louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02779530: CYP4A11 and CYP4F2 Gene Variants as Makers of Cardiovascular Adverse Events of Non-steroidal Anti-inflammatory Drugs
Official title: Evaluation of CYP4A11 and CYP4F2 Gene Variants as Makers in Edema and Elevated Blood Pressure Occurrence After Nonsteroidal Anti-inflammatory (NSAID) Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Drug-Related Side Effects and Adverse Reactions
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: Randomized, double-blinded, cross-over and placebo controlled clinical trial to evaluate the association between genetic polymorphism of CYP4F2 with cardiovascular adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs). Two groups were included according the CYP4F2 V433M genetic polymorphism (control - MM, N=7 vs. VV or VM variants, N=13). According the sample size planned, a mean difference of total body water delta between groups (control vs. polymorphic) of at least allow 10% could be observed.


Eligibility criteria: Inclusion Criteria: Healthy volunteers 18-65 years-old -

Exclusion Criteria: Use of drugs and without clinical history of adverse effects of NSAIDS

-

Primary outcomes:
measure: Edema
timeFrame: after 6 days of diclofenac and placebo
Secondary outcomes:
measure: Blood Pressure
timeFrame: after 6 days of diclofenac and placebo
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: Unidade de Pesquisa Clínica HCRP-USP
state: Sao Paulo
Study officials:
References:
Clinical trial NCT00937430: Bowel Preparation and Pelvic Organ Prolapse Surgery
Official title: Bowel Preparation and Return of Bowel Function After Pelvic Organ Prolapse Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Pelvic organ prolapse
Bowel preparation
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2009-07-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to find out if performing a bowel preparation prior to pelvic organ prolapse surgery has any effect on the return of bowel function after surgery.


Eligibility criteria: Inclusion Criteria:

* Are between the ages of 21-90 years.
* Have a posterior vaginal wall prolapse.
* Are undergoing vaginal prolapse reconstructive surgery including posterior repair with suspension of the vaginal apex (top) to the ligaments in your pelvis, repair of the cul de sac or "enterocele", with or without anti-incontinence surgery.
* Are receiving general anesthesia.

Exclusion Criteria:

* Patient undergoing concomitant anal sphincteroplasty, rectovaginal fistula repair, rectopexy, or rectal resection/reanastomosis.
* Patient undergoing any mesh augmentation.
* Patient with any neurological condition involving bowel function.
* Patient on regular narcotic medication preoperatively.
* Patient does not want to be in the group she was randomized to.
* Patient currently pregnant or planning to become pregnant, or breastfeeding.
* Patient with ascites.
* Patient with known or suspected gastrointestinal obstruction or perforation.
* Patient with history of hyperparathyroidism.
* Patient with dehydration.
* Patient with active inflammatory bowel disease.
* Patients with congestive heart failure.
* Patients with dialysis dependent renal disease.

Primary outcomes:
measure: Measure the return of bowel function after pelvic organ prolapse surgery.
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Rachel N Pauls, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03374930: Influence of Oesophageal Contractile Reserve in High Resolution Manometry on Post Operative Dysphagia After Anti-reflux Surgery
Official title: Influence of Oesophageal Contractile Reserve in High Resolution Manometry on Post Operative Dysphagia After Anti-reflux Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2017-12-15
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main objective of this study is to evaluate, in a prospective cohort, the link between preoperative contractile reserve of oesophagus evaluated by high resolution manometry (HRM) and the occurrence of post operative dysphagia after anti-reflux surgery.


Eligibility criteria: Inclusion Criteria:

* Patient with an indication validated at a fundoplication directed by a visceral surgeon from Vienne county
* Patient sent for the realization of a preoperative HRM,
* Patient giving consent to participate in the study.

Exclusion Criteria:

* Patient unable to sign a consent or protected (minors, pregnant women, patient under guardianship),
* History of oesophageal surgery or radiotherapy,
* History of systemic pathology with oesophageal involvement,
* Contraindication to an oesophageal manometry : altered general status and vigilance , important swallowing disorders

Primary outcomes:
measure: presence of dysphagia
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Hospital Center
Study officials:
References:
Clinical trial NCT05513430: Pharmacological and Nonpharmacological Factors That Contribute Blood Pressure Control
Official title: Pharmacological and Nonpharmacological Factors That Contribute Blood Pressure Control
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension,Essential
Lead sponsor: Maltepe University
Sponsor class: OTHER
Collaborators: name: Istanbul University
First posted: 2022-08-24
Enrollment: 176
Sex: ALL
Maximum age (years): 74
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: hypertensive patients

Brief summary: Study is an observational study among hypertensive patients

Detailed description: Objective: To investigate drug adherence and lifestyle behaviors affecting the blood pressure (BP) control among hypertensive patients that have uncontrolled and controlled BP.

Eligibility criteria: Patient inclusion criteria were as follows:

* aged between 38 and 74 years,
* hypertension diagnosis history of at least 6 months
* use of at least one antihypertensive medication.

Exclusion Criteria:

-not willing to join the clinical trial

Primary outcomes:
measure: health related quality of life.
timeFrame: at the time of the beginning of the study
measure: Age
timeFrame: at the time of the beginning of the study
measure: Gender
timeFrame: at the time of the beginning of the study
measure: BMI
timeFrame: at the time of the beginning of the study
Secondary outcomes:
measure: complementary and alternative medicine use
timeFrame: at the time of the beginning of the study
Other outcomes:
Locations:
Study officials:
References:
citation: Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force Members. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2013 Jul;31(7):1281-357. doi: 10.1097/01.hjh.0000431740.32696.cc. No abstract available.
citation: Özünal, Z. G., Tahirbegolli, I. A., Baykal, M., Belen, A. T. E. Ş., Tahirbegolli, B., KILIÇ, Y., ... & Üresin, A. Y. (2019). The drug adherence and lifestyle factors that contribute to blood pressure control among hypertensive patients.
Clinical trial NCT01111630: Study of Erythropoietin (EPO) Administration Schedule
Official title: Compare the Hemoglobin and Hematocrit Variability Between Once & Three Times Weekly Erythropoietin Therapy for the Anemia in Patients With Maintenance Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Renal Failure
Anaemia
Keywords: chronic renal failure
Anaemia
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-04-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the hemoglobin and hematocrit variability between once and three times weekly erythropoietin therapy for the anemia in patients with maintenance dialysis.


Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 80.
* Dialysis for at least 3 months.
* Epoetin treatment for the last 3 months.
* Baseline hemoglobin (Hb) value of \>= 9.0 g/dL and \< 13.0 g/dL.
* Baseline mean weekly epoetin maintenance dose ≤ 12,000 IU
* Patients who agree to participate in this study in writing.

Exclusion Criteria:

* Hemoglobinopathies, i.e. sickle cell disease, thalassemia of all types.
* Hemolysis as defined
* Gastrointestinal bleeding necessitating treatment (medication, transfusion) within the last 3 months.
* Patients with uncontrolled hypertension.
* Acute infection of unstable systemic inflammatory disease.
* Current malignant disease.
* High likelihood of early withdrawal or interruption of the study (e.g. severe diseases within the last 3 months, such as myocardial infarction, unstable angina, stroke, deep venous thrombosis).
* Life expectancy below 12 months.
* Planned elective surgery during the study period.
* Blood transfusions within the last 3 months.
* Pregnancy and lactation.
* Other conditions regarded as unsuitability by investigator.

Primary outcomes:
measure: The hemoglobin variability between once & three times weekly administration
timeFrame: 24 weeks
Secondary outcomes:
measure: The hematocrit variability between once & three times weekly administration
timeFrame: 24 weeks
measure: Mean value of Hb and Hct between once & three times weekly administration
timeFrame: 24 weeks
measure: Drop out rate during dose fix period
timeFrame: 24 weeks
measure: Mean value of Hb and Hct during dose fix period
timeFrame: 24 weeks
measure: Variability of Hb and Hct during dose fix period
timeFrame: 24weeks
measure: Weekly oetin-beta maintenance dose between once & three times weekly administration
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: NHIC Ilsan Hospital
Study officials:
affiliation: National Health Insurance Service Ilsan Hospital
name: SugKyun Shin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06518330: Psychosis Associated With Methylphenidate in Children and Adolescents
Official title: Psychosis and Hallucinations in Methylphenidate-Treated Children: A Pharmacovigilance Study Using Vigibase
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychosis
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 46233
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a possible drug-induced adverse effect

Brief summary: perform a study in VigiBase® to assess if methylphenidate was associated with an over-reporting of psychosis including hallucinations in children and adolescents and to characterize those psychosis.


Eligibility criteria: Inclusion Criteria:

Case reported in the World Health Organization (WHO) database of individual safety case reports until 16/02/2024 in children and adolescents treated with drugs with an indication in ADHD.

Adverse events reported were including a list of MedDRA Preferred Terms related to psychosis

Exclusion Criteria:

Chronology not compatible between the drug and the toxicity

Primary outcomes:
measure: Correlation between methylphenidate and psychosis in children and adolescents using a disproportionality analysis in Individual Case Reports involving at least one liable drug with an indication in ADHD.
timeFrame: from the 01/01/1967 to the 16/02/2024
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital, Department of Pharmacology
Study officials:
References:
Clinical trial NCT05583630: Ligament Tension Measurement in Knee Arthroplasty
Official title: Ligament Tension Measurement in Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Arthropathy
Keywords: ligament tension, knee arthroplasty
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population are those receiving primary knee arthroplasty

Brief summary: 1. To develop a new type of knee joint pressure detection device and demonstrate its feasibility
2. To analyze individual differences of knee ligament tension using the new device and explore the influencing factors of ligament tension
3. To explore the correlation between knee ligament tension and postoperative knee function


Eligibility criteria: Inclusion Criteria:

* Patients receiving primary knee arthroplasty

Exclusion Criteria:

* Patients having had a surgery history of the ipsilateral knee

Primary outcomes:
measure: Ligament tension
timeFrame: During operation
measure: Pre-operative knee function
timeFrame: 1day before operation
measure: Post-operative knee function
timeFrame: The 3rd day after operation
measure: Post-operative knee function
timeFrame: The 6th week after operation
measure: Post-operative knee function
timeFrame: The 3rd month after operation
measure: Post-operative knee function
timeFrame: The 12th month after operation
Secondary outcomes:
measure: Pre-operative infection test
timeFrame: 1day before operation
measure: Pre-operative infection test
timeFrame: 1day before operation
measure: Pre-operative infection test
timeFrame: 1day before operation
measure: Post-operative infection test
timeFrame: The 1st day after operation
measure: Post-operative infection test
timeFrame: The 1st day after operation
measure: Post-operative infection test
timeFrame: The 1st day after operation
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Zhihong Xu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02823730: Registry Experience at the Washington Hospital Center With Drug Eluting Stents - Synergy
Official title: Registry Experience at the Washington Hospital Center With Drug Eluting Stents - Synergy (REWARDS-Synergy)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incidence of Major Adverse Cardiac Events
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a single-center, observational, retrospective registry of 500 patients who have received the Synergy stent. Data will be mined from the DES registry database for the identified Synergy patients at the following time points, in-hospital and then at 1 year, 2 years, 3 years, and 4 years after percutaneous coronary intervention (PCI).

The 500 patients that underwent PCI with a Synergy stent will then be compared to a propensity matched Xience V cohort eligible for similar time points of follow up following the PCI.

Brief summary: To compare the incidence of major adverse cardiac events among a series of patients receiving the Synergy drug-eluting stent with bioabsorbable polymer to historical controls who have received the Promus Premier drug-eluting stent with durable polymer.

Detailed description: The primary objective of this observational, real-world single-center registry is to compare the incidence of major adverse cardiac events among a series of patients receiving the Synergy drug-eluting stent with bioabsorbable polymer to historical controls who have received the Promus Premier drug-eluting stent with durable polymer. The investigators hypothesize that the long-term incidence (each year following implantation, up to 4 years) of major adverse cardiovascular events, after propensity matching for stent type, will be similar between Synergy and Xience V.

Eligibility criteria: Inclusion Criteria:

1. Subject \>18 years of age
2. Underwent PCI with Synergy (alone) DES

Exclusion Criteria:

1. Underwent PCI with a non-Synergy DES (or scaffold) during the same index procedure
2. Patients not taking, or unable to take, dual antiplatelet therapy (DAPT) at the time of screening for the study (patients that discontinue DAPT after enrollment will be included)

Primary outcomes:
measure: Major adverse cardiac events (MACE)
timeFrame: 4 years
Secondary outcomes:
measure: Target lesion revascularization
timeFrame: 4 years
measure: Periprocedural creatine kinase-MB
timeFrame: 4 years
measure: Cardiac death
timeFrame: 4 years
measure: Stent thrombosis
timeFrame: 4 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
Study officials:
References:
Clinical trial NCT01722630: Renal Function During Laparoscopic Surgery
Official title: Dopamine Infusion and Crystalloids Administration Improve Renal Function During Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intra Operative Fluid Management
Keywords: dopamine
laparoscopy
fluid management
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2012-11-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of this study was to investigate the cardiac and renal responses to the administration of different amount of crystalloids, with and without dopamine, during gynaecological laparoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* ASA I
* age 24-42
* patients undergoing gynaecological laparoscopy

Exclusion Criteria:

* cardiovascular diseases
* renal and endocrine disorders
* obesity (BMI \> 30 Kg/m2)
* the assumption of drugs that could interfere with renal parameters considered in the study

Primary outcomes:
measure: estimated glomerular filtration rate, tissue Doppler imaging, E/Ea
timeFrame: patients will be followed for the duration of surgery, an expected average of 3 hours
Secondary outcomes:
measure: total intra operative diuresis (TID)
timeFrame: patients will be followed for the duration of surgery, an expected average of 3 hours
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of the sacred Heart
Study officials:
References:
Clinical trial NCT00533130: Evaluation of the AO Pediatric Classification for Long Bones Fractures Like a Guide for Treatment and Prognosis
Official title: Phase 2/3 Eficacy Study of the AO Pediatric Classification in Treatment and Prognosis of Long Bones Fractures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fractures
Children
Keywords: AO
Pediatric
Classification
Long Bones
fractures
bones
Lead sponsor: Hospital Cruz Roja Mexicana
Sponsor class: OTHER
First posted: 2007-09-21
Enrollment: 100
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: 1. Is the AO Pediatric classification for long bones fractures reproductible?
2. Is the AO Pediatric Classification for long bones fractures a treatment guide?
3. The AO pediatric Classification for long bones fractures could be a prognosis factor?

Detailed description: PROPOUSE:

1. To determinate the efectivity of the AO pediatric classification for long bones fractures.
2. To evaluate the functionality of the AO pediatric classification for long bones fractures.
3. To analyze if the AO pediatric classification for long bones fractures is a prognosis factor

Eligibility criteria: Inclusion Criteria:

Patients:

* Less than 16 years old.
* Open physis.
* Long bone fractures.
* X ray AP \& lateral comparatives.
* Informed consent for parents or tutor.
* Don´t let the treatment during the time of study.

Exclusion Criteria:

* Pathologic fractures.
* Fractures not included en the AO pediatric classification for long bones.
* Diseases that modifying the bone healing: Diabetes mellitus, osteogenesis imperfect, etc.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital Cruz Roja Mexicana, Delegacion Distrito Federal
state: Federal District
Study officials:
affiliation: orthopaedic resident
name: Jorge D Tejada-Hoyos, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06604130: Plasma Exosome RNA to Diagnose Prostate Cancer
Official title: Plasma Exosome RNA Combination for Diagnosing Prostate Cancer: a Prospective, Multicenter Diagnostic Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
RNA
Diagnosis
Combination
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 1200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the present study is to investigate a RNA combination to diagnose prostate cancer.


Eligibility criteria: Inclusion Criteria:

1. Blood prostate-specific antigen PSA\&gt;4ng/dl;
2. Patients suspected of having prostate cancer through clinical symptoms, digital rectal examination, ultrasound examination, magnetic resonance imaging, and PSMA PET/CT examination.
3. The patient is willing to undergo prostate biopsy.

Exclusion Criteria:

1. Previous diagnosis of prostate cancer through prostate biopsy;
2. History of other malignant tumors in the past two years;
3. According to the research physician\&#39;s judgment, serious complications may occur and affect the normal conduct of the experiment

Primary outcomes:
measure: The diagnostic efficacy of plasma exo-RNA panel alone in diagnosing PCa
timeFrame: The time of prostate biopsy and after 6 months follow-up
Secondary outcomes:
measure: Diagnostic efficacy of plasma exo-RNA panel in diagnosing csPCa, insignPCa and its comparison with other imaging methods or blood tests
timeFrame: The time of prostate biopsy and after 6 months follow-up
Other outcomes:
Locations:
city: Xian
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
References: