louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01572883: Effect of Concomitant Radiotherapy and Trastuzumab on Cardiotoxicity of Patients Treated for Early Breast Cancer
Official title: Effect of Concomitant Radiotherapy and Trastuzumab on Cardiotoxicity of Patients Treated for Early Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: adjuvant treatment with Radiotherapy and trastuzumab
Lead sponsor: Institute of Oncology Ljubljana
Sponsor class: OTHER
First posted: 2012-04-06
Enrollment: 175
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: breast cancer patients treated in Institut of Oncology Ljubljana,slovenia since year 2005.

Brief summary: The purpose of this study is to determine whether concomitant radiotherapy and trastuzumab (patients treated for early breast cancer) is really safe for the heart even years after treatment and if the investigators should use these two treatments concomitantly without additional harm.

Detailed description: The investigators know from the studies, that were already published, that for HER2 positive early breast cancer patients in adjuvant treatment concomitant radiotherapy and trastuzumab is safe during the treatment. But there is no study with long term results of cardial function, especially combination of Left ventricular ejection fraction (LVEF) and NT-proBNP.

Eligibility criteria: Inclusion Criteria:

* Early breast cancer patients,treated adjuvantly with radiotherapy of the operated breast or thoracic wall and treated concomitantly with trastuzumab.
* Reviewed many months after treatment, without recurrence of disease.

Exclusion Criteria:

* Recurrence of disease

Primary outcomes:
measure: difference in LVEF (Left Ventricular Ejection Fraction)
timeFrame: from one to six years from adjuvant radiotherapy for early breast cancer
Secondary outcomes:
measure: occurrence of cardiovascular events over time in both groups (RT for left/right breast)
timeFrame: from 6 months to five years after adjuvant therapy with trastuzumab
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Institut of oncology Ljubljana
Study officials:
affiliation: Institute of Oncology Ljubljana
name: Tanja Marinko, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01208883: A Feasibility Study On Continuous Adaptive [18f]Fdg-Pet-Guided Radiotherapy For Head and Neck Cancer
Official title: A FEASIBILITY STUDY ON CONTINUOUS ADAPTIVE [18F]FDG-PET-GUIDED RADIOTHERAPY FOR HEAD AND NECK CANCER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Squamous Cell Carcinoma
Keywords: Primary non-operated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2010-09-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Treatment adaptation to biological and anatomical changes occurring during treatment can increase the chance of cure at minimized radiation-induced toxicity in head and neck cancer patients. This trial investigates the feasibility of using repetitive per-treatment \[18F\]FDG-PET acquired during treatment in adaptive \[18F\]FDG-PET-voxel intensity-based intensity-modulated radiotherapy (IMRT) or volumetric-modulated arc therapy (VMAT) for head and neck cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx.
* Primary unresectable tumor and/or patients refused surgery.
* Stage T1-4; T3-4 N0 or Tany N1-3 for cancer of the glottis.
* Multidisciplinary decision of curative radiotherapy or radiochemotherapy.
* Karnofsky performance status ≥70%.
* Age ≥ 18 years old.
* Informed consent obtained, signed and dated before specific protocol procedures.

Exclusion Criteria:

* Treatment combined with brachytherapy.
* Prior irradiation to the head and neck region.
* Distant metastases.
* Second primary tumors that are not under control
* Pregnant or lactating women.
* Creatinine clearance (Cockcroft-Gault) ≤ 60 mL/min before treatment.
* Allergy to the CT-contrast agents.
* Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
* Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.

Primary outcomes:
measure: To assess volume changes of the targets and organs at risk as detected by repetitive per-treatment [18F]FDG-PET/CT.
timeFrame: at time of per-treatment [18F]FDG-PET/CT
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Wilfried De Neve, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06053983: Comparison Between Atorvastatin and Rosuvastatin in Reduction of Inflammatory Biomarkers in Patients With Acute Coronary Syndrome
Official title: Comparison Between Atorvastatin and Rosuvastatin in Reduction of Inflammatory Biomarkers in Patients With Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mi Q Wave
Lead sponsor: Rawalpindi Medical College
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 126
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: This study will help us to compare atorvastatin and rosuvastatin in terms of their ability to reduce biomarkers of inflammation in patients of acute coronary syndrome


Eligibility criteria: Inclusion Criteria:

1. Patients with age 18 years and above, of both genders, diagnosed with acute coronary syndrome (as per operational definition) who were not taking statins previously.
2. Patients who sign written informed consent to participate in the study.

Exclusion Criteria:

* 1.Patients who are taking either statins and/or any other drug which lower serum lipid levels, patients with a history of statin hypersensitivity, patients in whom statins are contraindicated.

  2.Patients who will be surgically managed will be also excluded. 3.if coronary revascularization will be planned or anticipated at the time of screening.

  4.Pregnant or lactating women. 5.Patients having concomitant infections which cause the rise of inflammatory markers.

Primary outcomes:
measure: Mean Change C-reactive protein
timeFrame: AFTER 4 WEEKS
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Rawalpindi Medical University
Study officials:
affiliation: Rawalpindi Medical College
name: asma khan
role: STUDY_DIRECTOR
References:
Clinical trial NCT04830683: Endothelial Dysfunction in Covid-19
Official title: Endothelial Dysfunction and Oxidative Stress in ICU and Non-ICU Covid-19 Patients With Hypoxemic Respiratory Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Hypoxemic Respiratory Failure
Keywords: Endothelial Dysfunction
Covid19
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patients for SARS-Cov-2 infection

Brief summary: SARS-CoV-2 targets endothelial cells via the angiotensin-converting enzyme 2 receptor. The specific impact of the resulting endothelial injury is currently unknown but may contribute to the pro-coagulant state classically described during Covid-19 disease and commonly associated with an exacerbated activation of the renin-angiotensin-aldosterone system.

Detailed description: We prospectively compared clinical and biological parameters in ICU- and non-ICU-admitted Covid-19 patients, ICU-admitted patients with septic shock unrelated to Covid-19 and matched control subjects.

Primary hemostasis and coagulation parameters and endothelial biomarkers are measured. Activation of the renin-angiotensin-aldosterone system is monitored through measurements of plasma renin, angiotensin II, aldosterone, and serum soluble angiotensin-converting enzyme 2. Vascular oxidative status is assessed by measuring plasma lipids peroxides. Neutrophilic polymorphonuclear activation is assessed by measuring plasma levels of Triggering receptor expressed on myeloid cells-1. Vascular nitric oxide bioavailability is measured by quantification of the concentration of heme-nitrosylated hemoglobin (HbNO) in venous erythrocytes using Electron Paramagnetic Resonance spectroscopy. Structural abnormalities of vascular endothelial cells were analyzed by Transmission Electron- and Scanning Electron Microscopy.

Eligibility criteria: Inclusion Criteria:

* positive result on a reverse-transcriptase-polymerase chain reaction testing performed on nasopharyngeal swab at hospital admission

Exclusion Criteria:

* ICU admission more than five days after admission on a general ward,
* concomitant bacterial infection
* older than 75 years
* cirrhosis

Primary outcomes:
measure: Vascular oxidative stress in Covid-19 versus septic shock and control patients
timeFrame: ICU or general ward hospital admission
Secondary outcomes:
measure: Vascular Renin-angiotensin-aldosterone system measurements in Covid-19 versus septic shock and control patients
timeFrame: ICU or general ward hospital admission
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
state: Belgique
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: VIRGINIE MONTIEL, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01561183: Vital Pulp Therapy (VPT) Using Calcium Enriched Mixture (CEM) to Treat Irreversible Pulpitis
Official title: Vital Pulp Therapy for Management of Irreversible Pulpitis in Human Permanent Teeth: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irreversible Pulpitis
Keywords: Vital pulp therapy
Pulp cap
pulpotomy
calcium enriched mixture
CEM cement
Endodontic
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 302
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effect of different VPT methods using Calcium Enriched Mixture (CEM) cement for management of human dental pulp with irreversible pulpitis.

Detailed description: The purpose of this randomized clinical trial is to demonstrate the effect of four methods of Vital Pulp Therapy (VPT) using a new endodontic bio-material \[calcium enriched mixture (CEM) cement\] in pain relief as well as clinical/radiographic success, for management of irreversible pulpitis of human permanent teeth.

Eligibility criteria: Inclusion Criteria:

1. Carious permanent vital mature molar tooth with closed apex (with preoperative X-ray)
2. Positive response to EPT or cold test
3. patients willing to participate in study
4. Healthy subjects; absence of any systematic disorder
5. Age ≥ 10 years old
6. Both gender
7. Written informed consent

Exclusion Criteria:

1. Moderate or severe periodontitis; pockets \>3mm
2. None restorable tooth
3. Internal or external root resorption
4. Root canal calcification
5. Non vital pulps
6. Analgesic taken within the last 8h
7. Active systemic disease
8. Pregnancy or nursing
9. History of opioid addiction/abuse
10. Temporary residency

Primary outcomes:
measure: Clinical and radiographical success rates (%) of each treatment group
timeFrame: 1 year
Secondary outcomes:
measure: Patient Assessment of Pain with questionnaire
timeFrame: 6-months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Imam Khomeini Dental Clinic
Study officials:
affiliation: Iran Center For Dental Research
name: Mohammad Jafar Eghbal, DDS, MS
role: STUDY_DIRECTOR
References:
citation: Asgary S, Ahmadyar M. Can miniature pulpotomy procedure improve treatment outcomes of direct pulp capping? Med Hypotheses. 2012 Feb;78(2):283-5. doi: 10.1016/j.mehy.2011.11.002. Epub 2011 Dec 1.
Clinical trial NCT00508183: Types of Fixation in Arthroscopic Rotator Cuff Repair
Official title: Single Row Versus Double Row Fixation in Arthroscopic Cuff Repair; a Randomized Controlled Sutdy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Keywords: full thickness rotator cuff tear
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2007-07-27
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will identify if there is a difference of quality of life after surgery between two techniques used in surgery. The two different techniques are either the Single Row Fixation or the Double Row Fixation.

Detailed description: Primary Research Question; What is the difference in disease specific quality of life between patients who undergo a repair of the rotator cuff with arthroscopic technique using single-row fixation, versus double-row fixation, as measured by the Western Ontario Rotator Cuff Index (WORC)at one year post op?

Eligibility criteria: Inclusion Criteria:

* Patients who have failed standard non-surgical management of their rotator cuff tear, and who would benefit from a surgical repair of the cuff.
* Imaging and intra-operative findings confirming a full thickness tear of the rotator cuff.

Exclusion Criteria:

* Characteristics of the cuff tear that render the cuff irrepairable.
* Significant shoulder comorbidities
* Previous surgery on affected shoulder
* Patients with active workers compensation claims
* Active joint or systemic infection
* Significant muscle paralysis
* Rotatorcuff tear arthropathy
* Charcots arthropathy
* Major medical illness
* Unable to speak or read English
* Psychiatric illness that precludes informed consent

Primary outcomes:
measure: Western Ontario Rotator Cuff Index (WORC)
timeFrame: 2 years
Secondary outcomes:
measure: Constant Score
timeFrame: 2 Year
measure: ASES Score
timeFrame: 2 Year
measure: Strength Test
timeFrame: 2 Years
measure: Healing Rate
timeFrame: 1 Year
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: OHRI
name: Peter Lapner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lapner PL, Sabri E, Rakhra K, McRae S, Leiter J, Bell K, Macdonald P. A multicenter randomized controlled trial comparing single-row with double-row fixation in arthroscopic rotator cuff repair. J Bone Joint Surg Am. 2012 Jul 18;94(14):1249-57. doi: 10.2106/JBJS.K.00999.
citation: Lapner P, Li A, Pollock JW, Zhang T, McIlquham K, McRae S, MacDonald P. A Multicenter Randomized Controlled Trial Comparing Single-Row With Double-Row Fixation in Arthroscopic Rotator Cuff Repair: Long-Term Follow-up. Am J Sports Med. 2021 Sep;49(11):3021-3029. doi: 10.1177/03635465211029029. Epub 2021 Aug 16.
Clinical trial NCT06422897: Role of AS-OCT in Assessment of Corneal Perforation
Official title: Role of Anterior Segment Optical Coherence Tomography in Assessment of Healing of Thin or Perforated Cornea Treated by Amniotic Membrane Graft and Platelet Rich Plasma Clot
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Perforation
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients from both sexes was thin cornea or small corneal perforation surgically treated by amniotic membrane graft and platelet rich plasma clot

Brief summary: Assessment of healing of thin and perforated cornea after surgical treatment by anterior segment optical coherence tomography

Detailed description: * thin and perforated cornea (small perforation) is surgically treated by amniotic membrane graft and platelet rich plasma clot
* anterior segment optical coherence tomography is performed preoperative and 1 month postoperative to assess healing

Eligibility criteria: Inclusion Criteria:

* thin cornea about to perforate
* small corneal perforation

Exclusion Criteria:

* active infection

Primary outcomes:
measure: Depth of corneal healing measured by optical coherence tomography
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: professor
name: Ahmed A Abdelghany, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdelghany AA, Bahrawy ME, Alio JL. Combined Platelet Rich Plasma and Amniotic membrane in the treatment of Perforated Corneal Ulcers. Eur J Ophthalmol. 2022 Jul;32(4):2148-2152. doi: 10.1177/11206721211049100. Epub 2021 Oct 8.
Clinical trial NCT03820297: Anti-stigma Intervention for Chinese American Older Adults
Official title: Effects Of Anti-Stigma Intervention For Chinese American Older Adults With Mood And Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood Disorders
Anxiety Disorders
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Substance Abuse and Mental Health Services Administration (SAMHSA)
First posted: 2019-01-29
Enrollment: 16
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Approximately 50 participants will be enrolled and screened to achieve 45 eligible patients with mood/anxiety disorders to complete a 10 weekly anti-stigma group intervention (ASGI) in addition to several self-report internalized stigma and psychiatric measures.This study will examine changes in internalized stigma and psychiatric symptoms pre- and post-ASGI with 3 months post-intervention follow-up.


Eligibility criteria: Inclusion Criteria:

* Self-reported Chinese heritage;
* 55 years or older
* Mandarin and/or Cantonese speaking and ability to read and/or comprehend spoken Chinese language.
* Currently receiving treatment from a mental health provider at Gouverneur Medical Center Asian Bicultural Clinic (GMC ABC) and willing to continue mental health care through the study.
* Willing to provide release for communication between primary mental health care provider and study staff throughout the study.
* Documented by mental health provider after consent for release of information as having mood and anxiety disorder diagnosis in the past year;
* A willingness to participate in the ASGI with stated availability;
* Able and willing to provide informed consent.

Exclusion Criteria:

* Lifetime psychosis, neurocognitive, or significant neurological disorders;
* Current manic episode;
* Past 6 months of alcohol/substance use disorder;
* Serious safety concerns of suicide or homicide.

Primary outcomes:
measure: Self stigma of mental illness scale
timeFrame: 23 weeks
measure: Recovery assessment scale
timeFrame: 23 weeks
measure: Self-protective Withdrawal and Secrecy scale
timeFrame: 23 weeks
Secondary outcomes:
measure: Changes in social support
timeFrame: 23 weeks
measure: Changes in patient depressive symptoms measured by Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 23 weeks
measure: Changes in patient anxiety symptoms associated with stigma reduction
timeFrame: 23 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Naomi Simon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05982197: Curcumin Gel On Radiation Induced Oral Mucositis
Official title: The Effect of Curcuma Long Oral Gel in Relation to Salivary Epidermal Growth Factor & Interleukin-8 on Radiation Induced Oral Mucositis in Iraqi Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation-Induced Mucositis
Head and Neck Cancer
Keywords: Radiation induced oral mucositis
Head and neck cancer
Curcuma longa
EGF
IL8
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups A) curcuma longa oral gel group B) standard treatment group
Primary purpose: PREVENTION

Brief summary: The goal of this clinical study is to investigate the effect of a curcuma longa oral gel (curenext) on reducing radiation-induced oral mucositis severity in cancer patients and provide a context for understanding if there is a relationship between the curcumin clinical effect and production of EGFs and IL8.

Researchers will compare between curcumin group and standard treatment group.


Eligibility criteria: Inclusion Criteria:

* Patients above 16 years having histopathologically confirmed cancer in head and neck region who planned to have radiation with head and neck mask.
* Scheduled for 6-8 weeks of radiotherapy with 60-70Gy radiation (200cgy/fraction for 5 days/week).

Exclusion Criteria:

* patient with hodgkin lymphoma.
* Any allergy to curcumin or other condiments.

Primary outcomes:
measure: Onset of radiation induced mucositis
timeFrame: Assessment every week starting from first visit until the onset of mucositis (up to 2 months)
measure: Change in severity of radiation induced mucositis
timeFrame: Assessment every week starting from first visit of radiation unit it completion (average of 2 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Nuclear medicine and radiation therapy hospital
Study officials:
References: