louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00533312: MK0524A Clinical Efficacy Study (0524A-026)(COMPLETED)
Official title: A Multicenter, Randomized, Double-Blinded, Parallel-Design Study to Evaluate the Lipid-Altering Efficacy of 2 Formulations of MK0524A Compared to NIASPAN (TM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-09-21
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to determine lipid changing effects of MK0524A when compared to niacin extended release (NIASPAN) and placebo.


Eligibility criteria: Inclusion Criteria:

* Patients must be between the ages of 18 and 70 years
* Female patients must be pre-menopausal women that have been surgically sterilized, not pregnant and/or not planning to become pregnant

Exclusion Criteria:

* Patient has a history of peptic ulcer or gout
* Patient is sensitive to niacin or products containing niacin
* Patient drinks more than 2 alcoholic drinks per day
* Patient has certain heart disease, cancer, or is HIV positive

Primary outcomes:
measure: To assess the HDL-C raising efficacy of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.
timeFrame: After 4 weeks
Secondary outcomes:
measure: To asses the triglyceride-lowering effects of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.
timeFrame: After 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Lai E, De Lepeleire I, Crumley TM, Liu F, Wenning LA, Michiels N, Vets E, O'Neill G, Wagner JA, Gottesdiener K. Suppression of niacin-induced vasodilation with an antagonist to prostaglandin D2 receptor subtype 1. Clin Pharmacol Ther. 2007 Jun;81(6):849-57. doi: 10.1038/sj.clpt.6100180. Epub 2007 Mar 28.
Clinical trial NCT01997112: PAracetamol Treatment in Hypertension: Effect on Blood Pressure (PATH-BP) Study
Official title: PAracetamol Treatment in Hypertension: Effect on Blood Pressure (PATH-BP) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Pressure
Keywords: Blood pressure
Hypertension
Paracetamol
Acetaminophen
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
name: National Health Service, United Kingdom
First posted: 2013-11-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to examine if chronic paracetamol dosing increases blood pressure in patients with known high blood pressure.

Detailed description: A prospective randomised, double-blind, crossover trial, comparing the effects of paracetamol 1g (500mg x2) four times daily with matched placebo on ambulatory and clinic BP, each given for 14 days, with a 14-day washout period.

Eligibility criteria: Inclusion Criteria:

* ≥18 years old, men or post-menopausal women (women with no periods for 12 months or more, or those who have had a surgical menopause)
* Treated hypertensive patients with an average daytime ambulatory blood pressure measurement (ABPM) \<150/95mmHg on stable doses of one or more antihypertensive medication (at least one of which should be; an ACE inhibitor, angiotensin receptor blocker or diuretic) for 3 months, or untreated hypertensive patients with an average daytime ABPM ≥135/85 but \<150/95.

Exclusion Criteria:

* History of ischaemic heart disease, cardiac failure, cerebrovascular disease, liver impairment (ALT/AST\>50IU/L) or stage 3-5 chronic kidney disease.
* History of overdose or suicidal ideation
* Patients weighing \<55kgs.
* Patients with chronic pain requiring treatment, with a known allergy to paracetamol, or concomitant use of non-steroidal anti-inflammatories , oral anticoagulants or corticosteroids.

Primary outcomes:
measure: Systolic ambulatory blood pressure
timeFrame: 14 days
Secondary outcomes:
measure: Systolic clinic blood pressure
timeFrame: 14 days
measure: Diastolic ambulatory blood pressure
timeFrame: 14 days
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Clinical Research Centre, Western General Hospital
state: City Of Edinburgh
Study officials:
References:
citation: MacIntyre IM, Turtle EJ, Farrah TE, Graham C, Dear JW, Webb DJ; PATH-BP (Paracetamol in Hypertension-Blood Pressure) Investigators*. Regular Acetaminophen Use and Blood Pressure in People With Hypertension: The PATH-BP Trial. Circulation. 2022 Feb 8;145(6):416-423. doi: 10.1161/CIRCULATIONAHA.121.056015. Epub 2022 Feb 7.
Clinical trial NCT03249012: Quality of Life Related to Different Treatment Protocols for Post-thyroidectomy Hypoparathyroidism
Official title: Comparing the Quality of Life Associated With Empiric Calcium Repletion and Parathormone (PTH) Based Calcium Repletion for Post Thyroidectomy Hypoparathyroidism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypoparathyroidism Postprocedural
Quality of Life
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare two different protocols commonly used in the management of post thyroidectomy hypoparathyroidism : PTH based calcium repletion and empiric repletion. The investigators aim to compare the quality of life associated with these two protocols in a randomized trial.

Detailed description: Enrolled patients will be randomized in two treatment groups. In group 1, all patients will receive calcium carbonate and calcitriol in the post-operative period, with standardized weaning. In group 2, patients will be prescribed calcium carbonate and calcitriol only if their post-operative PTH dosage is 25% or less of the pre-operative dosage, or if post-operative PTH is inferior to 15.

The Short-Form 36 (SF-36) questionnaire (French canadian version) will be used to assess quality of life pre-operatively and at post-op week 1 and 4. Symptoms of hypocalcemia and adverse effects of calcium carbonate and calcitriol will be monitored at week 1 and 4.

Eligibility criteria: Inclusion Criteria:

* Total thyroidectomy or completion hemithyroidectomy

Exclusion Criteria:

* Need for neck dissection
* Unable to fill in questionnaires (intellectual deficit, severe psychiatric disorder, illiterate, does not speak French or English)

Primary outcomes:
measure: Change from baseline quality of life at 1 and 4 weeks
timeFrame: Pre-op, 1 week post-op and 4 weeks post-op
Secondary outcomes:
measure: Occurence and change in pharmacologic adverse effects of calcium carbonate and calcitriol
timeFrame: 1 week post-op, 4 weeks post-op
measure: Occurence and change in symptoms of hypocalcemia
timeFrame: 1 week post-op, 4 weeks post-op
Other outcomes:
Locations:
city: Québec
country: Canada
facility: CHU de Quebec
state: Quebec
Study officials:
References:
Clinical trial NCT02829112: Shulman Fasciitis Prevalence Study in Alsace
Official title: Shulman Fasciitis Prevalence Study in Alsace
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shulman Fasciitis
Keywords: Shulman
fasciitis
Shulman fasciitis
eosinophilic fasciitis
inflammatory disease
prevalence
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 30
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: All patients suffering from fasciitis Shulmande and living in Alsace at 1 January 2016

Brief summary: Shulman fasciitis or eosinophilic fasciitis (EF) is a rare inflammatory disease, usually benign but disabling, described by Shulman in 1974. The diagnosis is suggested by the clinic, confirmed by MRI and confirmed by histology, there really no published diagnostic criteria validated for this rare disease. The low number of cases reported in the literature reflects the difficulty of studying the epidemiology of this disease, to establish and evaluate therapeutic strategies and to assess prognosis. Work on this subject are few. To our knowledge, no study has previously used to estimate the incidence and prevalence of this disease. Therefore, the investigators want to determine the prevalence of FEs in Alsace in 2016 by a study "capture-recapture" using several independent sources of identification of cases in order to have recent epidemiological data and learn more about this disease.


Eligibility criteria: Inclusion Criteria:

* Patients aged over 18 years
* Patients suffering from fasciitis Shulmande and living in Alsace at 1 January 2016

Exclusion Criteria:

* refusal to participate in the study

Primary outcomes:
measure: Estimation of the prevalence of Shulman fasciitis in Alsace, the calculation will be carried out using the numerator of all the cases identified and in the denominator the general population (Alsatian population of both sexes)
timeFrame: all living patients in Alsace from 1 January 2016 to december 2016
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de rhumatologie, Les Hôpitaux Universitaires de Strasbourg, Centre national de référence " des maladies auto-immunes rares "
Study officials:
References:
Clinical trial NCT06038812: Galectin Role in Periodontal Disease
Official title: Outcome of Non-surgical Periodontal Treatment on Gal-1 & Gal-3 GCF Levels in Periodontitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Periodontitis
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 45
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aimed at exploring the effect of nonsurgical periodontal treatment on galectin 1 and 3 GCF levels in patients having gingivitis, periodontitis stage III compared to periodontally healthy individuals and if galectin-1 and -3 could serve as diagnostic markers and/or therapeutic targets for periodontitis, in addition to revealing their possible role in the periodontal disease.

45 systemically healthy participants were enrolled in this investigation, equally subdivided into three groups of 15 patients each: gingivitis, periodontitis (stage III) and control group with healthy gingiva. Probing depth, clinical attachment level, gingival and plaque index were registered. GCF levels of galectin-1 and -3 were evaluated in all included groups (before and after non-surgical treatment for periodontitis group) using enzyme linked immune-sorbent assay (ELISA) kit.


Eligibility criteria: Inclusion Criteria:

1. Non-smokers from both genders.
2. Not suffering from systemic diseases, pregnancy/lactation.
3. Not taking contraceptive pills, antibiotics, anti-inflammatory, or immunosuppressive drugs before inclusion in the study by 6 months.
4. Patients with only gingivitis or periodontitis stage III.
5. Periodontitis patients who did not receive any professional periodontal treatment in the last 6 months.

Exclusion Criteria:

1. smokers.
2. having systemic diseases, pregnancy/lactation.
3. taking contraceptive pills, antibiotics, anti-inflammatory, or immunosuppressive drugs in the past 6 months.
4. Patients having periodontitis any other stage than stage III.
5. Periodontitis patients who receive any professional periodontal treatment in the last 6 months.

Primary outcomes:
measure: assessment of gal-1 and gal-3 in GCF samples
timeFrame: an average of about 10 months to assess level of gal-1 & -3 after collection of GCF samples at baseline (1st appointment) for all groups and another sample collection after 4 weeks for group II after performing scaling and root planning
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: faculty of dentistry, Fayoum university
Study officials:
References:
Clinical trial NCT05101512: Assessment of the Sub-gonal Arterial Revascularization of the Lower Limbs in Critical Ischemia by Venous Allograft Stored at + 4 ° C (ERAV)
Official title: Assessment of the Sub-gonal Arterial Revascularization of the Lower Limbs in Critical Ischemia by Venous Allograft Stored at + 4 ° C.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Allogeneic Transplant
Occlusive Peripheral Arterial Disease
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
name: Private Hospital Dijon
First posted: 2021-11-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to assess the 2-year survival with salvage of the lower limb of patients who have undergone subgonal bypass grafting by venous allograft in the treatment of Occlusive Peripheral Arterial Disease (OPAD) in critical ischemia, in the absence of usable great saphenous vein.


Eligibility criteria: Inclusion Criteria:

* Man or woman over 18 (under effective contraception, hormonal contraceptive or intrauterine device, if premenopausal).
* Patient with critical ischemia of the lower limb (stage 4-5-6 according to the Rutherford classification) requiring revascularization by sub-gonal bypass
* Patient eligible and scheduled for bypass in venous allograft stored at + 4 ° C with distal anastomosis below the knee
* Patient without usable autologous great Saphenous vein
* Subject affiliated or beneficiary of a social security scheme
* Patient having received the appropriate information concerning the objectives and procedures of the study and having declared his non-objection.

Exclusion Criteria:

* Use of unscheduled allografts
* Patient requiring composite bypass in AGV + autologous venous material or prosthesis
* Patient requiring replacement of infected prostheses
* Patient with acute ischemia
* Patient with severe coagulation disorders
* Patient classified physical status score 4
* Patient participating in another clinical trial
* Potential allergy to the graft
* Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Survival rate of patients at 2 years with lower limb rescue
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Private Hospital of Dijon
Study officials:
References:
Clinical trial NCT06330012: The Resistance Mechanism of Trastuzumab Deruxtexan in HER2 Positive Breast Cancer Patients.
Official title: Spatial Transcriptomic Approach for Revealing the Resistance Mechanism of Trastuzumab Deruxtexan in HER2 Positive Breast Cancer Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HER2-positive Breast Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study is the spatial transcriptomic approach for revealing the resistance mechanism of trastuzumab deruxtexan in HER2 positive breast cancer patients.


Eligibility criteria: Inclusion Criteria:

* HER2 positive breast cancer
* Stage IV disease
* Treated with T-Dxd
* Available FFPE samples

Exclusion Criteria:

* TNBC breast cancer
* Hormone receptor positive breast cancer
* Non-available FFPE samples
* Treated except T-Dxd

Primary outcomes:
measure: Spatial transcriptomic analysis
timeFrame: Before chemotherapy, curative surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ji-Yeon Kim
Study officials:
References:
Clinical trial NCT03627312: Omega-3 Supplements to Reduce Antisocial Behaviour in Young Offenders
Official title: Omega-3 Supplements to Reduce Antisocial Behaviour in Young Offenders: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Antisocial Behavior
Lead sponsor: Singapore Prison Service
Sponsor class: OTHER_GOV
Collaborators: name: University of Pennsylvania
First posted: 2018-08-13
Enrollment: 181
Sex: MALE
Minimum age (years): 16
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to examine the effects of providing omega-3 supplements on young offenders' antisocial behaviour. Participants will be randomized into three groups: (1) Omega-3, (2) Placebo and (3) Treatment as Usual. Self report and correctional officer ratings of behaviour will be assessed at 0 months (baseline), 3 months (end of supplementation), 6 months and 12 months. The investigators hypothesize that omega-3 supplementation will reduce antisocial behaviour among the young offenders.

Detailed description: This study follows up on two prior omega-3 supplementation Randomized Controlled Trial (RCT) conducted on young offenders - one in the UK (Gesch et al. 2002) and the Netherlands (Zaalberg et al. 2009).

Eligibility criteria: Inclusion Criteria:

* Admission into young offender's institution

Exclusion Criteria:

* Allergy to fish and fish products
* Serious mental illness and intellectual disability
* Ability to read and write at the level required to complete self report questionnaires

Primary outcomes:
measure: Change in Antisocial Behaviour (Aggression) at 3 months, 6 months and 12 months
timeFrame: 0 Months (baseline), 3 Months, 6 Months, 12 Months
measure: Change in Antisocial Behaviour (Conduct and Oppositional Defiance) at 3 months, 6 months and 12 months
timeFrame: 0 Months (baseline), 3 Months, 6 Months, 12 Months
Secondary outcomes:
measure: Schizotypal Personality
timeFrame: 0 Months (baseline), 3 Months, 6 Months, 12 Months
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: Adrian Raine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02237612: Diffusion-Weighted MRI in Staging Patients With Localized Prostate Cancer
Official title: Diffusion-Weighted MRI for Staging in Localized Prostate Cancer: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenocarcinoma of the Prostate
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-09-11
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot clinical trial studies how well diffusion-weighted magnetic resonance imaging (MRI) works in staging patients with prostate cancer that has not spread to nearby lymph nodes or other parts of the body. New imaging techniques, such as diffusion-weighted MRI, may be a less invasive way of predicting the stage and grade of prostate cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To determine the sensitivity and specificity of diffusion-weighted MRI for pathologic T3 stage prostate cancer using a 3 Tesla (3T) magnet with a surface coil.

OUTLINE:

Patients undergo diffusion-weighted MRI of the pelvis.

Eligibility criteria: Inclusion Criteria:

* Biopsy-documented adenocarcinoma of the prostate which is intermediate or high risk, defined as possessing one or more of the following features:

  * Gleason \>= 7
  * \> 50% biopsy cores +
  * Prostate-specific antigen (PSA) \>= 10
* Interested in undergoing a radical prostatectomy as definitive management for prostate cancer
* No clinical or radiographic evidence for distant metastatic disease

  * In subjects with PSA \< 20 no radiographic staging is required in the absence of clinical symptoms for distant metastatic disease; for those with PSA \> 20, a bone scan must document lack of concern for bone involvement

Exclusion Criteria:

* Ineligible for surgery due to cardiac, pulmonary, or other major comorbidity factor
* History of claustrophobia
* Pacemaker or other implanted metal objects which would make subject ineligible for MRI, per standard criteria
* Unable to give written informed consent

Primary outcomes:
measure: Number of patients found to have extracapsular extension and seminal vesicle involvement using Diffusion-Weighted MRI
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Tanya Dorff
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05410912: Varicose Vein in Patients Under the Age of 40
Official title: Varicose Vein in Patients Under the Age of 40
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Varicose Veins
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary great saphenous varicose veins (GSVV) and treated by great saphenous vein stripping and ambulatory phlebectomy.

Brief summary: Varicose veins are a result of valvular insufficiency and presented with twisted, enlarged veins. They not only cause cosmetic concerns but also lead to limb edema, skin pigmentation/lipodermatosclerosis, and even venous ulcers. This disease affects a large percentage of the population. Although there have been several researches on the risk factors for varicose veins and the outcomes of alternative therapies , there is currently limited data focusing on varicose veins in young patients. In this case-control study, we wanted to assess the risk factors for varicose veins in patients under the age of 40, as well as their long-term results of surgery.


Eligibility criteria: Inclusion Criteria:

1. great saphenous varicose veins (GSVV) with saphenous vein reflux \>0.5s.
2. lower extremity venography excluding iliac vein compression;
3. treated by great saphenous vein stripping and ambulatory phlebectomy.
4. the patient had a minimum follow-up of five years.

Exclusion Criteria:

1. secondary varicose veins (defined as varicose veins caused by deep vein thrombosis, iliac venous compression or venous injury etc.);
2. small saphenous veins;
3. treated by endovenous ablation/laser or sclerotherapy alone.

Primary outcomes:
measure: Postoperative varicose veins sequelae
timeFrame: Five years after surgery.
measure: Postoperative quality of life
timeFrame: Five years after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: