louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02741258: Mepitel Film Treatment for the Prevention and Cutaneous Toxicity Due to Radiotherapy
Official title: Mepitel Film vs Standard of Care for the Radiotherapy Prevention and Cutaneous Toxicity in Patients With Post-surgery Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-surgery Radiotherapy
Lead sponsor: Oncology Institute of Southern Switzerland
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 164
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized study, mepitel vs standard of care for the prevention and skin toxicity due to radiotherapy in patients with post-surgery breast cancer.

Mepitel film will be placed on the skin of the patients just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of toxicities.

Detailed description: For patients randomized in the mepitel arm:

Mepitel film will be placed on the patients' skin just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of the toxicities. In case of new skin toxicities appearance the patient will be retreated with mepitel.

For patients randomized in the standard of treatment arm:

Patients will be treated with aqueous (Excipial U hydrolotion) or antiseptic (Flammazine o Ialugen Plus) cream in case of skin erythema. In case of new skin toxicities appearance the patient will be retreated with standard of care treatment.

Eligibility criteria: Inclusion Criteria:

* patients with breast cancer treated with conservative surgery who need radiotherapy treatment
* capability and willness to participate to the study
* informed consent form signature

Exclusion Criteria:

* contraindication to the correct placement of the Mepitel Film
* previous breast radiation treatment
* participating in other clinical trials
* previous breast reconstruction
* concomitant treatment with antiblastic chemotherapy

Primary outcomes:
measure: Mepitel Film efficacy in treating skin toxicity evaluatet with Common Terminology Criteria for Adverse Events (CTCAE)
timeFrame: one week after start of radiotherapy
Secondary outcomes:
measure: Time for the skin toxicity appearance and resolution
timeFrame: one week after start of radiotherapy
measure: Severity of the chronic skin toxicity
timeFrame: one week after start of radiotherapy
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Oncology Institute of Southern Switzerland
city: Zürich
country: Switzerland
facility: Institut für Radiotherapie Klinik Hirslanden
Study officials:
affiliation: Oncology Institute of Southern Switzerland
name: Dario Valcarenghi
role: STUDY_CHAIR
References:
Clinical trial NCT04127058: Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia
Official title: A Safety/Tolerance Study to Evaluate a New Titration Scheme in Patients With Bipolar I Disorder or Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bipolar I Disorder
Schizophrenia
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-10-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-center open-label study to be conducted in the United States in subjects with bipolar I disorder or schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Male or female patients 18 to 65 years of age (inclusive)
* Diagnosed with either schizophrenia or bipolar I disorder, manic or mixed type as per DSM-V criteria
* Symptomatically stable within the past two months

Exclusion Criteria:

* Exposure to any investigational medication, including placebo, in the past 60 days
* Non-response to clozapine

Primary outcomes:
measure: The frequency of treatment-emergent adverse events as measured by the number of events
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Marlton
country: United States
facility: Vanda Investigational Site
state: New Jersey
Study officials:
References:
Clinical trial NCT04233658: Cynara Scolymus Extract for Treatment of Diabetes Mellitus Type 2
Official title: Cynara Scolymus Extract for Treatment of Diabetes Mellitus Type 2, a Pilot Clinical Trial Clinical Study Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 20
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: Edible parts of the artichoke plant (Cynara cardunculus, Cynara scolymus) are traditionally known in folk-medicine for lipid lowering and choleretic effects. Furthermore, antidiabetic effects are described. In the past year's research attributed health promoting effects to the main active compounds chlorogenic acid, luteolin and apigenin. Present literature indicates potential antidiabetic effects by different mechanisms like downregulation of gluconeogenesis, increased GLP-1 secretion and modification of insulin signalling. Up to now only few human clinical trials provide insufficient data to conclude the therapeutic potential of cynara scolymus extract in the treatment of type 2 diabetes.

The primary objective is to evaluate the antidiabetic effect and the mechanisms of glucose lowering by a 12-week treatment with a highly-standardized extract of cynara scolymus in subjects with diabetes mellitus type 2 compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Male or female ≥18 years old.
* Diagnosis of diabetes mellitus type 2 ≥ 90 days prior to screening
* HbA1c-level between 6.5-9%
* Body mass index of ≥ 28 kg/m2
* Stable daily dose (for at least 30 days) of 1-3 oral antidiabetic drug (metformin, sulfonylurea, SGLT-2 inhibitor, thiazolidinedione or DPP-IV-inhibitor)

Exclusion Criteria:

* Subjects with diabetes mellitus type 1 or history of ketoacidosis,
* Uncontrolled diabetes, defined as fasting plasma glucose ≥20mmol/l or recurrent hypoglycemia (defined as capillary glucose values ≤3.5mmol/l)
* Use of insulin or GLP-1-receptor agonists
* Women wanting to become pregnant
* Pregnant or breast-feeding women
* Known hepatic disorder
* Severe renal insufficiency (GFR ≤30ml/min)
* History of inflammatory bowel disease
* History of gastric bypass or gastric sleeve surgery
* Anticoagulation with vitamin K-antagonists

Primary outcomes:
measure: Change of HbA1c-level from baseline to week 12
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04927858: A Study Using Swedish Registries to Find Out How Many People With Type 2 Diabetes Had Cardiovascular Disease and Started Treatment With Empagliflozin Between 2015 and 2017
Official title: Prevalence of Cardiovascular Disease in Swedish Patients With Type 2 Diabetes and in Patients Initiating on Empagliflozin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-06-16
Enrollment: 460558
Sex: ALL
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: The study population includes patients with T2DM and age ≥18 years on 2017-12-31 and who had at least one registration in the Swedish National Diabetes Register (NDR) between 1996 - 2017.

Brief summary: This study aims to describe the prevalence of type 2 diabetes mellitus (T2DM) patients with established cardiovascular disease (CVD) according to the (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME (ERO)) study definition in a Swedish population.

The aim was also to describe the prevalence of established CVD according to ERO study definition in patients with T2DM who initiates treatment with empagliflozin


Eligibility criteria: Inclusion criteria

Population 1: 'Prevalence of a history of cardiovascular disease (CVD) among persons with type 2 diabetes mellitus (T2DM) who were alive on 31 December 2017' :

* Diagnosed with T2DM in Sweden
* Alive on 31 December 2017
* At least one registration in the Swedish National Diabetes Register (NDR)
* Each patient provides informed consent for inclusion in the register

Population 2: 'Prevalence of a history of CVD among persons with type 2 diabetes who started empagliflozin treatment between 1 January 2015 and 31 December 2017':

* Diagnosed with T2DM in Sweden
* Alive on 31 December 2017
* Initiated on empagliflozin between 1 January 2015 and 31 December 2017
* At least one registration in the NDR
* Each patient provides informed consent for inclusion in the register

Exclusion criteria:

none

Primary outcomes:
measure: Prevalence of a History of Cardiovascular Disease (CVD) Among Swedish Patients With Type 2 Diabetes Mellitus (T2DM) Who Were Alive on 31st of December 2017
timeFrame: Data collected at the index date 31st of December 2017, data covering a time period from 1996 until 2017, up to 21 years.
measure: Prevalence of a History of CVD Among Swedish Patients With T2DM Who Started Empagliflozin Treatment Between 1st of January 2015 and 31st of December 2017
timeFrame: Data collected at the index date 31st of December 2017, data covering a time period from 1996 until 2017, up to 21 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Boehringer Ingelheim AB
Study officials:
References:
Clinical trial NCT05040958: Carotid Atherosclerotic Plaque Load and Neck Circumference
Official title: Determination of Carotid Atherosclerotic Plaque Load and Neck Circumference in Cranial CT Angiography With Machine Learning Method and Their Relationship With Each Other
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atherosclerosis of Artery
Metabolic Syndrome
Machine Learning
Keywords: Atherosclerosis of Artery
Metabolic Syndrome
Machine Learning
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People having cranial CTA

Brief summary: The aim of this study is to establish a deep learning model to automatically detect the presence and scoring of carotid plaques in neck CTA images, and to determine whether this model is compatible with manual interpretations.

Detailed description: Modeling CTA images for carotid artery segments with deep learning method and automatic carotid plaque presence and scoring will be useful and beneficial in clinical practice. The aim of this study is to establish a deep learning model to automatically detect the presence and scoring of carotid plaques in neck CTA images, and to determine whether this model is compatible with manual interpretations.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Having cranial CTA withdrawn
* Having blood lipids, HbA1c, blood glucose, AST, ALT measured in 3 months before and 3 months after cranial CTA

Exclusion Criteria:

* Thyroid disease
* Having had neck surgery
* Use of corticosteroids for more than 6 months
* Presence of lymph nodes in the anterior neck
* Hypertrophy of neck muscles

Primary outcomes:
measure: Correlation of the machine learning model and manual interpretation
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Kadıköy
country: Turkey
facility: Istanbul MEdeniyet University Göztepe Prof. Dr. Süleyman Yalçın City Hospital
state: İstanbul
Study officials:
affiliation: Sultan Abdülhamid Han Training and Research Hospital
name: Elif Yıldırım Ayaz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00435058: Visual Function Changes After Intraocular Pressure Reduction
Official title: Visual Function Changes After Intraocular Pressure Reduction Using Antiglaucoma Medications: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: intraocular pressure
contrast sensitivity
visual function
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2007-02-14
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During the glaucomatous disease process, subpopulations of cells may be dead, damaged or healthy. Visual function changes could be observed due to a recovering of the suffering ganglion cells after the intraocular pressure reduction. This study aims at evaluating the correlation between intraocular pressure reduction and visual function changes in glaucoma patients after using antiglaucoma medications.

Detailed description: Primary open angle glaucoma patients without use of antiglaucoma medications will be enrolled in this study. After inclusion, the patients will randomly receive one of three antiglaucoma medications (timolol maleate 0,5%, brimonidine tartrate 0,2% or travoprost 0,004%) in one randomly selected eye.

The patients will be evaluated with Goldmann applanation tonometry, visual acuity test, contrast sensitivity test, visual quality perception test (visual analogue scale) and standard automated perimetry before and after 4 weeks of glaucoma treatment onset.

Eligibility criteria: Inclusion Criteria:

* Primary open angle glaucoma
* Intraocular pressure greater than 21 mmHg

Exclusion Criteria:

* Best corrected visual acuity (BCVA) worse than 20/80
* Significant media opacity
* History of steroid use

Primary outcomes:
measure: intraocular pressure
measure: contrast sensitivity
measure: visual quality perception
Secondary outcomes:
measure: Mean deviation of the visual field (MD)
measure: Pattern Standard Deviation of the visual field (PSD)
measure: visual acuity
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Tiago Prata, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Luiz A Melo Jr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05592158: Evaluation of the Effectiveness of an Amnion-chorion Membrane for Alveolar Ridge Preservation
Official title: Evaluation of the Effectiveness of an Amnion-chorion Membrane for Alveolar Ridge Preservation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healing Wound
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine whether adding an amnion-chorion membrane on top of the traditionally used collagen plug will lead to more bone formation compared to the collagen plug only.

Detailed description: Bone grafts and membranes are commonly placed to increase the amount of bone right after tooth extraction and before placing a dental implant. The primary objective of this study is to study the effect of a human amnion-chorion membrane (ACM) in an exposed-barrier ridge preservation technique to a control group without utilizing a ACM.

30 patients requiring a front tooth extraction will be recruited and randomized to receive bone grafting with or without an ACM.

Eligibility criteria: Inclusion Criteria:

1. Age range: 20 to 80 years.
2. Patients must require tooth extraction (for incisors, canines and premolars) as a result of caries, periodontal disease, tooth fracture or deemed unrestorable.
3. Socket should be free of infection, less than 5mm of dehiscence
4. Patients interested in implant placement following tooth extraction.

Exclusion Criteria:

1. Allergies or hypersensitivities to study related medications such as chlorhexidine.
2. Hematologic disorders/blood dyscrasias.
3. Active infectious diseases of any kind.
4. Liver or kidney dysfunction/failure.
5. Uncontrolled diabetes (HbA1c \> 8).
6. Active cancer treatment - such as active chemotherapy or radiation therapy.
7. Taking medications that will affect their bone healing (for example, bisphosphonates).
8. Metabolic bone diseases that affect bone healing such as osteoporosis.
9. Pregnant or lactating women (self-reported).
10. Smoke 10 or more cigarettes per day (self-reported).
11. Poor oral hygiene.

Primary outcomes:
measure: Clinical alveolar ridge dimension changes
timeFrame: 4 months
measure: Digital alveolar ridge dimension changes
timeFrame: 4 months
Secondary outcomes:
measure: Histological bone density.
timeFrame: 4 months
measure: Presence of bone turnover proteins.
timeFrame: 4 months
measure: Implant survival-Clinical
timeFrame: 6 months
measure: Implant survival-Radiographic
timeFrame: 6 months
measure: Esthetic restorative outcomes.
timeFrame: 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry
state: Michigan
Study officials:
affiliation: University of Michigan
name: Muhammad Saleh, BDS, MSD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02079558: Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section
Official title: Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postpartum Hemorrhage
Keywords: prevention
cesarean section
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-03-06
Enrollment: 220
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Postpartum hemorrhage (PPH) is a common complication of childbirth and a leading cause of maternal morbidity and mortality. The prompt and effective treatment of subjects with PPH would reduce operation risks. Hence in this study, the efficacy of Oxytocin and Carbetocin was compared in prevention of postpartum hemorrhage after cesarean sections.


Eligibility criteria: Inclusion Criteria:

* At least one risk for postpartum hemorrhage and lack of hypersensitivity to oxytocin and carbetocin

Exclusion Criteria:

* Patients' refusal to cooperate, major therapeutic side effects, history of cardiac and renal disease or preeclampsia

Primary outcomes:
measure: screening of Cessation of bleeding
timeFrame: screening until 24 hours after placenta disconnection
measure: time duration to stop bleeding in the case of post-cesarean section
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Infertility and Reproductive Health Research Center
Study officials:
affiliation: Infertility and Reproductive health Research center, Imam Hossien hospital, Shahid Beheshti Medical university, Tehran, Iran
name: Robabeh Taheripanah, MD-Gyn.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taheripanah R, Shoman A, Karimzadeh MA, Zamaniyan M, Malih N. Efficacy of oxytocin versus carbetocin in prevention of postpartum hemorrhage after cesarean section under general anesthesia: a prospective randomized clinical trial. J Matern Fetal Neonatal Med. 2018 Nov;31(21):2807-2812. doi: 10.1080/14767058.2017.1355907. Epub 2017 Jul 25.
Clinical trial NCT04483258: Sevoflurane Insufflation vs Intravenous Sedation for Radiotherapy in Pediatric Patients
Official title: Cross-over Analysis of Sevoflurane Insufflation and Intravenous Sedation for Radiotherapy in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Sedation
Radiotherapy
Inhalation Anesthesia
Keywords: insufflation sedation
intravenous sedation
radiotherapy anesthesia
pediatric sedation
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Sevoflurane insufflation and intravenous sedation will be applied to the patients by changing them sequentially during each radiotherapy session.
Primary purpose: SUPPORTIVE_CARE

Brief summary: aim of this cross-over study is to compare sedation with insufflated sevoflurane and intravenous sedation for pediatric radiotherapy patients

Detailed description: aim of this cross-over study is to compare sedation with insufflated sevoflurane and intravenous sedation for pediatric radiotherapy(RT) patients in terms of success of the procedure (continuous completion of the RT session by providing inactivity) and complications such as desaturation, hypoventilation, airway spasm, bradycardia, tachycardia In addition, we aimed to investigate the incidence of anesthesia complications in RT patients and possible related factors with complications.

Eligibility criteria: Inclusion Criteria:

* undergoing radiotherapy session

Exclusion Criteria:

* family refusal
* chronic nausea and vomiting
* apnea history, pneumonia, asthma, bronchiolitis etc. respiratory tract infection or diseases
* cardiac disease
* kidney failure
* liver failure
* anticipated difficult airway
* metabolic diseases
* neurological or muscular diseases.

Primary outcomes:
measure: number of the successful radiotherapy sessions
timeFrame: during radiotherapy session
measure: number of interruptions
timeFrame: during radiotherapy session
measure: PSSS
timeFrame: during radiotherapy session
Secondary outcomes:
measure: sPO2
timeFrame: during radiotherapy session
measure: HR
timeFrame: during radiotherapy session
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: Ankara City Hospital Anesthesiology Department
name: İsmail Aytac
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00280358: A Study in Healthy Volunteers to Evaluate Serum and Urine Levels of the Investigational Product Versus Comparator.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Fluticasone
Formoterol
PK Study
Pharmacokinetics
Lead sponsor: Dey
Sponsor class: INDUSTRY
First posted: 2006-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to obtain initial pharmacokinetic data in healthy patients after dosing a combination of the study medications.


Eligibility criteria: Inclusion Criteria:

* Non-smokers, BMI 18-29, no current medications

Exclusion Criteria:

* Significant conditions or disease

Primary outcomes:
measure: Levels of study medication in blood and urine.
Secondary outcomes:
measure: Safety/tolerability
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Research Site
state: Kansas
Study officials:
References: