any cardiovascular disease

Primary outcomes:
measure: Change in apelin mediated forearm blood flow
timeFrame: 12 months
Secondary outcomes:
measure: Change in local and systemic plasma apelin concentration in response angiotensin II infusion
timeFrame: 12 months
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc
Study officials:
affiliation: University of Edinburgh
name: Gareth D Barnes, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barnes GD, Alam S, Carter G, Pedersen CM, Lee KM, Hubbard TJ, Veitch S, Jeong H, White A, Cruden NL, Huson L, Japp AG, Newby DE. Sustained cardiovascular actions of APJ agonism during renin-angiotensin system activation and in patients with heart failure. Circ Heart Fail. 2013 May;6(3):482-91. doi: 10.1161/CIRCHEARTFAILURE.111.000077. Epub 2013 Mar 21.
Clinical trial NCT04296188: Erector Spina Plane Block vs Serratus Anterior Plane Block for Postoperative Mastectomy Pain
Official title: Comparison of Erector Spina Plane Block and Serratus Anterior Plane Block in Patients Undergoing Mastectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mastectomy
Pain, Postoperative
Recovery Period, Anesthesia
Keywords: Pain Management
Quality of Healthcare
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 60
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 aim of this study is to compare the efficiency of serratus anterior plane block and erector spina plane block on analgesic consumption, postoperative pain and patient's satisfaction and recovery quality in patients undergoing mastectomy.

Detailed description: Mastectomy may cause severe postoperative pain. There are several analgesic methods for postoperative pain management. Serratus anterior plane (SAP) block is an interfascial plane block which is performed into the fascial plane of serratus anterior muscle. It provides effective analgesia in anterior, posterior and lateral dermatomes of thorax. There are several studies about its analgesic efficacy for mastectomy pain. The erector spina plane (ESP) block is another novel plan block which provides analgesia at multi-dermatomal area of the anterior, posterior, and lateral thoracic and abdominal walls. There are some studies about its effectiveness for postoperative mastectomy pain management. However, according to our best knowledge, there is no literature comparing the efficacy of ESP block and SAP block patients undergoing mastectomy.

Eligibility criteria: Inclusion Criteria:

* American society of score anesthesiologist I-II-III
* Elective modified radical mastectomy
* 18-65 years old

Exclusion Criteria:

* neurological disease
* coagulopathy disease or using anticoagulants
* non-cooperative
* allergic to one of the drugs used in the study
* recurrent breast cancer
* body mass index is above 35

Primary outcomes:
measure: Analgesic consumption
timeFrame: From at the end of surgery (at postoperative 0th hour) to postoperative 24th hours
Secondary outcomes:
measure: Postoperative pain intensity
timeFrame: At 0,2,4,6,12,24th hours after surgery
measure: Quality of recovery
timeFrame: At postoperative 24th hours
measure: The number of patients with perioperative side effects
timeFrame: From 30 minute before surgery to postoperative 24th hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05873088: Effects of Isometric Versus Isotonic Exercise in Female Patients With Osteoarthritis
Official title: Effects of Isometric Versus Isotonic Exercise in Female Patients With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 64
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: to find out the Effects of Isometric Versus Isotonic Exercise in Female Patients With Osteoarthritis


Eligibility criteria: Inclusion Criteria:

* Female patients with osteoarthritis Age group of 35 to 60

Exclusion Criteria:

* Patients admitted in ICU or HDU Patients with any mental illness

Primary outcomes:
measure: WOMAC Scale
timeFrame: 6 Months
measure: VAS score
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Chaudhary Muhammad Akram Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT00773188: A Feasibility Trial of Avastin (Bevacizumab) in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Patients With Locally Advanced Non-Squamous Non-Small Cell Lung Cancer.
Official title: A Single-arm, Open-label, Multicenter Feasibility Trial of Bevacizumab Given in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Locally Advanced Unresectable Non-squamous, Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-10-16
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the feasibility of use, safety and tolerability of Avastin(bevacizumab) in combination with chemoradiation therapy in patients with locally advanced unresectable non-squamous non-small cell lung cancer.An initial cohort of patients will receive Avastin 7.5mg/kg iv every 3 weeks, in combination with concurrent thoracic radiation for 6.6 weeks and chemotherapy (cisplatin 75 mg/m2 iv and vinorelbine 15mg/m2 iv administered according to a standard treatment protocol). If no dose-limiting toxicities are observed, a second cohort of patients will receive Avastin at a dose of 15mg/kg iv every 3 weeks, in combination with a similar treatment regimen to that of the first cohort. After 5 cycles of combination treatment, Avastin monotherapy will be administered for a further 4 cycles. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* patients \>=18 years with locoregional advanced unresectable non-squamous NSCLC;
* ECOG performance status of 0 or 1;
* no prior thoracic head and neck irradiation or surgical resection for current lung cancer.

Exclusion Criteria:

* mixed, non-small cell and small cell tumors;
* mixed adeno-squamous carcinomas with a predominant squamous component;
* evidence of tumor invasion or encasement of major vessels;
* history of grade \>=2 hemoptysis;
* presence of cavitations in lung lesions at baseline.

Primary outcomes:
measure: Safety: Adverse events; clinical laboratory parameters; physical exam including vital signs; performance status.
timeFrame: Throughout study
Secondary outcomes:
measure: Tumor response
timeFrame: Week 13 and Week 22
Other outcomes:
Locations:
city: Calgary
country: Canada
state: Alberta
city: Oshawa
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01562288: Studying Blood and DNA Samples From Patients With Breast Cancer Treated With Chemotherapy With or Without Trastuzumab
Official title: Adjuvant Chemotherapy Combined With Trastuzumab in the Randomized Phase III Trial N9831 Actively Immunizes Patients Against Tumor Antigens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: HER2-positive breast cancer
HER2-negative breast cancer
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-03-23
Enrollment: 1576
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled on NCCTG-N9831.

Brief summary: RATIONALE: Studying samples of blood and DNA in the laboratory from patients who received chemotherapy with or without trastuzumab may help doctors learn more about the effects of trastuzumab on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research trial studies blood and DNA samples from patients with breast cancer treated with chemotherapy with or without trastuzumab.

Detailed description: OBJECTIVES:

* To determine the role of trastuzumab in the generation of HER2-specific antibodies in breast cancer patients undergoing adjuvant combination therapy.
* To determine whether the improved disease-free period and overall survival of patients treated in the adjuvant setting with combination of chemotherapy and trastuzumab is dependent on the Fcγ receptor genotype of the patient.

OUTLINE: Previously collected serum and DNA samples are analyzed for HER2-specific antibodies and FcγR genotype by enzyme-linked immunosorbent assay (ELISA) and polymerase chain reaction (PCR).

Eligibility criteria: • Patients with HER-2-overexpressing node-positive or high-risk node-negative breast cancer enrolled on NCCTG-N9831

\* Pre- and post-treatment serum and DNA samples of patients treated with doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab (Herceptin®)

Primary outcomes:
measure: disease-free survival
timeFrame: up to 1 month
measure: overall survival
timeFrame: up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Keith L. Knutson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: