louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06212739: Post-op Pain After Fistula Laser Closure or Ligation of the Intersphincteric Tract for Anal Fistula
Official title: Comparison of Post-operative Pain Between Fistula Laser Closure and Ligation of the Intersphincteric Tract in the Treatment of Anal Fistula - a Randomized Controlled Trial. (LASERLIFT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fistula in Ano
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This is a prospective, double-blinded randomised controlled trial conducted at two tertiary hospitals by a credentialed colorectal surgeon.

Detailed description: Patients with high transphincteric fistulas were blinded and randomized to either laser or ligation of the fistula tract (LIFT). Pain scores at rest and movement, at 6 and 24 hours post operatively were measured using the visual analogue scale (VAS). Operative time was measured in minutes Continence and quality of life was assessed via the Wexner incontinence scale and SF-36 questionnaire respectively at 0, 3 and 6 months post-operatively.

Eligibility criteria: Inclusion Criteria:

* Complex transphincteric fistulas:
* high transphincteric fistula, involving more than 30% of the external anal sphincter
* Multiple fistulas
* Anterior fistulas
* 18-75 years old
* Able to give consent
* New or recurrent fistulas
* Fistulas with or without setons

Exclusion Criteria:

* Active perianal sepsis requiring drainage
* Fistulas of non-cryptogladular origin- Crohn's, TB, malignancy
* Expected lifespan less than 6 months
* Pregnant women
* Patients with more than 1 definitive surgery done for the fistula before
* Patients with human immunodeficiency virus infection
* Patients with pre-existing chronic pain disorders
* Patients with Non-steroidal Anti-inflammatory Drug (NSAIDS) / Paracetamol allergies

Primary outcomes:
measure: Post-operative pain score
timeFrame: 6 hours, 24 hours
Secondary outcomes:
measure: Operative time
timeFrame: Intraoperative
measure: Continence
timeFrame: At baseline, and at 1 week, 1 month and 6 months post-operatively
measure: SF36
timeFrame: At baseline, and at 1 week, 1 month and 6 months post-operatively
measure: Return to work
timeFrame: Number of days taken to return to work, assessed at 6 months post-operatively
measure: Duration of analgesia use
timeFrame: Number of days until cessation of analgesia use, assessed at 1 week or 1 month, whichever is shorter
measure: Failure rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: Federal Territory
Study officials:
affiliation: Universiti Malaya
name: April C Roslani, MS, FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00630539: A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women
Official title: Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A Phase II Dose Ranging, 12-Week, Randomized , Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 5 mg, 15 mg and 30 mg Daily Doses With Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrophy
Vaginal Diseases
Keywords: Menopausal symptoms
Urogenital atrophy
Vulvar and vaginal atrophy in postmenopausal women
Vaginal atrophy
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hormos Medical
name: QuatRx Pharmaceuticals
First posted: 2008-03-07
Enrollment: 126
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg tested earlier in Phase II.


Eligibility criteria: Inclusion Criteria:

* Naturally or surgically menopausal
* Vaginal pH greater than 5.0
* 5% or fewer superficial cells in maturation index of vaginal smear

Exclusion Criteria:

* Evidence of endometrial hyperplasia, cancer or other pathology
* Abnormal PAP smear
* Uterine bleeding of unknown origin or uterine polyps
* Current vaginal infection requiring medication
* Use of hormonal medications
* Clinically significant abnormal gynecological findings other than signs of vaginal atrophy

Primary outcomes:
measure: Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
timeFrame: 12 weeks
measure: Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear
timeFrame: 12 weeks
measure: Mean Change From Baseline in Vaginal pH
timeFrame: 12 weeks
Secondary outcomes:
measure: Visual Evaluation of Vagina (by Gynecological Examination)
timeFrame: Screening & Week 12
measure: Mean Change From Baseline in Vaginal pH
timeFrame: Week 4
measure: Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index
timeFrame: Week 4
measure: Mean Change From Baseline in Estradiol Levels
timeFrame: Week 12
measure: Mean Change From Baseline in Luteinizing Hormone Levels
timeFrame: Week 12
measure: Mean Change From Baseline in Follicle Stimulating Hormone Levels
timeFrame: Week 12
measure: Mean Change From Baseline in Sex Hormone Binding Globulin Levels
timeFrame: Week 12
measure: Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index
timeFrame: Week 4
Other outcomes:
Locations:
Study officials:
affiliation: Shionogi
name: Shionogi Clinical Trials Administrator Clinical Support Help Line
role: STUDY_DIRECTOR
References:
Clinical trial NCT02334839: The Association Between Severity of Hypertensive Disorder During Pregnancy and Endothelial Dysfunction
Official title: The Association Between Severity of Hypertensive Disorder During Pregnancy and Endothelial Dysfunction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endothelial Dysfunction
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2015-01-08
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A prospective cohort study of approximately 150 gravidas who are hospitalized in maternal-fetal medicine (MFM) ward in Rabin Medical Center in Israel.

Brief summary: Preeclampsia toxemia (PET) is a pregnancy related complication that is usually expressed as new onset hypertension and proteinuria after 20 weeks of gestation. scarce data exists regarding the effectiveness of PAT plethysmography use in women with PET and whether adverse results are found compared to healthy gravidas. Thus, we aimed to assess endothelial function using PAT plethysmography in women with PET and compare their results to both healthy gravidas and those with only gestational hypertension.

.

Detailed description: Preeclampsia toxemia (PET) is a pregnancy related complication that is usually expressed as new onset hypertension and proteinuria after 20 weeks of gestation. Although the exact pathophysiology is unclear, it's related to abnormal placentation and subsequent vascular pathology. Endothelial dysfunction was found to play a significant role in the risk of cardiovascular event in general. Moreover, few studies found a relation between endothelial dysfunction and PET. There are several methods for the assessment of endothelial function, with Peripheral Artery Tone (PAT) plethysmography being an emerging non-invasive promising technique. However, scarce data exists regarding the effectiveness of PAT plethysmography use in women with PET and whether adverse results are found compared to healthy gravidas.

Thus, we aimed to assess endothelial function using PAT plethysmography in women with PET and compare their results to both healthy gravidas and those with only gestational hypertension.

Eligibility criteria: Inclusion Criteria:

1. Maternal age 18-40 years old
2. 27 and above weeks of gestation
3. Singleton pregnancy
4. Agreed to participate in the study and signed on informed consent form.

Exclusion Criteria:

1. Known ischemic heart disease or angina pectoris
2. Active smoker
3. Dyslipidemia, chronic hypertension. Renal disease, diabetes mellitus (gestational or pregestational)
4. Active treatment with anti-hypertensive medication, anti-aggregation medication or lipid lowering agents.

Primary outcomes:
measure: Reactive Hyperemia Index (RHI)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tiqwa
country: Israel
facility: Rabin medical center
Study officials:
affiliation: Rabin Medical Center
name: Liran Hiersch
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01326039: Ultrasound-guided Ilioinguinal-iliohypogastric Block for Inguinal Hernia Repair
Official title: Does Ultrasound-guided Ilioinguinal-iliohypogastric Block Improve Postoperative Pain Outcome After Unilateral Inguinal Hernia Repair?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Inguinal Hernia
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2011-03-30
Enrollment: 60
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: To investigate whether ultrasound-guided perineural administration of 20 ml bupivacaine 5 mg/ml vs 20 ml isotonic saline at the ilioinguinal-iliohypogastric nerves have a clinically analgesic effect after unilateral open inguinal hernia repair.


Eligibility criteria: Inclusion Criteria:

* age above 18 years
* unilateral primary inguinal repair
* open surgery a.m. Lichtenstein
* informed consent

Exclusion Criteria:

* age below 18 years
* secondary surgery
* laparoscopic surgery
* lack of communicative skills

Primary outcomes:
measure: pain at mobilization using 100 mm VAS
timeFrame: within the first 24 hours postoperatively
Secondary outcomes:
measure: pain at rest using 100 mm VAS
timeFrame: within 24 hours postoperatively
measure: perceived illness
timeFrame: within 24 hours postoperatively
measure: ability of daily living
timeFrame: within 24 hours
measure: amount of analgesics
timeFrame: within 24 hours postoperatively
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital Bispebjerg
state: NV
Study officials:
affiliation: Copenhagen University Hospital Bispebjerg, Denmark
name: Kenneth Jensen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01628939: Association Between Clinical Signs and MRI Findings of the Lumbar Facet Joints
Official title: Association Between Clinical Signs Assessed by Manual Segmental Examination and Findings of the Lumbar Facet Joints in Magnetic-resonance Scans in Subjects With and Without Current Low Back - a Prospective Single-blinded Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Facet Joint Pain
Keywords: low back pain
facet joint pain
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2012-06-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pain clinic, sports clubs and fitness centers

Brief summary: The purpose of this study is to determine

1. the prevalence of lumbar facet joint pain detected by manual segmental provocation tests
2. the prevalence of MRI findings of the lumbar facet joints (hypertrophy, effusion, edema)
3. the association of lumbar facet joint pain and MRI findings on a segmental level

in subjects with current low back pain and in a control group.


Eligibility criteria: Inclusion Criteria for both study groups:

* age \> 18
* written informed consent
* ability to perform required examinations

Inclusion Criterion for current low back pain-group:

- more than (\>=) 30 days of low back pain in the last three months

Inclusion Criterion for control group:

- less than 30 days of low back pain in the last three months

Exclusion Criteria for both study groups:

* acute radicular low back pain in the last three months
* claustrophobia
* spondylodesis of the lumbar spine
* any metallic implants which are not MRI-compatible

Primary outcomes:
measure: Number of facet joints per person which show facet joint pain and FJ effusion and/ or edema
timeFrame: 2 hours
Secondary outcomes:
measure: number of painful facet joints per person
timeFrame: 2 hours
measure: number of facet joints diagnosed with facet joint effusion and/ or edema per person
timeFrame: 2 hours
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH
state: NRW
Study officials:
affiliation: Head of the Department of Pain medicine, BG Universitätsklinikum Bergmannsheil GmbH, 44789 Bochum, Germany
name: Christoph Maier, M.D., PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02031939: Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer
Official title: Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Advanced Rectal Cancer
Keywords: Rectal cancer
neoadjuvant chemoradiotherapy
optimization
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 556
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although neoadjuvant chemoradiotherapy has significantly reduced the risk of local recurrence in locally advanced rectal cancer, systemic failure remains a predominant issue probably due to the insufficient control of systemic micro-metastasis in the neoadjuvant treatment. Induction chemotherapy is one of the most studied strategies. However, the efficacy of induction chemotherapy prior to neoadjuvant chemotherapy remains controversial. In our previous study, induction chemotherapy, gap chemotherapy combined with neoadjuvant chemoradiotherapy can improve response rate of rectal cancer patients, but the results have not been confirmed in clinical trial. Whether this new kind of treatment can optimize neoadjuvant therapy for locally advanced rectal cancer or not is still a big problem in clinical practice. This study will focus on how to optimize neoadjuvant chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Pathological confirmed rectal cancer
* Clinical stage T3-4 or T any N1
* No metastasis
* Distance of tumor is no more than 10cm from anal verge
* No previous radiotherapy
* Age ranged from 18 to 70
* Eastern Cooperative Oncology Group score system 0-1

Exclusion Criteria:

* Clinical stage T1-2 N0
* Distance metastasis
* Multiple primary tumor
* Cachexy

Primary outcomes:
measure: overall survival
timeFrame: 5 years
Secondary outcomes:
measure: disease free survival
timeFrame: 3 years
measure: Disease free survival
timeFrame: 5 years
measure: Respond rate
timeFrame: One week after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Zhen-Hai Lu, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00695539: Rosuvastatin Efficacy and Safety Evaluation in Hypercholesterolaemic Patients
Official title: A Multi-centre, Open Label, Non-randomised, Non Interventional, 24 Weeks Study for the Efficacy and Safety of Rosuvastatin Following Its Administration in Real Life Clinical Practice in Greek Hypercholesterolaemic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolaemia
Keywords: Rosuvastatin
hypercholesterolaemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-12
Enrollment: 810
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care

Brief summary: This is a single-arm, phase IV, open-label, prospective, non interventional study to evaluate the efficacy, tolerability and safety of rosuvastatin administered for 24 weeks in approximately 900 Greek subjects with hypercholesterolemia under normal clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patients with hypercholesterolaemia who are already in treatment with rosuvastatin according to the approved SPC for no longer than 1 month prior to study entry
* Patients that are able to read, understand and sign the Patient Information \& Consent Form
* Patients that are willing to comply with all study requirements

Exclusion Criteria:

* Patients that are likely not to comply with all study requirements
* Patients that currently participate or have participated in a 3 months period prior to study entry in another clinical trial
* Female of child bearing potential that do not use a reliable method of contraception. Pregnancy or lactation.
* Patients that meet any of the contraindications described in the approved SPC

Primary outcomes:
measure: The assessment of rosuvastatin efficacy in the reduction of low-density lipoprotein cholesterol (LDL-C) in subjects with hypercholesterolemia at week 12 of treatment compared with baseline
timeFrame: At 12 weeks of treatment
measure: To evaluate the percentage of patients on European LDL-C target at week 12
timeFrame: At 12 weeks of treatment
Secondary outcomes:
measure: Changes in HDL-C, TC and TG
timeFrame: At week 12 & 24 of treatment
measure: Safety and tolerability
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Alexandroupoli
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Iraklio, Crete
country: Greece
facility: Research Site
city: Larissa
country: Greece
facility: Research Site
city: Rio, Patra
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
Study officials:
References:
Clinical trial NCT00676039: Comparison of the Pharmacokinetics of Two Generic Antidepressants and Their Respective Brand Preparations
Official title: Examination of the Pharmacokinetic Properties of Two Generic Antidepressants and Their Respective Brand Preparations in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Therapeutic Equivalency
Human Experimentation
Bioequivalence
Brand name
Generic
Antidepressant
Healthy volunteers
Lead sponsor: University of Ottawa
Sponsor class: OTHER
First posted: 2008-05-12
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Generic medications should be the equivalent of brand medications with the exception of their price. Before a generic medication is introduced, its bioequivalence within a window of 80 to 125% of the original has to be demonstrated. There are reports that this criterion is not always followed in post-marketed periods. Such investigations were triggered by the observation that some patients previously stable on original medications relapsed when switched to a presumable equivalent generic. Several factors could account for this problem. Given reports of such problems occurring with the antidepressants citalopram and venlafaxine, some pharmacokinetic properties of specific brands of generics and the originals will be examined for these two medications. Twelve healthy male volunteers will participate in this crossover study. It is anticipated that there will be significant differences emerging between the two formulations given the clinical reports of patients deteriorating when switched from the original to the generic preparations.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers (absence of diseases: psychiatric, physical, neurological, metabolic,...)

Exclusion Criteria:

* Psychiatric disorder
* Hepatic disease
* Renal disease
* Gastrointestinal disease
* Hematological disease
* Smokers
* Physical and/or neurological disease
* Positive urine drug screen
* Abnormal blood pressure
* Abnormal urine/blood analysis (sodium, potassium, chloride, creatinine, urea, ALT, AST, total protein, glucose, and TSH)

Primary outcomes:
measure: Blood levels of drugs and their metabolite (when appropriate) will be evaluated for both the generic and the brand name medication.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa, Institute of Mental Health Research
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Franck Chenu, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Chenu F, Batten LA, Zernig G, Ladstaetter E, Hebert C, Blier P. Comparison of pharmacokinetic profiles of brand-name and generic formulations of citalopram and venlafaxine: a crossover study. J Clin Psychiatry. 2009 Jul;70(7):958-66. doi: 10.4088/jcp.09m05315.