louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01499602: Efficacy of LNG-IUS for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women
Official title: LNG-IUS or Norethisterone Acetate for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Hyperplasia
Keywords: Endometrial hyperplasia,
LNG-IUS,
Progestin
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2011-12-26
Enrollment: 120
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of the Levonorgestrel releasing Intrauterine System (Mirena) and Norethisterone Acetate for treatment of non-atypical endometrial hyperplasia in perimenopausal women.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed simple or complex endometrial hyperplasia without atypia

Exclusion Criteria:

* Endometrial hyperplasia with atypia
* Other pathology e.g. patients with fibroids of any size, genital infection, adnexal abnormality.

Primary outcomes:
measure: Change in endometrial histopathology pattern from endometrial hyperplasia into regression status.
timeFrame: At 3 and 6 months
Secondary outcomes:
measure: Time to achieve complete regression
timeFrame: During the follow up period at 3,6,12 months after treatment
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospitals,OB/GYN department
state: Dakahlia Governorate
Study officials:
affiliation: Mansoura University Hospital
name: Hatem Abu Hashim, MD. MRCOG
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reed SD, Voigt LF, Newton KM, Garcia RH, Allison HK, Epplein M, Jordan D, Swisher E, Weiss NS. Progestin therapy of complex endometrial hyperplasia with and without atypia. Obstet Gynecol. 2009 Mar;113(3):655-662. doi: 10.1097/AOG.0b013e318198a10a.
citation: Lee SY, Kim MK, Park H, Yoon BS, Seong SJ, Kang JH, Jun HS, Park CT. The effectiveness of levonorgestrel releasing intrauterine system in the treatment of endometrial hyperplasia in Korean women. J Gynecol Oncol. 2010 Jun;21(2):102-5. doi: 10.3802/jgo.2010.21.2.102. Epub 2010 Jun 30.
Clinical trial NCT00783302: Study in Subjects Suspected of Having CAD Undergoing VISIPAQUE-enhanced CCTA as Part of Their Routine Medical Care
Official title: A Prospective, Multi-Center Registry Study for Clinical Outcome in Subjects Undergoing Coronary Computed Tomography Angiography (CCTA) Examination (VISIPAQUE Registry Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease (CAD)
Keywords: CAD
Visipaque
CCTA
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 885
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient suspected of having coronary artery disease or CAD.

Brief summary: To assess prognostic value of CCTA examination in subjects who undergo CCTA as part of their medical care when compared to a standard of truth, i.e. subject outcomes during each follow-up period.


Eligibility criteria: Inclusion Criteria:

* The subject is over 18 years old, exhibits chest pain syndrome and is scheduled to undergo a VISIPAQUE-enhanced CCTA examination for one of the following reasons:- Intermediate pre-test probability of CAD.
* An uninterruptible/equivocal stress test (exercise, perfusion, or stress echo).

Primary outcomes:
measure: The Sensitivity of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Predicting Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).
timeFrame: Within 1 month, 6 months and 12 months post contrast administration.
measure: The Positive Predictive Value (PPV) of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).
timeFrame: Within 1 month, 6 months and 12 months post contrast administration.
measure: The Specificity of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).
timeFrame: Within 1 month, 6 months and 12 months post contrast administration.
measure: The Negative Predictive Value (NPV) of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).
timeFrame: Within 1 month, 6 months and 12 months post contrast administration.
Secondary outcomes:
measure: Summary of Subjects Developing 1 or More Positive and Negative Cardiac Clinical Outcomes at 1 Month, 6 Months, and 12 Months After Undergoing Coronary Computed Tomography Angiography (CCTA) Examination Using Visipaque.
timeFrame: Within 1 month, 6 months and 12 months post contrast administration.
Other outcomes:
Locations:
city: Princeton
country: United States
facility: GE Healthcare
state: New Jersey
Study officials:
affiliation: GE Healthcare
name: Rubin Sheng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00475202: Hyperbaric Oxygen Therapy and Angiogenesis in Diabetic Patients With Foot Ulcers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Foot Ulcers
Hyperbaric Therapy
Angiogenesis
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-05-21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Diabetic foot ulcers are a major cause of morbidity and mortality, accounting for approximately two-thirds of all non-traumatic amputations performed in the United States. The cost of foot ulcers in diabetic patients averages almost $28,000 for the two years after diagnosis of the ulcer. Hyperbaric oxygen (HBO) serves as primary or adjunctive therapy for a diverse range of medical conditions. HBO also has been used as an adjunct to antibiotics, debridement, and revascularization in the therapy of chronic, nonhealing wounds associated with diabetes or non-diabetic vascular insufficiency.

The aim of the study is to assess whether hyperoxia induced angiogenesis in diabetic patients with foot ulcers.


Eligibility criteria: Inclusion Criteria:

* age 18 years or older, with type II diabetes suffering from foot ulcers admitted to the Institute of Hyperbaric Medicine and Wound Care Clinic at Assaf Harofeh Medical Center (Israel)

Exclusion Criteria:

* Patients having chest pathology incompatible with pressure changes, inner ear disease, or suffering from claustrophobia, will be excluded from the study. Patients with significant macrovascular disease, defined as obstruction of more than 50% in the femoral or the popliteal arteries, will also be excluded from the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Institute of Hyperbaric Medicine and Wound Care Clinic at Assaf Harofeh Medical Center
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Albert Rabinovitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assaf-Harofeh Medical Center
name: Efrati Shai, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00870402: Aldosterone in Diabetic Nephropathy
Official title: Effect of Aldosterone Antagonism in the Reduction of Albuminuria and Diastolic Disfunction of Patients With Diabetic Nephropathy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetic Nephropathy
Keywords: aldosterone
albuminuria
diastolic disfunction
hyperkalemia
Lead sponsor: Universidad de los Andes, Chile
Sponsor class: OTHER
First posted: 2009-03-27
Enrollment: 160
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: 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 spironolactone are effective in the reduction of albuminuria and diastolic disfunction of subjects with diabetic nephropathy.


Eligibility criteria: Inclusion Criteria:

* Diabetic subjects with maximum ten years after diagnostic
* Diabetic nephropathy with albuminuria
* Normal renal function
* Diastolic disfunction
* Taking a IECA or ARA drug family previously

Exclusion Criteria:

* Diabetics subjects with macroangiopathy
* Acute coronary syndrome in the three months before
* Hyperkalemia \> 5.5 mEq/L
* Pregnancy

Primary outcomes:
measure: Reduction of albuminuria
timeFrame: 9 months
Secondary outcomes:
measure: Reduction of diastolic disfunction
timeFrame: 9 months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: University of Los Andes
Study officials:
References:
citation: Kozie DW, Hassul M, Kimm J. Effect of tympanic membrane perforations on air caloric response in monkeys. Trans Sect Otolaryngol Am Acad Ophthalmol Otolaryngol. 1976 Mar-Apr;82(2):203-9. No abstract available.
citation: Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.
Clinical trial NCT00369902: The Effect of Acupuncture Treatment on the Perception of Pain and Coping With Pain
Official title: Pilot Study on the Effect of Acupuncture Treatment on Pain Perception and on the Ability to Cope With Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: pain
acupuncture
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Assaf-Harofeh Medical Center
First posted: 2006-08-30
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 41 consequtive patients with chronic musculosckeletal pain

Brief summary: The Purpose of this study is to evaluate whether cognitive and emotional components take part in the positive acupuncture effect on pain.

Detailed description: The effect of acupuncture on pain intensity has been already investigated and confirmed. Recent publication (Pariente J., et a., 2005) indicated that acupuncture may affect midbrain areas, that are associated with cognitive control of pain.

The Pain Self Regulation Model (Levental, 1980)distinguishes between emotional response pain representations and cognitive pain representations. According to this model, emotional and cognitive pain representations leads to a new (cognitive or emotional) evaluation of the pain, that affects its perception and the ability to cope with it (Levental at al., 2001).

This study will try to assess the hypothesis that acupuncture treatment is involved in this process.

The study is designed as pilot study, limited to 45 patients.

Eligibility criteria: Inclusion Criteria:

* patients suffering from pain,who are reffered for acupuncture treatment,and consented to participate in this study

Exclusion Criteria:

* children under 18 years of age

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Hospital,
Study officials:
affiliation: Sheba Hospital, Tel Hashomer, ISRAEL
name: Dorit Gamus, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01051102: Effect of NN5401 in Japanese Subjects With Type 1 Diabetes
Official title: A Trial Investigating the Pharmacodynamic Properties of NN5401 in Japanese Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-01-18
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Japan. The aim of this clinical trial is to investigate the blood sugar lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in Japanese subjects with type 1 diabetes. Each subject will be randomised to one of the two possible treatment sequences (NN5401 followed by biphasic insulin aspart (BIAsp) 30 or biphasic insulin aspart 30 followed by NN5401).


Eligibility criteria: Inclusion Criteria:

* Japanese subject
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index (BMI): 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Loss of more than 400 mL blood (inclusive) in total with in the last 12 weeks or more than 200 mL blood (inclusive) in total within the last 4 weeks prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes (not inclusive 5) or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Primary outcomes:
measure: Area under the Glucose Infusion Rate curve after a single dose
timeFrame: From 4-12 hours
Secondary outcomes:
measure: Area under the insulin aspart concentration-time curve after a single dose
timeFrame: From 0-12 hours
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Ikushima I, Hirao K, Sasaki T, Fumiaki K, Clauson P, Roepstorff C, Haahr HL. Glucose lowering effect of IDegAsp in Japanese subjects with type 1 diabetes. 56th Annual Meeting of the Japan Diabetes Society (JDS) 2013; Country: Japan City: Kumamoto
Clinical trial NCT03841721: Linezolid in Healthy Volunteers
Official title: Pharmacokinetics/Pharmacodynamics of Oral Linezolid 300 mg/Day in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetic
linezolid
healthy volunteers
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Linezolid is the first synthetic antibiotic of oxazolidinone group that can inhibit bacterial protein synthesis. Previous studies have found that linezolid was an effective treatment for multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB). In addition, the current dosage recommendation (1,200 mg/day) occasionally resulted in serious adverse events including bone marrow suppression and peripheral neuropathy.

The objective study were determine the pharmacokinetics of oral linezolid 300 mg /day in healthy volunteers. This study conducted in six healthy volunteers. All subject received an oral linezolid 300 mg/day by directly observed treatment (DOT) at the same time each day for 5 days. Blood samples were collected on day 5 at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 h post dosing. The separated plasma samples were evaluated by ultra-performance liquid chromatography (UPLC). All pharmacokinetic parameters were calculated.


Eligibility criteria: Inclusion Criteria:

* Age 20 - 40
* BMI 19 - 24 kg/m2
* normal CLcr
* normal liver function

Exclusion Criteria:

* Subject who pregnant
* Subject who have documented hypersensitivity to linezolid

Primary outcomes:
measure: Concentration of linezolid in plasma
timeFrame: 24 hour after the linezolid dose
Secondary outcomes:
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
state: Songkla
Study officials:
References:
Clinical trial NCT03713021: TraceIT Tissue Marker to Mark the Primary Resection Bed Margins of Oropharyngeal Cancers
Official title: Evaluation of TraceIT Tissue Marker to Mark the Primary Resection Bed Margins of Oropharyngeal Cancers: a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Oropharyngeal Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research study is to look at how using an injectable marker called TraceIT can help with the radiation treatment planning process. TraceIT is a gel that dissolves in the body over time and can be injected and is visible on many types of images that can be used in the treatment planning process. If the exact edges of negative tumor margins can be marked before treatment planning, it is thought that the area receiving radiation can be more personalized, thus potentially reducing unnecessary radiation to areas that are cancer-free.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed (by routine H\&E staining) or highly suspicious for oropharyngeal squamous cell cancer.
* Planned treatment includes transoral surgery followed by adjuvant intensity modulated radiation therapy (IMRT).
* At least 18 years of age.
* Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria:

* Distant metastatic disease at the time of definitive treatment, and thus study, initiation.
* History of major head \& neck surgery or previous head \& neck irradiation.
* History of or current oral disease that may interfere with interpretation of study outcomes.
* Currently enrolled in another radiation therapy trial that has not completed its primary endpoint or that clinically interferes with this study.
* Poor surgical candidate
* Prisoners

Primary outcomes:
measure: Percent Change in Total Mean Clinical Target Volumes (CTV) Between the Standard of Care Treatment Plan and the Treatment Plan Based on the TraceIT Hydrogel Markers
timeFrame: At the treatment planning (2-5 weeks after TraceIT hydrogel placement)
Secondary outcomes:
measure: Percentage of Participants Experiencing an Adverse Event Related to TraceIT Injection
timeFrame: From time of injection through surgery (day 1)
measure: Anatomic Localization Related to Standard Treatment Fields Based on Anatomy as Measured by Number of Participants That Had Markers Visible
timeFrame: At the treatment planning (2-5 weeks after TraceIT hydrogel placement)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ryan S Jackson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05215821: Insulin Resistance and Severity of Coronary Artery Disease
Official title: HOMA Estimated Insulin Resistance as a Marker for Angiographic Severity of Coronary Artery Disease in Non Diabetic & Non Obese Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Insulin Resistance
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing coronary angiography due to suspected coronary artery disease

Brief summary: this is an observertional study aimed at Study the association between Insulin resistance estimated by HOMA and Angiographic Severity of Coronary Artery Disease in Non Diabetic \& Non Obese Patients.


Eligibility criteria: Inclusion Criteria:

* patients undergoing coronary angiography (CA) for ACS or stable angina in the Catheterization Laboratory of internal Medicine department and El Noor specialized cardiac center at the study period.

Exclusion Criteria:

* age \< 18 years,
* pregnancy or breastfeeding,
* BMI \>30 Kg/m2 and
* presence of pre-diabetes or overt diabetes.

Primary outcomes:
measure: HOMA IR level estimated by Two-site immunoenzymometric assay
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag uniersity hosoital
Study officials:
affiliation: Sohag faculty of medicine
name: Ali mo Altaher, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06190821: Hydrodissection of the Hepatoduodenal Ligament
Official title: Hydrodissection of the Hepatoduodenal Ligament
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatic Lesions
Keywords: hepatic lesions
liver lesions
duodenum
hepato duodenal ligament
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject (≥18 years of age) who underwent percutaneous ablation of primary or secondary liver lesions at HUS that required per-procedure hepatoduodenal ligament hydrodissection in the interventional imaging department of the New Civil Hospital from January 2019 to July 2022.

Brief summary: Percutaneous treatment of liver lesions adjacent to the duodenum exposes the duodenum to the risk of thermal injury, limiting removal and oncologic outcome. In this study the investigators investigate the feasibility of hepato duodenal ligament dissection in the percutaneous treatment of liver lesions adjacent to the duodenum.


Eligibility criteria: Inclusion criteria:

* Major subject (≥18 years of age)
* Subject who underwent percutaneous ablation of primary or secondary liver lesions at HUS that required per-procedure hepatoduodenal ligament hydrodissection in the interventional imaging department of the New Civil Hospital from January 2019 to July 2022.
* Subject who has not expressed opposition to the reuse of their data for the purpose of this research.

Exclusion Criteria:

- Opposition to the reuse of his/her data for the purpose of scientific research.

Primary outcomes:
measure: Retrospective description of the hepatoduodenal ligament dissection in the percutaneous treatment of liver lesions adjacent to the duodenum
timeFrame: Files analysed retrospectively from January 01, 2019 to July 31, 2022 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Imagerie interventionnelle oncologique et viscérale - CHU de Strasbourg - France
Study officials:
References: