louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00220220: Amlodipine as add-on to Olmesartan in Hypertension
Official title: Efficacy and Safety of Amlodipine Used as add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 20 mg Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 429
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: Test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with olmesartan alone.


Eligibility criteria: Inclusion Criteria:

* Mean sitting BP of greater than or equal to 140/90-115 mmHg and mean 24h dBP greater than or equal to 80 mmHg with at least 30% of daytime readings greater than 85 mmHg prior to randomization.

Exclusion Criteria:

* Secondary hypertension of any aetiology;
* Any serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s);
* History of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, congestive heart failure, hypertensive encephalopathy, stroke or TIA within the last 6 months.

Primary outcomes:
measure: Mean change in trough sitting diastolic blood pressure (dBP) assessed by conventional BP measurements after 8 weeks of double-blind treatment.
Secondary outcomes:
measure: Mean change in trough sitting sBP and mean BP daytime, nighttime and 24h ABPM after 8 weeks of double-blind treatment.
measure: Responder rate, defined as number (%) of patients achieving BP goals during 8 weeks of double-blind treatment.
measure: Safety and tolerability
Other outcomes:
Locations:
city: Hamburg
country: Germany
city: Magdeburg
country: Germany
city: Messkirch
country: Germany
city: Stuhr
country: Germany
city: Tann
country: Germany
city: Worpswede
country: Germany
Study officials:
name: Peter Brommer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barrios V, Brommer P, Haag U, Calderon A, Escobar C. Olmesartan medoxomil plus amlodipine increases efficacy in patients with moderate-to-severe hypertension after monotherapy: a randomized, double-blind, parallel-group, multicentre study. Clin Drug Investig. 2009;29(7):427-439. doi: 10.2165/00044011-200929070-00001.
Clinical trial NCT02031120: Management of Drug Hypersensitivity in Children
Official title: Improved Management Based on Pathophysiology of Drug Hypersensitivity in Childhood
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Drug Hypersensitivity
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 207
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with suspected drug allergies in a pediatric hospital (including ambulatory departments)

Brief summary: The aim of this study is (1) to assess the incidence of suspected drug allergies in a pediatric hospital and the proportion in which these reactions are confirmed to be allergic; (2) to evaluate the diagnostic values of the different allergy tests available; (3) to investigate the pathophysiology of drug allergies, particularly by investigating the role of viruses, and by performing HLA typing and a gene expression profile both in the acute phase of the reaction and 2 months later.


Eligibility criteria: Inclusion Criteria:

* Participation will be proposed to any children (0 to 16 years) receiving one or several drug(s) and developing one of the following clinical manifestations: urticaria, maculopapular rash, bullous eruption, flush, anaphylaxis, serum sickness-like disease, SJS, TEN, DRESS or fever linked to drug intake.

Exclusion Criteria:

* Patients will be excluded if the symptoms occur more than 72 hours after any treatment was stopped or if the symptoms are clearly linked to another cause (measles, rubeola, roseola, varicella, fifth disease, Gianotti-Crosti syndrome, scarlet fever, Gibert's pityriasis or food allergy).

Primary outcomes:
measure: Incidence of suspected drug allergies in a pediatric hospital and the proportion in which these reactions are confirmed to be allergic
timeFrame: 3 years
Secondary outcomes:
measure: Evaluation of the diagnostic values of the different allergy tests available
timeFrame: 3 years
measure: Determination of the role of viruses, HLA typing and gene expression profile both in the acute phase of the reaction and 2 months later
timeFrame: 3 years
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
affiliation: University Hospital, Geneva
name: Jean-Christoph Caubet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05805020: Cellvizio to Evaluate Margins in Crohn's Ileal Disease
Official title: Is There a Concordance Between the Cellvizio With an Intravenous Injection of Fluorescein and the Pathology to Determine the Microscopic Inflammation at the Ileal Resection Margins in Crohn's Ileal Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn Disease
Resection Margins
Recurrence
Keywords: Crohn Disease
Resection Margins
recurrence
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 41
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: Crohn disease is an inflammatory bowel disease. A surgical procedure is required in about 80% of cases. Surgery doesn't cure from Crohn's disease but the type of surgery remains important as there are several intraoperative risk factors for recurrence. Among these factors the microscopic inflammation at the resection margins. This is a crucial point, if the resection is too large there is a risk of short bowel syndrome, if the resection is too short (microscopic inflammation at resection site), there is a higher risk of postoperative recurrence (75% vs 46% at 18 months). Surgeons have to do a limited resection (2cm from macroscopic crohn disease). However this macroscopic non inflammatory resection margin can be microscopically inflammatory (up to 80%). Thus it is useful to evaluate if there is a microscopic inflammation at the resection margin. Moreover there is an increase interest for the role of the mesentery for recurrence but its role remains unclear. It is of interest to clarify the border between the inflammatory and non-inflammatory mesentery. Cellvizio is a confocal laser endomicroscopy providing the possibility of obtaining in vivo high-magnification images of the gut epithelium. This allows real-time examination of the gastrointestinal mucosa at the cellular and subcellular level. Cellvizio has never been used during surgery for Crohn disease.

The aim of this study is to evaluate the intraoperative use of Cellvizio (using the CelioFlex microsonde) with an intravenous injection of fluorescein to determine the best ileal resection margins in Crohn disease.


Eligibility criteria: Inclusion Criteria:

* Patients who need a ileocaecal resection for a Crohn disease whatever is the phenotype of the Crohn's disease

Exclusion Criteria:

* Patients\<18 years old,
* pregnancy or breastfeeding,
* patients who have an ileocolic resection for a surgical recurrence of the Crohn's disease.
* Patients operated in emergency for a peritonitis,
* patients who have a contra-indication for fluorescein injection or severe allergia to any drug

Primary outcomes:
measure: concordance between the Cellvizio pictures and the pathology incidence
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
Study officials:
References:
Clinical trial NCT03344120: Symptoms Comparison: Suture-stent vs Conventional Double-J Stents After Ureterorenoscopy. A Prospective Randomized Trial
Official title: Comparison Between Symptomps Related to Pigtail Suture Stent Versus Conventional Double J After Ureterorenoscopy for Stone Treatment. A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptoms and Signs
Pain
Ureteral Calculi
Keywords: Symptoms and Signs
Pain
Ureteral Calculi
Ureteroscopy
Ureteral Stents
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Double J ureteral stents (DJ) are widely used in urological practice and commonly inserted after most of ureteroscopies. Stent-related symptoms (SRS) represent a major issue. Many research lines have been explored with the aim of decreasing SRS: Vogt et al. projected a self-made pigtail suture stent (PSS) replacing the distal pigtail with a 0.3 Fr suture reaching the bladder, showing decreased SRS and good tolerance. To date, these promising results hasn't been confirmed by a prospective randomized controlled trial (RCT) involving a marketed PSS. Thus, we designed a prospective single-blind RCT to compare SRS caused by marketed PSS and conventional DJ after uncomplicated URS for stone treatment.


Eligibility criteria: Inclusion Criteria:

* ureteral or renal stones \< 2 cm needing treatment through semirigid or flexible URS and laser lithotripsy
* stone-free procedure and absence of intraprocedural complications
* WHO performance status 0-2

Exclusion Criteria:

* significant residual fragments at the end of the procedure
* intraprocedural complications (e.g. ureteral damage or stricture)
* indwelling double J stent
* acute kidney failure
* urinary tract infection
* urinary tract abnormalities
* pathologies or medications potentially influencing voiding pattern and pain perception

Primary outcomes:
measure: Urinary Symptom Index Score
timeFrame: 14 days
Secondary outcomes:
measure: USSQ domains' scores
timeFrame: 14 days
measure: USSQ domains' scores
timeFrame: 2 days
measure: USSQ single answers
timeFrame: 14 day
measure: USSQ single answers
timeFrame: 2 days
measure: 2 weeks USSQ domains' subscores adjusted for baseline
timeFrame: 6 weeks
measure: complications and adverse events
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Turin
country: Italy
facility: AOU Città della Salute e della Scienza
Study officials:
affiliation: A.O.U. Città della Salute e della Scienza
name: Andrea Bosio
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bosio A, Alessandria E, Agosti S, Vitiello F, Vercelli E, Bisconti A, Piana P, Fop F, Gontero P. Pigtail Suture Stents Significantly Reduce Stent-related Symptoms Compared to Conventional Double J Stents: A Prospective Randomized Trial. Eur Urol Open Sci. 2021 May 10;29:1-9. doi: 10.1016/j.euros.2021.03.011. eCollection 2021 Jul.
Clinical trial NCT02590120: Enteral Nutrition and Amino Acid Absorption
Official title: Comparaison du Profil d'Absorption Des Acides aminés Entre Une Nutrition entérale Semi-élémentaire et Une Nutrition entérale polymérique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malabsorption
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2015-10-28
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate amino acid absorption with two different type of proteins.


Eligibility criteria: Inclusion Criteria:

* Patient with gastrointestinal disorder : citrulline plasma concentration \< 20 µmol/L and/or xylose plasma concentration \< 1,7 mmol/L
* Patient under enteral nutrition at home
* Patient already receiving 1 L by day

Exclusion Criteria:

* Obese patient BMI \> 30
* Diabetes
* Renal or liver failure
* Glucocorticoids treatment

Primary outcomes:
measure: Amino acid absorption profile
timeFrame: 48 hours
Secondary outcomes:
measure: Tolerance
timeFrame: 48 hours
measure: Nutritional status
timeFrame: 48 hours
measure: Essentials amino acid absorption
timeFrame: 48 hours
measure: Insulinemia evolution
timeFrame: 48 hours
measure: Link between amino acid and insuline
timeFrame: 48 hours
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU de Lille
Study officials:
affiliation: Nestle Health Science
name: Julien Gautry, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02271620: The Prevalence and Clinical Characteristics of Children With Local Allergic Rhinitis
Official title: The Prevalence and Clinical Characteristics of Children With Local Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Allergic Rhinitis
Keywords: 1 prevalence
2 children
3 local allergic rhinitis
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 53
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: * To determine prevalence of local allergic rhinitis (LAR)
* To evaluate clinical characteristic and severity of local allergic rhinitis
* To measure changing of tryptase and Specific IgE for Dermatophagoides pteronyssinus (Dp) after nasal allergen provocation test (NAPT)

Detailed description: Children 8-18 years with NAR were recruited. A NAPT with Der p 1 solutions (NAPT-DP) at 200 AU/mL, 600 AU/mL and 2000 AU/mL at 15-minute interval was performed, respectively. The immediate responses to NAPT-DP were assessed using symptoms score, peak nasal inspiratory flow (PNIF) and acoustic rhinometry (ARM). The nasal tryptase and sIgE-DP were measured at baseline, 15 min and 1 h after positive NAPT-DP. Allergic rhinitis (AR) patients were used as positive control.

Eligibility criteria: Inclusion Criteria:

* Children 8-15 years who were diagnosed with nonallergic rhinitis (NAR) at least 1 year
* No respiratory infections in the previous 4 weeks
* No following treatment of
* systemic corticosteroid 4 weeks
* intranasal corticosteroid 2 weeks
* oral antihistamine 1 week
* leukotriene antagonist 1 week

Exclusion Criteria:

* Patients with underlying disease:
* chronic rhinosinusitis and nasal polyp
* immunological disease
* chronic renal disease
* hepatobiliary disease
* cardiovascular disease
* cancer
* Parental withdraw consent
* Patient with uncontrolled asthma, peak expiratory flow rate (PEFR) \< 80% of predicted

Primary outcomes:
measure: prevalence of local allergic rhinitis (LAR)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Division of allergy and immunology, Department of pediatric, Siriraj Hospital
state: Bangkok
city: Bangkok
country: Thailand
facility: Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: 66815818803
name: Orathai Piboonpocanun, assoc. prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05899920: Clinical One-stage Controlled Study of reSistant Arterial Hypertension for the desiGning of a personAlized Approach to Therapy
Official title: Clinical One-stage Controlled Study of reSistant Arterial Hypertension for the desiGning of a personAlized Approach to Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Resistant Arterial Hypertension
Keywords: antihypertensive drugs
concentration
HPLC MS/MS
Lead sponsor: Ryazan State Medical University
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study was planned to assess the concentration of antihypertensive drugs in the blood plasma in patients with controlled and uncontrolled arterial hypertension. Methods: it is planned to include patients with arterial hypertension taking 3 antihypertensive drugs (indapanide, lisinopril or valsartan, amlodipine). Based on the results of 24-hour blood pressure monitoring, the patients will be randomized into two groups: The first group - the patients with controlled AH; The second group - the patients with uncontrolled AH. Venous blood was taken in both groups of the patients in the morning before and 2 hours after taking drugs to assess the concentration of lisinopril, amlodipine, valsartan and indapamide. Concentation of assesed antihypertensive drugs will be compared in both groups.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent form;
* An established diagnosis of AH based on the Clinical Guidelines "Arterial hyperten-sion in adults", approved by the Scientific and Practical Council of the Ministry of Health of the Russian Federation, 2020;
* Mandatory patient compliance with recommendations for lifestyle modification in accordance with the Clinical Guidelines "Arterial hypertension in adults", approved by the Scientific and Practical Council of the Ministry of Health of the Russian Federation, 2020 .
* Regular administration of any two antihypertensive drugs (lisinopril, amlodipine, valsartan) in combination with indapamide for a month, possibly in fixed combinations, in stable dosages;
* Fertile female patients must use proper methods of contraception throughout the study period.

Exclusion Criteria:

* Patient's connection with the organization or conducting of the study;
* Pregnancy.

Primary outcomes:
measure: Plasma Concentration of lisinopril, valsartan, amlodipin, indapamide, metoprolol
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Ryazan
country: Russian Federation
facility: Ryzan State Medical University
Study officials:
References:
Clinical trial NCT01372020: Neuromuscular Electrical Therapy in Venous Ulcers
Official title: The Effect of Neuromuscular Electrical Therapy on Pain in Patients With Venous Ulcers: a Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Venous Insufficiency
Keywords: Varicose ulcer
wound healing
electrical stimulation
Lead sponsor: Faculdade Evangelica do Parana
Sponsor class: OTHER
First posted: 2011-06-13
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of neuromuscular electrical stimulation in the treatment of venous ulcers with difficulty of repair could be an alternative therapeutic favoring devitalized tissues and hence the pain.

The aim of this study is to evaluate the effect of neuromuscular electrical stimulation on pain and area of venous ulcers in patients with venous insufficiency.

Detailed description: The aim was to evaluate the effect of neuromuscular electrical stimulation on pain and area of venous ulcers in patients with venous insufficiency. In a simple-blind controlled clinical study, 20 subjects with venous ulcers with age over 50 years will be divided in two groups:neuromuscular electrical stimulation(n=10) and control group (n=10). Pain (by Visual Analogue Scale) and the ulcer area (by planimetry on graph paper and the software ImageJ ®) were measured.

Eligibility criteria: Inclusion Criteria:

* Subjects of both genders
* aged over 50 years
* sedentary and with clinical diagnosis of chronic venous insufficiency with ulcer in lower limbs will be included

Exclusion Criteria:

* Subjects with pacemakers
* diabetes
* uncontrolled hypertension
* osteomyelitis and pain of unknown origin
* unable to walk or make use of drugs that acted directly on the healing process will be excluded

Primary outcomes:
measure: Pain
timeFrame: the subjects will be followed for a period of 4 weeks.
Secondary outcomes:
measure: ulcer area
timeFrame: the patients will be folloed for the 4-weeks.
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Faculdade Dom Bosco
state: Parana
Study officials:
affiliation: Facukdade Dom Bosco
name: Korelo Raciele, M.sC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carley PJ, Wainapel SF. Electrotherapy for acceleration of wound healing: low intensity direct current. Arch Phys Med Rehabil. 1985 Jul;66(7):443-6.
citation: Korelo RI, Valderramas S, Ternoski B, Medeiros DS, Andres LF, Adolph SM. Microcurrent application as analgesic treatment in venous ulcers: a pilot study. Rev Lat Am Enfermagem. 2012 Jul-Aug;20(4):753-60. doi: 10.1590/s0104-11692012000400016. English, Portuguese, Spanish.
Clinical trial NCT06430320: Ascertaining Longterm Outcomes of Fibroid Treatments
Official title: Long Term Effectiveness of Uterine Sparing Fibroid Treatments
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Uterine Fibroid
Keywords: Uterine fibroid treatment
Multi-center, prospective, observational cohort study
Uterine-sparing treatment procedures
Patient-reported outcomes
Quality of life
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: University of California, San Francisco
name: University of North Carolina, Chapel Hill
First posted: 2024-05-28
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who were previously enrolled in either the COMPARE-UF or ULTRA study

Brief summary: The goal of the ALOFT study is to understand the health of women in the 12 years following a uterine fibroid (UF) treatment. ALOFT is a multi-center, prospective, observational cohort study of approximately 700 women who have undergone uterine-sparing treatment procedures for UF and previously participated in the longitudinal studies COMPARE-UF (NCT02260752) or ULTRA (NCT02100904).

The primary uterine sparing treatment procedures undergone by study participants are myomectomy, endometrial ablation (EA), uterine artery embolization (UAE) and laparoscopic radiofrequency ablation (RFA). A smaller number of women may be studied who underwent focused ultrasound, intrauterine device (IUD), and medical management.

Two follow-up study contacts with COMPARE-UF and ULTRA participants will occur to assess changes in UF symptoms and treatment failure which is defined as the need for another UF treatment procedure. Questionnaires will be used to collect data on patient-reported characteristics and outcomes and quality of life.

The study's analyses will focus on comparisons of primary and secondary outcomes among women.


Eligibility criteria: Inclusion Criteria:

* Participant has to have been enrolled in either the COMPARE-UF or ULTRA study
* Participant had a uterine-sparing fibroid treatment at enrollment in COMPARE-UF or ULTRA study

Exclusion Criteria:

* Individuals who were not consented into the original COMPARE-UF or ULTRA study
* Individuals who did not have a uterine-sparing fibroid treatment at enrollment in COMPARE-UF or ULTRA study

Primary outcomes:
measure: Time to treatment failure
timeFrame: Up to 12 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: Henry Ford Health
name: Ganesa Wegienka, PhD
role: PRINCIPAL_INVESTIGATOR
References: