louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03461224: Modulated Accelerated RAdiotherapy in Early Breast Cancer
Official title: Postoperative Modulated Accelerated RAdiotherapy (MARA-1) for Early Stage Breast Cancer: a Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Radiation Toxicity
Keywords: breast cancer
radiotherapy
cutaneous toxicity
subcutaneous toxicity
IMRT
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 447
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From 2003, all women fullfilling the inclusion criteria were treated with MARA-1 scheme

Brief summary: This trial was a retrospective study on postoperative accelerated hypofractionated IMRT (MARA-1) in patients with early stage breast carcinoma, to compare late toxicity after this treatment and standard fractionated RT delivered with 3D-CRT.

Detailed description: The aim of this study was to evaluate the clinical results in terms of late skin and subcutaneous toxicity of accelerated hypofractionated forward-planned IMRT in patients with early stage BC. Results were compared with a historical control group (CG) of patients treated with 3D-conformal postoperative RT delivered with conventional fractionation.

Eligibility criteria: Inclusion Criteria:

* confirmed histologic evidence of pTis-pT3 breast cancer
* breast conservative surgery
* post menopausal status
* clear surgical margin

Exclusion Criteria:

* pT4
* positive or close resection margins
* 3 or more metastatic axillary nodes
* nodal irradiation
* M1

Primary outcomes:
measure: Incidence of treatment-related late adverse events
timeFrame: 5 years
Secondary outcomes:
measure: Incidence of treatment-related acute adverse events
timeFrame: 6 months
measure: local control
timeFrame: 5 years
measure: overall survival
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy
name: Alessio G. Morganti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Digesu C, Deodato F, Macchia G, Cilla S, Pieri M, Zamagni A, Farioli A, Buwenge M, Ferrandina G, Morganti AG. Hypofractionated radiotherapy after conservative surgery may increase low-intermediate grade late fibrosis in breast cancer patients. Breast Cancer (Dove Med Press). 2018 Oct 3;10:143-151. doi: 10.2147/BCTT.S167914. eCollection 2018.
Clinical trial NCT05208424: New Diabetes Mellitus and Pre-Diabetes With First-time Diagnosed Coronary Artery Disease
Official title: Incidence, Characteristics and Outcome of Patients With New Diabetes Mellitus and Pre-Diabetes With First-time Diagnosed Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PreDiabetes
Diabetes
Coronary Artery Disease
Lead sponsor: Saud Al Babtain Cardiac Center
Sponsor class: OTHER_GOV
First posted: 2022-01-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients with first time diagnosed coronary artery disease, based on invasive coronary angiography, with no prior history of dysglycemia will be enrolled from all comers to Saud AlBabtain Cardiac Center

Brief summary: A prospective analytic study to evaluate the incidence, clinical and laboratory characteristics, extent of coronary artery disease and short-term outcome of newly diagnosed diabetes and pre-diabetes in patients with first-time diagnosed coronary artery disease treated in Saud Al Babtain Cardiac Center.


Eligibility criteria: Inclusion Criteria:

* First time diagnosed coronary artery disease as confirmed by invasive coronary angiography
* Emergently or electively admitted as coronary artery disease patients.
* Informed consent form

Exclusion Criteria:

* Prior diagnosis of diabetes or pre-diabetes based on the diagnostic criteria of the American Diabetes Association (ADA, 2020)
* Known coronary artery disease

Primary outcomes:
measure: Incidence
timeFrame: Through study completion, an average of 2 year
measure: Characteristics, clinical and laboratory
timeFrame: Through study completion, an average of 2 year
measure: Coronary artery disease severity
timeFrame: Through study completion, an average of 2 year
measure: Short-term outcome
timeFrame: From admission to 1-month follow up.
Secondary outcomes:
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: Saud AlBabtain Cardiac Center
Study officials:
References:
citation: American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S15-S33. doi: 10.2337/dc21-S002.
citation: Zhang YJ, Iqbal J, Campos CM, Klaveren DV, Bourantas CV, Dawkins KD, Banning AP, Escaned J, de Vries T, Morel MA, Farooq V, Onuma Y, Garcia-Garcia HM, Stone GW, Steyerberg EW, Mohr FW, Serruys PW. Prognostic value of site SYNTAX score and rationale for combining anatomic and clinical factors in decision making: insights from the SYNTAX trial. J Am Coll Cardiol. 2014 Aug 5;64(5):423-32. doi: 10.1016/j.jacc.2014.05.022.
Clinical trial NCT03358524: Effects of Vitamin E Supplementation on Free Radicals and Fat Level of Obese Adolescence in Jakarta, Indonesia
Official title: Effects of Vitamin E (Alfa-Tocoferol) Supplementation on Isoprostane and Lipid Profile of Obese Adolescent in Jakarta, Indonesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity, Adolescent
Oxidative Stress
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 69
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluate supplementation of vitamin E (alpha-tocopherol) in obese adolescent. Half of the patient will receive vitamin E and the other half received placebo

Detailed description: One of obesity treatments that play important role is antioxidant diet. The effects of vitamin E supplementation as an antioxidant treatment in obese adolescent have not been concluded yet in Indonesia. The primary aim of this study is to observe oxidative stress biomarker (isoprostane) in obese teenagers who consume vitamin E for 2 months. The secondary aim is to observe their body mass index and lipid profile after supplementation

The study is randomized, double blind, placebo controlled trial in design and employed a consecutive sampling technique to sample subjects of 70 obese adolescent age 14 - 18 in senior high schools Jakarta.

Blood tests of lipid profile (total cholesterol, HDL, LDL, Triglyceride), fasting blood glucose, liver function (AST,ALT) and oxidative stress biomarker (isoprostane) were taken for every subject after done fasting for 12 hours.

This study is a randomized allocation and double blind technique. subjects divided into two groups, which one group receiving treatment of vitamin E and other group receiving placebo.

The dose and duration of vitamin E treatment is 400 IU per day for 2 months. At the end of treatment, all subjects had to run the same medical interview, physical examination and blood test.

Eligibility criteria: Inclusion Criteria:

* Obesity BMI ≥ p95 (CDC growth curve)

Exclusion Criteria:

* Consuming antioxidants drug regularly within recruiting time
* Consuming Orlistat

Primary outcomes:
measure: Isoprostane (oxidative stress)
timeFrame: 8 weeks
Secondary outcomes:
measure: Total Cholesterol
timeFrame: 8 weeks
measure: LDL Cholesterol
timeFrame: 8 weeks
measure: HDL Cholesterol
timeFrame: 8 weeks
measure: Triglycerides
timeFrame: 8 weeks
measure: Body weight
timeFrame: 8 weeks
measure: Body Height
timeFrame: 8 weeks
measure: BMI
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: SMA Labschool
Study officials:
References:
Clinical trial NCT01315535: Fast Titration of Oral Appliance at Obstructive Sleep Apnea Syndrome (OSAS) Treatment
Official title: Evaluation of the Efficacy and Side Effects of Fast Mandibular Advancement With Oral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Mandibular Advancement
Oral Appliance
TMD
Lead sponsor: Associacao Fundo de Incentivo a Psicofarmcologia
Sponsor class: OTHER
First posted: 2011-03-15
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects diagnosed with mild to moderate osas, according to the aasm criteria (2005) from the respiratory disorders clinic (UNIFESP) referred to oral appliance treatment.

Brief summary: The literature does not discuss if the fast oral appliance titration (30 days period) in Obstructive Sleep Apnea Syndrome (OSAS) treatment, may improve subjects quality of life in such brief period. Temporomandibular dysfunction-related (TMD) is one of the most important side effects observed in OSAS treatment with oral appliance. Since the effectiveness of mandibular exercises in the control of TMD pain has already been verified, it may play a fundamental role in the support of the fast oral appliance titration.


Eligibility criteria: Inclusion Criteria:

* BMI ≤ 35kg/m2
* MILD TO MODERATE OSAS DIAGNOSIS ACCORDING TO THE AASM CRITERIA (2005)
* Negative TMD diagnosis (according to RDC/TMD)

Exclusion Criteria:

* DENTAL CONDITIONS THAT CONTRAINDICATED THE ORAL APLLIANCE USAGE
* SLEEP DISORDERS OTHER THAN OSAS

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto Do Sono / Universidade Federal de São Paulo
Study officials:
References:
Clinical trial NCT00886535: Effect of Pharmacogenomics Differences in Phase I and II Metabolism of Tamoxifen on Efficacy and Toxicity
Official title: An Observational Trial of the Effect of Pharmacogenomics Differences in Phase I and II Metabolism of Tamoxifen on Efficacy and Toxicity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Ductal Carcinoma in Situ
Keywords: breast cancer
hot flashes
tamoxifen
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2009-04-23
Enrollment: 41
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: Females, age 18 years of age and above. Patients receiving tamoxifen for adjuvant therapy of breast cancer or ductal carcinoma in situ or as chemoprevention.

Brief summary: This study will be an open-label prospective observational trial designed to test associations between polymorphisms of candidate genes and tamoxifen. Pre- and post-menopausal women taking tamoxifen as standard therapy or chemopreventive therapy will be included in this study.

Detailed description: This study will be an open-label prospective observational trial designed to test associations between polymorphisms of candidate genes (focusing initially on the UGT2B7 enzyme) and tamoxifen (TAM) toxicity. Pre- \& post-menopausal women (aged ≥18 years) taking TAM (20 mg/day) as standard therapy or chemopreventive therapy will be included in this study. Patients will be enrolled after they complete all primary surgery, radiation, and adjuvant chemotherapy. Patients will be excluded if they are undergoing other adjuvant endocrine therapies. Other reasons for exclusion will include patients who are pregnant or lactating, or are currently on corticosteroids, phenobarbital, or megestrol acetate. The goal will be to recruit a total of 45 eligible patients over a 1 year accrual period. The investigators expect to treat \~50 new patients per year with TAM at the standard dose of 20 mg/day.

Eligibility criteria: Inclusion Criteria:

* Patients receiving tamoxifen for adjuvant therapy of breast cancer or ductal carcinoma in situ, or as chemoprevention
* Age 18 years and above
* May be pre- and post-menopausal
* Females
* Patients may be at any point in their hormonal treatment, but must have completed any planned surgery, radiation and chemotherapy
* Must use a reliable form of birth control

Exclusion Criteria:

* Pregnant
* Breastfeeding
* Concurrent use of corticosteroids, megestrol, or phenobarbital
* History of allergy to tamoxifen
* Unwilling to have a yearly gynecological exam

Primary outcomes:
measure: Hot flashes
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Cancer Institute
state: Pennsylvania
Study officials:
affiliation: Penn State Hershey Cancer Institute
name: Leah Cream, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06684535: Dexmedetomidine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain
Official title: Role of Dexmedetomidine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dexmedetomidine
Adjuvant
External Oblique Intercostal Plane Block
Thoracotomy
Pain
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 40
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 aims to evaluate the role of dexmedetomidine as an adjuvant in external oblique intercostal plane block for post-thoracotomy pain.

Detailed description: External oblique intercostal plane block (EOIPB) is a novel block that has been described as an important modification of the fascial plane blocks that can consistently involve the upper lateral abdominal walls.

Dexmedetomidine is a selective alpha 2- adrenoceptor agonist possessing sedative, anxiolytic, and analgesic properties without the development of respiratory depression.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-III.
* Scheduled for open thoracotomy.

Exclusion Criteria:

* Patients with neurological or intellectual disability.
* Infection at the injection site.
* Drug abuse.
* Allergic reaction to local anesthetics.
* Coagulation abnormalities.
* Pregnancy.
* Body Mass Index (BMI) ≥35 kg/m2.
* Severe cardiovascular problems.
* Diabetic neuropathy.

Primary outcomes:
measure: Time to the 1st rescue analgesia
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: Intraoperative fentanyl consumption
timeFrame: Intraoperatively
measure: Total morphine consumption
timeFrame: 48 hours postoperatively
measure: Degree of pain
timeFrame: 48 hours postoperatively
measure: Heart rate
timeFrame: Every 15 min till the end of surgery
measure: Mean arterial pressure
timeFrame: Every 15 min till the end of surgery
measure: Incidence of adverse events
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT05047835: Comparison of Prone Position and Standard Electrocardiogram in COVID-19 Patients
Official title: Comparison of Prone Position and Standard Electrocardiogram in COVID-19 Patients: A Prospective Study in Specialized COVID-19
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19 Acute Respiratory Distress Syndrome
Cardiovascular Diseases
Arrhythmias, Cardiac
Keywords: COVID-19
electrocardiogram
ARDS
Prone position
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COVID-19 patients proved by nasal and pharyngeal swab for PCR, who were admitted to the COVID-19 specialized ward and were diagnosed with pulmonary infiltration from a chest x-ray.

Brief summary: Prolonged prone position ventilation reduces the 30-day mortality in acute respiratory distress syndrome (ARDS) and in COVID-19 infection.

A large number of patients with COVID-19 suffered from new-onset cardiac disease, therefore, ECG is crucial.

However, there is limited data on the effects of prone position on the ECG in COVID-19 patients.

Detailed description: Prolonged prone position ventilation reduces the 30-day mortality in acute respiratory distress syndrome (ARDS) and in COVID-19 infection. The evidence showed that a large number of patients with COVID-19 suffered from new-onset cardiac disease due to inflammatory processes or cytokine storm, therefore, ECG is crucial for making the diagnosis including arrhythmias and myocardial infarction. However, there is limited data on the effects of prone position on the ECG in COVID-19 patients. Therefore, we aimed to identify differences of electrical parameters between prone position and standard ECG including the difference in amplitude and duration of P, QRS, PR interval, QT interval, ST-segment between both positions (supine and prone). Furthermore, we aimed to compare clinical diagnosis from EKG between prone position and standard ECG by the cardiologists.

Eligibility criteria: Inclusion Criteria:

* COVID-19 patients who were admitted to the COVID-19 specialized ward
* Age 18 -80 years old
* Suffered from pulmonary infiltration

Exclusion Criteria:

* Intubated patients
* Cardiac arrest patients whether at presentation or during the study period
* ECG cannot be performed due to anatomical defects or superficial skin problems

Primary outcomes:
measure: The change of P wave amplitude
timeFrame: The first day of admission
measure: The change of QRS-complex amplitude
timeFrame: The first day of admission
measure: The change of T wave amplitude
timeFrame: The first day of admission
Secondary outcomes:
measure: Diagnosis
timeFrame: The first day of admission.
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Khon Kaen Unversity
Study officials:
References:
Clinical trial NCT02878135: Fast Versus Slow Application of Vulsellum During Intrauterine Device Insertion
Official title: the Effect of Slow Versus Fast Application of Vulsellum on Pain Perception During Intrauterine Device Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Improving Quality of Life
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: intrauterine device insertion requires use a vulsellum to stabilize the cervix. Patient's often complain that its placement is one of the most uncomfortable parts of this procedure


Eligibility criteria: Inclusion Criteria:

* Women not taken analgesics or anxiolytics in the 24 hours prior insertion
* Women not taken misoprostol prior to intrauterine device insertion
* Women who will accept to participate in the study

Exclusion Criteria:

Any contraindication to intrauterine device placement

Primary outcomes:
measure: mean Pain score with vulsellum placement
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
affiliation: Assiut University
name: Ahmed Abbas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00076635: An Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF
Official title: An Open-Label Study of the Safety of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Lung Disease
Keywords: Idiopathic
Pulmonary
Fibrosis
IPF
Lung
Actimmune
Interferon
Gamma
InterMune
Lead sponsor: InterMune
Sponsor class: INDUSTRY
First posted: 2004-01-30
Enrollment: 91
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open-label therapy will be administered to up to 220 patients, following completion of either InterMune Protocol GIPF-002 Part B or Protocol GIPF-004, to assess the long-term safety of subcutaneous Interferon gamma-1b. The study duration will be 5 years.

Detailed description: Open-label therapy will be administered subcutaneously. Patients enrolled will continue to receive Interferon gamma-1b therapy three times per week and will be evaluated at 6-week intervals. Patients not taking Interferon gamma-1b at enrollment will re-initiate therapy with subcutaneous Interferon gamma-1b under a dose-escalation scheme, reaching full dose after 2 weeks.

Eligibility criteria: Inclusion criteria:

* Enrollment in Protocol GIPF 002 Part B or GIPF-004
* Completion of the End of Treatment Visit in Protocol GIPF-002 Part B or the Study Completion Visit in GIPF-004
* Able to understand and sign a written informed consent form and comply with the requirements of the study

Exclusion criteria:

* pregnancy or lactation
* lack of adherence to either GIPF-002 or GIPF-004 study protocols and treatment regimens
* if Principal Investigator deems patient is unsuitable for study

Primary outcomes:
measure: All adverse events up to the end of study
timeFrame: 3.5 years
measure: Survival status at end of study
timeFrame: 3.5 years
measure: Serum antibodies to Interferon gamma-1b after the last injection.
timeFrame: 3.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brisbane
country: United States
facility: Intermune Inc
state: California
Study officials:
affiliation: Medical Information
name: InterMune, Inc. 888-486-6411
References: