louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02623816: Symptom Control Satisfaction With Proton Pump Inhibitor Regimen
Official title: Prospective Study Assessing Patient Satisfaction of Symptom Control With Proton Pump Inhibitor Dosing Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heartburn
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2015-12-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall aim of this study is to assess if patients with persistent gastroesophageal reflux disease (GERD) symptoms receiving sub-optimal omeprazole dosing experience improvement in GERD symptoms when prescribed an optimal dosing regimen. The optimal dosing regimen is defined as taking omeprazole 30 minutes prior to the first meal of the day.

Detailed description: GERD remains a common gastrointestinal complaint, resulting in 6% of outpatient visits. The economic burden is significant with direct costs exceeding $12 billion/year and indirect cost as high as $75 billion/year. The primary aim of this study was determine whether a brief educational intervention optimizing proton pump inhibitor (PPI) dosing would reduce GERD symptoms using the gastroesophageal reflux disease symptom assessment scale (GSAS) questionnaire. Further, secondary analysis would utilize the results of the trial and combine them with costs related to uncontrolled GERD to estimated the potential economic impact.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* taking omeprazole 20 mg
* episodic heartburn at least 3 times per week
* provides consent and be willing to complete study questionnaires
* read, speak and write English

Exclusion Criteria:

* weight loss (alarm symptom)
* normal esophagogastroduodenoscopy (EGD) in last one year
* pregnant or women planning on becoming pregnant at any time during the study
* history of Barrett's esophagus
* prior esophageal strictures
* intolerance/allergy to study medications
* patients on plavix or a history of upper gastrointestinal surgery
* investigators or their immediate family (spouse, children, sibling)

Primary outcomes:
measure: Symptom Frequency and Severity/Distress Scores From Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) (Overall)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical System
state: Ohio
Study officials:
affiliation: MetroHealth Medical System
name: M. Michael Wolfe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Waghray A, Waghray N, Perzynski AT, Votruba M, Wolfe MM. Optimal Omeprazole Dosing and Symptom Control: A Randomized Controlled Trial (OSCAR Trial). Dig Dis Sci. 2019 Jan;64(1):158-166. doi: 10.1007/s10620-018-5235-9. Epub 2018 Aug 9.
Clinical trial NCT01468116: The Effect of Roux-en-Y Gastric Bypass on Mitochondrial Function in Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes
Obesity
Keywords: Type 2 diabetes
Gastric bypass surgery
Obesity
Mitochondrial function
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2011-11-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are recruited from the outpatient clinic of endocrinology and the gastrosurgical clinic at Hvidovre University Hospital

Brief summary: Roux-en-Y gastric bypass (RYGB) surgery induces resolution of type 2 diabetes, often within days after surgery and before significant weight loss. The aim of this study is to investigate whether changes in mitochondrial function contributes to the early improvement of type 2 diabetes after RYGB.

Detailed description: Mitochondrial dysfunction has been linked to development of insulin resistance in the muscle and hence to the pathogenesis of type 2 diabetes. Mitochondrial function can be studied non-invasively by 31 Phosphor Magnetic Resonance spectroscopy (31PMRS). In this study we will investigate changes in mitochondrial function using the combination of 31 PMRS and Near Infra-Red Spectroscopy (NIRS) after gastric bypass.

Eligibility criteria: Inclusion Criteria:

* Patients eligible for gastric bypass surgery or cholecystectomy
* Verified type 2 diabetes or normal glucose tolerance by OGTT

Exclusion Criteria:

* Patients unable to fit the dimensions of the MRI-scanner

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre University Hospital
state: Hvidovre
Study officials:
References:
Clinical trial NCT00164216: Efficacy and Effectiveness of Combined Therapy for Uncomplicated Malaria Treatment in Peru
Official title: Evaluation of the Efficacy and Effectiveness of Combined Therapy With Mefloquine and Artesunate for Uncomplicated Malaria Treatment in the Loreto Region (Amazon Basin), Peru
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malaria Falciparum
Keywords: malaria
combination therapy
mefloquine
artesunate
Peru
malaria, uncomplicated
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: National Institute of Health, Peru
First posted: 2005-09-14
Enrollment: 208
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: This is a study of the efficacy and effectiveness of combination therapy for malaria due to P. falciparum in the Loreto Department, Iquitos, Peru. The investigators will enroll subjects ≥ 1 year-old who have a diagnosis of uncomplicated malaria due to P. falciparum. Patients will receive a treatment regimen consisting of mefloquine (25 mg/kg per day for two days) and artesunate (12 mg/kg per day for three days). Patients will be divided into two groups: one will receive drugs under direct supervision and the other will be instructed on how to take the drugs by themselves. Clinical and parasitologic response will be monitored for a follow-up period of 28 days. The findings of this study will be used to guide the Ministry of Health in evaluating its national policy for P. falciparum malaria treatment.


Eligibility criteria: Inclusion Criteria:

* Age \> 1 year
* Axillary temperature ≥ 37.5ºC and/or history of fever in the previous 48 hours without any other evident cause
* Unmixed infection with P. falciparum of between 250 and 100,000 asexual parasites/mm3 as determined by microscopic exam of the thick or thin smear
* An informed consent obtained from the patient or his/her guardian (in case of patients ≤ 18 years old) and assent for children (8-18 years old)
* Willingness to come to the health facility for the following 28 days

Exclusion Criteria:

* Signs or symptoms of severe malaria
* Other severe chronic diseases (e.g., cardiologic, renal, or hepatic diseases; HIV/AIDS; severe malnutrition)
* History of allergy to any of the proposed treatment or its alternatives, i.e. mefloquine, artesunate, quinine, tetracycline, or clindamycin
* Pregnancy (based on urine test), since this group of patients receives other drugs for malaria treatment in accordance with Peruvian national guidelines.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Iquitos
country: Peru
facility: Loreto Healthcare Facility
state: Loreto
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Alexandre Macedo de Oliveira, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Health, Peru
name: Wilmer Marquiño Quezada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04868916: An Observational Study of Japanese Participants With X-linked Retinitis Pigmentosa
Official title: Prospective Observational Study to Estimate the Genotype and Phenotype of Japanese Patients With X-linked Retinitis Pigmentosa Associated With Pathogenic Variants in Retinitis Pigmentosa GTPase Regulator (RPGR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: X-Linked Retinitis Pigmentosa
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2021-05-03
Enrollment: 15
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population consists of Japanese participants with X-linked retinitis pigmentosa (XLRP) associated with pathogenic variants in retinitis pigmentosa GTPase regulator (RPGR).

Brief summary: The purpose of the study is to identify a cohort of Japanese participants with X-linked retinitis pigmentosa (XLRP) associated with pathogenic variants in the retinitis pigmentosa GTPase regulator (RPGR) gene and to investigate their associated phenotype.


Eligibility criteria: Inclusion Criteria:

* Have RPGR-associated retinal dystrophy
* Are able to give informed consent or assent, with the guidance of their parent/guardian where appropriate
* Are able to undertake age-appropriate clinical assessments as specified in the protocol

Exclusion Criteria:

* Are unable or unwilling to undertake consent or clinical testing
* Participated in another research study and had intraocular surgery within 3 months of screening
* Significant ophthalmologic diseases

Primary outcomes:
measure: Visual Function
timeFrame: Up to Day 30
measure: Retinal Structure
timeFrame: Up to Day 30
measure: Retinal Function
timeFrame: Up to Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: National Hospital Organization Tokyo Medical Center
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT04545216: Impact of Long Distance Mountain Race on Knee Cartilage.
Official title: Assessment of the Impact of an Ultratrail on the Knee Cartilage by Using T2 MRI: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sports Medicine
Keywords: long-distance running
knee cartilage
magnetic resonance imaging
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy male runners

Brief summary: Long-distance mountain running is increasingly popular among European and North America countries. Long-distance races are organized in various mountains and can reach up to 160 km (100 miles) with several thousands meters of climbing. The pathophysiological consequences of such extreme effort is still a matter a debate. From a muskelo-skeletal perspectives, the potential lower-limb join damage is a major health issue. The present study aims to use objective magnetic resonance imaging (MRI) techniques to describe the consequences of performing long-distance mountain running races on the knee cartilage.

Detailed description: Healthy male runners will perform T2 MRI knee cartilage examination before, immediatly after and 1 month after 3 distinct long-distance mountain races of 40, 55 and 160 km. The physiological responses during the races (speed, heart rate, glycemia) will also be recordered.

Eligibility criteria: Inclusion Criteria:

* no cardiac, respiratory or neuromuscular diseases
* more than 2 years of experience in mountain race
* no contre-indication for participating in a mountain race

Exclusion Criteria:

* history of knee surgery
* contre-indication to MRI

Primary outcomes:
measure: T2 MRI
timeFrame: from before to immediatly after the long-distance race
Secondary outcomes:
measure: Heart rate
timeFrame: Continuous measurement during the race
measure: Glycemia
timeFrame: Continuous measurement during the race
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Doutreleau
Study officials:
affiliation: University Hospital, Grenoble
name: stephane Doutreleau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01989416: Effectiveness of Chlorhexidine Wipe for Prevention of Multidrug-resistant Organisms in Intensive Care Unit Patients
Official title: Effectiveness of Chlorhexidine Wipe for Prevention of Multidrug-resistant Organisms in Intensive Care Unit Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Antibiotic Resistant Infection
Keywords: colonization
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 481
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine 2% chlorhexidine wipes are effective in preventing of colonization of multi-drug resistant bacteria in intensive care unit patients.

Detailed description: The purpose of this study is to evaluate the usefulness of bathing with chlorhexidine wipe to reduce the risks of multidrug resistant bacteria acquisition and hospital-acquired bloodstream infection among ICU patients

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Admission in critical care unit eg. ICU, respiratory care unit, Cardiac care unit with in 24 hours
* Expected duration of critical care unit admission \> 48 hours

Exclusion Criteria:

* History of chlorhexidine allergy

Primary outcomes:
measure: The overall rate of Multidrug resistant bacteria acquisition at 7 days after received 2% chlorhexidine wipe bathing versus with soap bathing
timeFrame: 7 days after recieved 2% chlorhexidine wipes
Secondary outcomes:
measure: The overall rate of hospital-acquired bloodstream infections per 1000 patient-days with chlorhexidine wipe bathing versus with soap bathing
timeFrame: 48 hours after recieved 2% chlorhexidine wipes
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Adhiratha Boonyasiri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boonyasiri A, Thaisiam P, Permpikul C, Judaeng T, Suiwongsa B, Apiradeewajeset N, Fakthongphan T, Suddee S, Laoagtipparos W, Thamlikitkul V. Effectiveness of Chlorhexidine Wipes for the Prevention of Multidrug-Resistant Bacterial Colonization and Hospital-Acquired Infections in Intensive Care Unit Patients: A Randomized Trial in Thailand. Infect Control Hosp Epidemiol. 2016 Mar;37(3):245-53. doi: 10.1017/ice.2015.285.
Clinical trial NCT00723216: Japanese Efficacy and Safety Study of Enoxaparin in Patients With Curative Abdominal Cancer Surgery
Official title: Multicenter, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Enoxaparin Sodium (RP54563) 20mg Bid for 14 Days for Prevention of Venous Thromboembolism in Patients With Curative Abdominal Cancer Surgery. Physical Prophylaxis Only Arm [Intermittent Pneumatic Compression (IPC)] Will be Used as an Indicator of Event Rates.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Abdominal Neoplasms
Keywords: Prevention
venous thromboembolism
curative surgery
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-07-28
Enrollment: 151
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of this study is to evaluate the effects of enoxaparin on venous thromboembolism incidence and bleeding rate (major and minor bleeding) in patients undergoing curative abdominal cancer surgery. The secondary objective is evaluate the incidence of adverse events of enoxaparin in these patients.


Eligibility criteria: Inclusion Criteria:

* Malignant tumor patients undergoing laparotomy for which surgery is expected to take 45 minutes or more.

Exclusion Criteria:

* surgery under laparoscope and other endoscopic operations
* clinical signs of deep vein thrombosis
* use of non-steroidal anti-inflammatory drugs from surgery completion until initial administration
* severe hepatic disease or renal disease
* women of childbearing potential, pregnant or lactating.

Primary outcomes:
measure: Venous thromboembolism incidence
timeFrame: 28 days
Secondary outcomes:
measure: Incidence of deep vein thrombosis, pulmonary thromboembolism, and venous thromboembolism incidence except patients with thrombus only in muscle veins, and incidence of proximal vein thrombosis
timeFrame: 28 days
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: International Clinical Development, Clinical Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02149316: Remote Ischemic Preconditioning With Postconditioning in Heart Transplantation Surgery
Official title: Cardioprotective Effects of Remote Ischemic Preconditioning With Postconditioning of the Recipient on Donor Heart in Heart Transplantation Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Ischemic Reperfusion Injury
End Stage Heart Disease
Heart Failure
Cardiomyopathy
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether remote ischemic preconditioning with postconditioning (RIPC+RIPostC) reduces myocardial injury and improves clinical outcomes in heart transplantation surgery.


Eligibility criteria: Inclusion Criteria:

* scheduled for elective orthotopic heart transplantation surgery

Exclusion Criteria:

* peripheral vascular disease affecting the upper arms
* mechanical circulatory support before surgery
* taking the antidiabetic sulphonylurea, glibenclamide
* cold ischemic time of donor heart \> 12 hours
* repeated heart surgery

Primary outcomes:
measure: serum cardiac troponin I (cTnI)
timeFrame: within 72 hours after aortic declamping
Secondary outcomes:
measure: plasma microRNA-133b (miR-133b)
timeFrame: within 72 hours after aortic declamping
measure: plasma microRNA-208a (miR-208a)
timeFrame: within 72 hours after aortic declamping
Other outcomes:
Locations:
city: Beijing
country: China
facility: State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC
Study officials:
affiliation: State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC, Beijing, China
name: Guyan Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07012616: Supraclavicular Brachial Plexus Block as Opioid Sparing Technique in Pediatrics Undergoing Arteriovenous Fistula Creation
Official title: Supraclavicular Brachial Plexus Block as Opioid Sparing Technique in Pediatrics Undergoing Arteriovenous Fistula Creation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Supraclavicular Brachial Plexus Block
Opioid Sparing
Pediatric
Arteriovenous Fistula
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy of supraclavicular brachial plexus block as an opioid-sparing technique in pediatric patients undergoing arteriovenous fistula creation.

Detailed description: The global incidence of end-stage renal failure (ESRF) is increasing. The preferred procedure for patients with ESRF undergoing maintenance Haemodialysis (HD) is the placement of an arteriovenous fistula (AVF).

In patients with ESRF, brachial plexus block (BPB) is frequently employed to administer anesthesia for the establishment or modification of AVF. This technique offers pain relief, sympathetic blockade, ideal surgical conditions, and a sufficient duration of postoperative block, preventing arterial spasms and graft thrombosis

Eligibility criteria: Inclusion Criteria:

* Age from 6 to 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I- III.
* Undergoing arteriovenous fistula creation under general anesthesia.

Exclusion Criteria:

* Allergy to local anesthetics.
* Infection at the site of block.
* Local infection.
* Coagulation disorder.
* Previously failed or revision of blocked arteriovenous fistula.

Primary outcomes:
measure: Intraoperative fentanyl consumption
timeFrame: Intraoperatively
Secondary outcomes:
measure: Total opioid consumption
timeFrame: 24 hours postoperatively
measure: Time to the 1st rescue analgesia
timeFrame: 24 hours postoperatively
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Patient satisfaction
timeFrame: 24 hours postoperatively
measure: Incidence of adverse events
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References: