louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00874653: Survey on Patient Satisfaction Rate for Mirena Use in Heavy Menstrual Bleeding
Official title: Levonorgestrel Releasing Intrauterine System (MIRENA) in Idiopathic Menorrhagia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menorrhagia
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-04-02
Enrollment: 78
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with a diagnosis of idiopathic menorrhagia and Mirena inserted for a period no longer than three months according to the assessment of the investigator will be included in the study

Brief summary: The purposes of this study are:

* To evaluate patient satisfaction for efficacy and tolerability of heavy menstrual bleeding treatment by Mirena.
* To collect italian data for Mirena in clinical routine.


Eligibility criteria: Inclusion Criteria:

* Women diagnosed with Idiopathic Menorrhagia and Mirena inserted for a period no longer than three months according to the assessment of the investigator and according to the international and national guidelines. These women should also accept to be on contraception during the time period that they have Mirena in situ
* Body Mass Index = 18-30

Exclusion Criteria:

* One or more of the following disorders: Current or recurrent pelvic inflammatory disease; infection of the lower genital tract; postpartum endometritis; septic abortion during the past three months; cervicitis; cervical dysplasia; uterine or cervical malignancy; undiagnosed abnormal uterine bleeding; congenital or acquired abnormality of the uterus including fibroids if they distort the uterine cavity; conditions associated with increased susceptibility to infections; acute liver disease or liver tumor; known hypersensitivity to any of the constituents of the product
* Nulliparity
* Consumption of Iron, Antiprostaglandins, hormonal drugs and any medication that could effect bleeding should be stopped at least 3 months before the first visit and should not be used during the course of the study.
* History of diabetes mellitus, cardiovascular disease and thyroid abnormalities
* Anticoagulation therapy
* Cancer history including breast cancer

Primary outcomes:
measure: The quality of life on the basis of the validated Health-Related Quality of Life questionnaire (HRQL SF-36)
timeFrame: at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Many Locations
country: Italy
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06777953: Regional Anesthesia for Lower Extremity Surgery
Official title: Comparative Efficacy of Popliteal Sciatic Nerve and Lumbar Sacral Erector Spinae Plane Blocks for Postoperative Analgesia in Tibia Fractures: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erector Spinae Plane Block
Lower Extremity Surgery
Sciatic Nerve Block
Keywords: sacral erector spinae plane block
lower extremity surgery
lumbar erector spinae plane block
sciatic nerve block
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with proximal tibial fractures who underwent surgery within the past year at the orthopedic clinic.

Brief summary: In this study, patients who underwent osteosynthesis with plate via standard anterolateral incision due to proximal tibia fracture in the orthopedic clinic within the last year; those who underwent perioperative anesthesia with spinal block, those who underwent postoperative analgesia with Ultrasound-guided popliteal sciatic nerve block, lumbar-sacral Erector Spine plane block combinations in the recovery unit will be identified and their files will be scanned retrospectively. Gender, surgical duration, postoperative block, pre-post block pain levels will be reviewed via Visual Analog Scale scoring, postoperative analgesics consumed and their amounts, Bromage scale, mobilization times, block-related complications, satisfaction levels will be determined and these two groups of patients who underwent block will be compared in terms of analgesia, complications, and satisfaction.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-65
* Patients undergoing spinal anesthesia
* Patients undergoing postoperative erector spinae plane block
* Patients undergoing postoperative sciatic nerve block

Exclusion Criteria:

* Pregnant patients
* Patients who cannot be contacted
* Patients who have undergone perioperative general anesthesia
* Patients with a history of cerebrovascular disease
* Patients with data loss
* Patients who did not receive consent

Primary outcomes:
measure: Postoperative Analgesia
timeFrame: 24 hours
Secondary outcomes:
measure: Block related complication
timeFrame: 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haseki Training and Research Hospital
Study officials:
affiliation: Haseki Training and Research Hospital
name: Munevver Kayhan, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02495753: Vaginal Cleansing Before Cesarean Delivery to Reduce Infection
Official title: Vaginal Cleansing Before Cesarean Delivery to Reduce Infection: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications; Cesarean Section
Keywords: cesarean section
wound infection
vaginal cleansing
endometritis
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-07-13
Enrollment: 608
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity.

Detailed description: Cesarean delivery is the most common surgical procedure performed on women in the US; nearly 1.3 million are performed each year. Postoperative infectious morbidity is the most common complication of cesarean delivery. Post-cesarean infectious morbidity is often the result of indigenous vaginal flora that ascend into the uterus at the time of surgery. Thus, reducing vaginal microbial load may reduce post-cesarean infection. However, results from studies assessing the role of vaginal cleansing prior to cesarean have been mixed.

The investigators will perform a randomized controlled clinical trial to test the hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity.

Eligibility criteria: Inclusion Criteria:

* Women undergoing cesarean delivery after labor at Barnes-Jewish Hospital.

Exclusion Criteria:

* Inability to obtain consent
* known or suspected allergy to iodine or shellfish
* women with active herpes simplex virus infection

Primary outcomes:
measure: Composite Postoperative Infectious Morbidity
timeFrame: 30 days postoperatively
Secondary outcomes:
measure: Adverse Reaction to Vaginal Cleansing
timeFrame: 30 days postoperatively
measure: Length of Hospital Stay
timeFrame: 30 days postoperatively
measure: Number of readmissions to hospital for infectious morbidity.
timeFrame: 30 days postoperatively
measure: Treatment for neonatal Sepsis
timeFrame: 30 days postoperatively
measure: Number of outpatient visits for infectious morbidiy.
timeFrame: 30 days postoperatively.
Other outcomes:
measure: Prespecified Stratified Analysis for Subgroups
timeFrame: 30 days postoperatively
measure: Prespecified Stratified Analysis for Subgroups
timeFrame: 30 days postoperatively
Locations:
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
Study officials:
References:
citation: Haas DM, Morgan S, Contreras K, Kimball S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2020 Apr 26;4(4):CD007892. doi: 10.1002/14651858.CD007892.pub7.
Clinical trial NCT04337853: Radiotherapy of Tongue Cancer Using an Intraoral Stent
Official title: Implementation of an Intraoral Stent in Radiotherapy of Tongue Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tongue Cancer
Keywords: Radiotherapy
Head and neck cancer
Intraoral stent
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Oslo Metropolitan University
First posted: 2020-04-08
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Radiotherapy of tongue cancer is associated with acute and late morbidity. Use of an intraoral stent will provide a larger distance between the tongue and palate and can reduce side-effects. The aim of the present study is to confirm that an intraoral stent will give lower dose to the palate throughout the treatment period.

Detailed description: Radiotherapy of tongue cancer is associated with acute and late morbidity. Use of an intraoral stent will provide a larger distance between the tongue and palate and can reduce side-effects. The main objective of the present study is to confirm that the use of an intraoral stent will result in lower dose to the palate throughout the treatment period. A secondary objective is to measure the reduction in acute mucositis in the palate.

The intraoral stent used in the present study is available in two sizes, 10 and 20mm thickness. The intervention group and control group will consist of approximately five patients each. Target coverage will be measured by the minimum dose covering 98% of the clinical target volume (D98CTV). Dose to the organs at risk (hard and soft palate) will be measured by the mean dose. Data will be collected from the planning computed tomography (CT) and daily cone-beam CT (CBCT). Acute mucositis will be scored by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.

Eligibility criteria: Inclusion Criteria:

* Patients with tongue cancer
* Curatively intended radiotherapy requiring a total dose of 50-70 Gy
* Age \>18 years
* Performance status, Eastern Cooperative Oncology Group (ECOG) 0-2

Exclusion Criteria:

None

Primary outcomes:
measure: Reduction in mean dose to the hard palate
timeFrame: At the end of radiotherapy (5-6 weeks)
Secondary outcomes:
measure: Reduction in mean dose to the soft palate
timeFrame: At the end of radiotherapy (5-6 weeks)
measure: Reduction in acute mucositis in the hard palate
timeFrame: At the end of radiotherapy (5-6 weeks)
measure: Reduction in acute mucositis in the soft palate
timeFrame: At the end of radiotherapy (5-6 weeks)
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital, Department of Oncology
name: Einar Dale, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02519751: New Method Using Deuterium Labelled Creatine to Measure Total Body Skeletal Muscle Mass
Official title: Total Body Skeletal Muscle Mass Estimation by Creatine (Methyl-d3) Dilution in Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Nutritional Sciences
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-08-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Creatine (methyl-d3) dilution (D3-creatine) is a novel technique for the estimation of muscle mass. The method uses a dose of deuterium-labelled creatine to determine total skeletal muscle mass via estimation of total body creatine pool size.The aim of this study is to compare estimates of total body skeletal muscle mass by D3-creatine dilution method and whole body Magnetic Resonance Imaging (MRI) in an athletic population.


Eligibility criteria: Inclusion Criteria:

* Trained and competing elite canoe athletes will be recruited, who represent Great Britain Canoeing

Exclusion Criteria:

* Pregnant and lactating women
* Intolerance or hypersensitivity to Creatine supplementation
* Athletes with disabilities which affect their total body muscle mass
* If creatine was taken in a supplemented form, rather than dietary intake, more regularly than once a week within 6-weeks of assessment commencing
* Contraindication to an MRI scan

Primary outcomes:
measure: Correlation between muscle mass obtained by MRI method and D3-Creatine method
timeFrame: Upto 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brentford
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02896153: Current Situation on the Consumption of Hypnotic Substances at the Pharmacy
Official title: Current Situation on the Consumption of Hypnotic Substances at the Pharmacy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Substances Used for a Hypnotic Purpose
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 657
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult going to a pharmacy

Brief summary: In France, consumption of hypnotic drugs is high. In this context, and given the planned regulatory modifications, it seems essential to make an inventory of the consumption of drugs taken for a hypnotic purpose. This study aims to identify the substances (medical or not) used for a hypnotic purpose in the adult population going to a pharmacy.


Eligibility criteria: Inclusion Criteria:

* Adult going to the pharmacy and who accepts to complete the questionnaire

Exclusion Criteria:

* Minor
* Who is not able to complete a questionnaire
* Who does not accept to complete the questionnaire

Primary outcomes:
measure: The name of the substance (medical or not) used for a hypnotic purpose
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02829151: Comparison of Cilostazol-based Triple Antiplatelet Therapy Versus Dual Antiplatelet Therapy for Outcomes of below-the Knee Endovascular Intervention in Patients With Critical Limb Ischemia (TAP CLI Study)
Official title: Comparison of Cilostazol-based Triple Antiplatelet Therapy Versus Dual Antiplatelet Therapy for Outcomes of below-the Knee Endovascular Intervention in Patients With Critical Limb Ischemia (TAP CLI Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Critical Limb Ischemia
Keywords: Peripheral artery disease
Critical limb ischemia
Angioplasty
Antiplatelet therapy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 390
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * Prospective, randomized, controlled, multi-center study
* A total of 390 subjects with critical limb ischemia will be included according to inclusion and exclusion criteria.
* Patients will be randomized in a 1:1:1 manner into triple antiplatelet therapy (TAP: aspirin, clopidogrel, cilostazol) group, dual antiplatelet therapy (DAP: aspirin, clopidogrel) A group, or DAP (aspirin, cilostazol) B group.
* All patients will be treated with angioplasty for critical limb ischemia.
* Patients will be followed clinically for 1 year after the procedure.
* Ankle-brachial index and Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 19 years old
* Patients with critical limb ischemia (Rutherford 4 \& 5)
* Successful below-the knee endovascular intervention.

Exclusion Criteria:

* Major bleeding event within recent 3 months or high risk of major bleeding
* Patients requiring anticoagulation
* Allergic reactions to antiplatelet drugs
* Acute limb ischemia
* Severe hepatic dysfunction (3 times normal reference values)
* Pregnant women or women with potential childbearing
* Life expectancy \< 1 year due to comorbidity
* Previous amputations in the target limb

Primary outcomes:
measure: Major adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Major adverse event between TAP group and DAP B group
timeFrame: 12 months
measure: Adverse limb event among the 3 patient groups
timeFrame: 12 months
measure: Bleeding complications among the patient groups
timeFrame: 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Department of Internal Medicine, Severance Hospital
Study officials:
References:
Clinical trial NCT05667051: Endocan Biomarker Level in Gingival Crevicular Fluid in Periodontitis Patients With Type 2 Diabetes Mellitus
Official title: Endocan Biomarker Level in Gingival Crevicular Fluid in Periodontitis Patients With Type 2 Diabetes Mellitus [A Comparative Cross-Sectional Study]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Diabetes Mellitus
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage 1 or 2 (mild to moderate) periodontitis having ≤ 4 mm attachment loss at least in one site were included in the study these were divided into two groups, with controlled type 2 diabetes mellitus, and systemically healthy stage 1 or 2 (mild to moderate) periodontitis patients

Brief summary: Aim of the current study was to evaluate Endocan biomarker level in gingival crevicular fluid of patients with stage 1 or 2 (mild to moderate) periodontitis with controlled type 2 diabetes mellitus (DM) and compare it to that in DM free periodontitis patients.


Eligibility criteria: Inclusion Criteria:

* Probing pocket depths (PPD) ≤ 5 mm.
* Clinical attachment level (CAL) ≤ 4 mm.
* Type 2 DM, for at least the past 3 years.
* HbA1c ≤ 7%.

Exclusion Criteria:

* Uncontrolled Diabetes Mellitus.
* Systemic antibiotic or anti-inflammatory medication use in the previous 2 months.
* Non-surgical periodontal therapy in the previous 6 months.
* Surgical periodontal therapy in the previous 12 months.
* Use of calcium channel blockers, phenytoin, or cyclosporine.
* Pregnancy.
* Smokers

Primary outcomes:
measure: Endocan level
timeFrame: Day 1
measure: Pocket probing depth (PPD)
timeFrame: Day 1
measure: Clinical Attachment Level (CAL)
timeFrame: Day 1
measure: Percentage of bleeding on probing sites (BOP%)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Emad Ayyad, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Maha Abou Khadr, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Mona Ayyad, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Gillan El-Kimary, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04864951: HPV Prevalence in Transpersons - a Prospective Study
Official title: HPV Prevalence in Transpersons - a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Papillomavirus Infection
Transsexualism
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: In this study, Human Papilloma Virus (HPV) prevalence will be determined once in the urine of 200 trans people. In addition, subjects will be asked to complete a questionnaire about their sexual orientation, which is adapted from the largest published study.

Detailed description: All transpeople who visit the outpatient clinic are asked to participate in the study. After being informed and signing the Informed Consent Form, the subjects are asked to give first-void urine and fill out the survey. The urine samples are sent pseudonymously to the University of Ljubljana for analysis. The subjects will be informed about their results within 3 weeks.If the result is positive, the subjects will be offered voluntary further care in our HPV outpatient clinic. However, this will take place outside the study. The data collected there can be used for further analyses.

Eligibility criteria: Inclusion Criteria:

* Transpeople
* Age over 18 years
* Sufficient knowledge of German

Exclusion Criteria:

* Age under 18 years
* Insufficient knowledge of German

Primary outcomes:
measure: HPV prevalence in transpeople
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Ljubljana
country: Slovenia
facility: Institute of Microbiology and Immunology Faculty of Medicine
Study officials:
affiliation: Medical University of Vienna, Department of Obstetrics and Gynecology
name: Elmar Joura, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reisner SL, Deutsch MB, Peitzmeier SM, White Hughto JM, Cavanaugh TP, Pardee DJ, McLean SA, Panther LA, Gelman M, Mimiaga MJ, Potter JE. Test performance and acceptability of self- versus provider-collected swabs for high-risk HPV DNA testing in female-to-male trans masculine patients. PLoS One. 2018 Mar 14;13(3):e0190172. doi: 10.1371/journal.pone.0190172. eCollection 2018.
citation: Pils S, Mlakar J, Poljak M, Domjanic GG, Kaufmann U, Springer S, Salat A, Langthaler E, Joura EA. HPV screening in the urine of transpeople - A prevalence study. EClinicalMedicine. 2022 Oct 12;54:101702. doi: 10.1016/j.eclinm.2022.101702. eCollection 2022 Dec.