louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03120416: Resistance Exercise Training in Chronic Kidney Disease
Official title: Effect of Resistance Exercise Training on Endothelial Function and Cardiovascular Risk Factors in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-04-19
Enrollment: 34
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aim to evaluate the feasibility of a resistance exercise training program among individuals with CKD and its impact on endothelial and vascular function.

Detailed description: Resistance exercise training has been shown to improve cardiovascular health including endothelial function in general populations, but studies in patients with chronic kidney disease (CKD) are limited. The investigators aim to evaluate the feasibility and acceptability of a resistance exercise training program among individuals with CKD and its impact on endothelial and vascular function as measured by brachial artery flow-mediated dilation, pulse-wave velocity and carotid artery stiffness. To accomplish this goal the investigators propose to conduct a 12-week pilot randomized controlled trial of twice a week resistance exercise training among 32 adults with CKD. The results of this study will inform the design and implementation of a larger trial evaluating the impact of resistance exercise training on adverse outcomes in patients with CKD including CKD progression.

Eligibility criteria: Inclusion Criteria:

* CKD stage 3 or 4 (eGFR 15-60 ml/min/1.73m2)

Exclusion Criteria:

* Currently institutionalized
* Kidney transplant or dialysis
* NY Heart Association class 3-4 heart failure
* Dementia or cognitive impairment
* Unstable angina or coronary revascularization within the last 3 months
* Uncontrolled arrhythmia
* Severe chronic lung disease
* Orthopedic, neurologic or other condition that would preclude resistance exercise training
* Pregnancy
* Uncontrolled hypertension (systolic \> 160 mmHg and diastolic \>90 mmHg)

Primary outcomes:
measure: Endothelial function
timeFrame: 3 months
Secondary outcomes:
measure: Vascular function
timeFrame: 3 months
measure: Carotid artery stiffness
timeFrame: 3 months
measure: Self-reported physical activity
timeFrame: 3 months
measure: Objectively measured physical activity
timeFrame: 3 months
measure: Systolic blood pressure
timeFrame: 3 months
measure: Serum LDL-cholesterol
timeFrame: 3 months
measure: Serum HDL-cholesterol
timeFrame: 3 months
measure: Muscle strength
timeFrame: 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: Assistant Professor of Medicine
name: Ana C Ricardo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02427516: Cost of Monitoring Patients Treated With Vitamin K Antagonists in Spain
Official title: Cost of Monitoring Patients Treated With Vitamin K Antagonists in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Badalona Serveis Assistencials
name: IMS Health
First posted: 2015-04-28
Enrollment: 1144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with NVAF or VTE and treated with VKA

Brief summary: To estimate annualized total cost rates (i.e. direct medical costs from hospitalizations, consultations, medications, and tests) of adequately controlling a patient (i.e. INR between 2-3 and TTR≥ 60%) diagnosed with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE), and treated with vitamin K antagonists (VKA) in Spain.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Patients aged 18 or older over the study period
* Patients with a diagnosis for NVAF or VTE anytime in their medical records
* Patients having at least one year of enrolment in the database prior to the index date
* Patients newly initiated with VKA during the study period (index date)

Exclusion Criteria:

* Patients with a diagnosis for both NVAF and VTE anytime in their medical records

Primary outcomes:
measure: Annualized total and per patient cost of patients diagnosed with NVAF or VTE treated with VKA and according to coagulation control status based on electronic clinical records
timeFrame: Approximately 60 months
Secondary outcomes:
measure: Demographic and clinical characteristics for all patients diagnosed with NVAF or VTE treated with VKA and according to coagulation control status based on electronic clinical records
timeFrame: Approximately 60 months
measure: Healthcare resource rates for all patients diagnosed with NVAF or VTE treated with VKA and according to coagulation control status based on electronic clinical records
timeFrame: Approximately 60 months
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05661916: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALN-TTRSC04 in Healthy Subjects
Official title: A Phase 1, Randomized, Double-Blind, Placebo Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Subcutaneously Administered ALN-TTRSC04 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Transthyretin-Mediated Amyloidosis
Keywords: ATTR amyloidosis
siRNA
Lead sponsor: Alnylam Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-12-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of single ascending doses of ALN-TTRSC04.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) ≥18.0 kg/m\^2 and ≤30 kg/m\^2 assessed at Screening.

Exclusion Criteria:

* Has an estimated glomerular filtration rate (eGFR) \<90 mL/min/1.73m\^2 at screening.
* Has alanine aminotransferase (ALT), aspartate aminotransferase (AST) or direct bilirubin above the upper limit of normal (ULN).

Primary outcomes:
measure: Frequency of Adverse Events
timeFrame: Up to 20 months
Secondary outcomes:
measure: Change from Baseline in Serum Transthyretin (TTR) Levels Over Time
timeFrame: Up to 18 months
measure: Maximum Observed Plasma Concentration (Cmax) of ALN-TTRSC04
timeFrame: Day 1 up to Day 4
measure: Time to Maximum Observed Plasma Concentration (Tmax) of ALN-TTRSC04
timeFrame: Day 1 up to Day 4
measure: Area Under the Concentration-time Curve (AUC) of ALN-TTRSC04
timeFrame: Day 1 up to Day 4
measure: Fraction of ALN-TTRSC04 Excreted in the Urine (fe)
timeFrame: Up to Day 2
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Clinical Trial Site
Study officials:
affiliation: Alnylam Pharmaceuticals Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05153616: Periodic Limb Movements Among Dialysis and Non-dialysis Chronic Kidney Disease Patients
Official title: Periodic Limb Movements Among Dialysis and Non-dialysis Chronic Kidney Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Aim of the Study Was to Screen Prevalence of Periodic Limb Movements Among Chronic Kidney Disease Patients
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Periodic leg movement disorder is defined as periodic episodes of repetitive limb movements during sleep that mainly occur in the lower limb, including the hips, knees and toes and sometimes affects the upper limb. It may be accompanied by frequent nocturnal arousals, and if so, this sleep disturbance may cause excessive daytime sleepiness. Chronic kidney disease patients are at risk of periodic leg movements and common causes are iron deficiency, anemia, raised serum calcium and central and peripheral nervous system disorders.


Eligibility criteria: Inclusion Criteria:

* chronic kidney disease

Exclusion Criteria:

* diabetic, hepatic and chrest disease patients

Primary outcomes:
measure: Periodic limb movement
timeFrame: One night
Secondary outcomes:
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
References:
Clinical trial NCT05069116: The Impact of Covid 19 Pandemic on the Training of General Surgery Residents
Official title: The Impact of Covid 19 Pandemic on the Training of General Surgery Residents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Pandemic
Educational Problems
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: general surgery resident doctors

Brief summary: The educational process of general surgery residents is a very important step in every surgeon's career, which is often overlooked or neglected. The Covid-19 pandemic has inflicted deep changes in the medical activity in general and in the training process of young doctors in particular.

Our study aims to assess the impact of the Covid-19 pandemic on the educational process of general surgery residents, through a comparative study. The responses of resident doctors at a questionnaire, in two different time periods, will be compared: pre-Covid era (December 2019) and Covid era (December 2020).


Eligibility criteria: Inclusion Criteria:

* General surgery residents
* Above second year of residency
* Residency program in Cluj-Napoca Medical Centre

Exclusion Criteria:

* Incomplete responses to the questionnaire
* Refusal to be included in the study

Primary outcomes:
measure: The impact of the pandemic on the educational process
timeFrame: December 2019-December 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: "Iuliu Haţieganu" University of Medicine and Pharmacy
Study officials:
References:
Clinical trial NCT01238016: Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - a Pilot Study
Official title: Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - a Pilot Study - A One Month Non-controlled Observational Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypoglycemia
Lead sponsor: UNEEG Medical A/S
Sponsor class: INDUSTRY
First posted: 2010-11-10
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The trial aims at measuring the safety and performance of the Hyposafe device.

Detailed description: Safety: To evaluate safety issues related to implantation and use of the Hyposafe hypoglycaemia alarm device Performance: To evaluate the stability of the hypoglycaemia alarm device.

Eligibility criteria: Inclusion Criteria:

Healthy control subjects or and

* Male and female patient with type 1 diabetes for at least one year
* Age 18-70 years
* Impaired awareness of hypoglycaemia as defined by

  * A score of ≥4 on the Gold-scale or
  * Two or more occasions of severe hypoglycaemia (need of help from third person) within the past 12 month
* Multiple injection insulin therapy or continuous insulin injection therapy
* For female participants: Not pregnant and, if child bearing potential, usage of reliable anti-contraceptive method during the study period

Exclusion Criteria:

* Severe cardiac disease

  * History of myocardial infarction
  * Cardiac arrhythmia
* Previous stroke or cerebral haemorrhage and any other structural cerebral disease
* Active cancer or cancer diagnosis within the past five years
* Uremia defined as s-creatinine above 3 times upper reference value
* Liver disease defined as s-ALAT above 3 times upper reference interval
* Inability to understand the informed consent
* Epilepsy
* Use of antiepileptic drugs for any purposes
* Clinical important hearing impairment
* Use of active implantable medical device including

  * Pacemaker and ICD-unit
  * Cochlear implant
* Use of following drugs

  * Chemotherapeutic drugs of any kind
  * Methotrexate
  * Third generation antipsychotic drugs (aripiprazole, quetiapine, clozapine, ziprasidone, paliperidone, risperidone, sertindole, amisulpride, olanzapine)
* Abuse of alcohol (defined as consumption of \> 250g alcohol (in Danish: 21 "genstande") per week or abuse of any other neuroactive substances
* Infection at the site of device-implantation
* Any hemorrhagic disease
* Diving (snorkel diving allowed) or parachute jumping
* Patients that are judged incapable of understanding the patient information or who are not capable of carrying through the investigation

Primary outcomes:
measure: Device performance
timeFrame: End of observation
Secondary outcomes:
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Esbjerg Sygehus
Study officials:
References:
Clinical trial NCT01876316: The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects
Official title: A Randomized, Double-blind, Placebo-controlled, Two-way Crossover Trial to Compare Moxifloxacin Induced QT Interval Prolongation in Japanese and Korean Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Moxifloxacin
QT interval prolongation
Korean
Japanese
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects

Detailed description: The purpose of this study is to explore the ethnic and gender difference in the Moxifloxacin induced QT interval prolongation between Japanese and Korean subjects.

Eligibility criteria: Inclusion Criteria:

- 1) Subjects in Japan and Korea deemed healthy as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, or clinical laboratory determinations.

2) Body Mass Index (BMI) of 17.6 to 26.4 kg/m2, BMI = weight (kg)/ \[height (m)\]2.

Exclusion Criteria:

* 1) Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.

  2) Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat.
* Heart rate ≤ 45 bpmmsec or Heart rate ≥ 100 bpmmsec
* PR ≥ 210 msec
* QRS ≥ 120 msec
* QT ≥ 500 msec
* QTcF: male ≥ 450 msec, female ≥470msec
* Iincomplete right bundle branch block
* Marked Sinus Arrhythmia
* Wondering pacemaker
* Atrial rhythm

Primary outcomes:
measure: double delta QTcF
timeFrame: up to 24 hours
Secondary outcomes:
measure: double delta QTcI, double delta QTcSS
timeFrame: up to 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Inje University
name: Jae-Gook Shin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choi HK, Jung JA, Fujita T, Amano H, Ghim JL, Lee DH, Tabata K, Song ID, Maeda M, Kumagai Y, Mendzelevski B, Shin JG. Population Pharmacokinetic-Pharmacodynamic Analysis to Compare the Effect of Moxifloxacin on QT Interval Prolongation Between Healthy Korean and Japanese Subjects. Clin Ther. 2016 Dec;38(12):2610-2621. doi: 10.1016/j.clinthera.2016.10.011.
Clinical trial NCT01977716: Peritonitis and Loss of Residual Renal Function, Technique Failure and Mortality in Peritoneal Dialysis Patients
Official title: The Role of Peritonitis in the Loss of Residual Renal Function, Technique Failure and Mortality in Peritoneal Dialysis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Loss of Residual Renal Function
Technique Failure in Peritoneal Dialysis
Keywords: Peritonitis
loss of residual renal function
technique survival
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2013-11-07
Enrollment: 350
Sex: ALL
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: All patients starting PD as the first dialysis treatment will be considered. Recruitment will take place over a six-months period in hospitals belonging to the Instituto Mexicano de Seguro Social. Inclusion criteria include: adult patients with signed informed consent given; there should not be selection for age, gender, primary cause of renal disease. Patients will not be included if they were previously in hemodialysis or received renal transplant. Patients will also be excluded if they are on immunosuppressive therapy, have diagnosis of cancer, or are seropositive for HIV or hepatitis.

Brief summary: The primary objective is to analyze peritonitis rate and peritonitis bacteriology as risk factors for loss of residual renal function, technique failure and mortality in chronic kidney disease patients.

Secondary objectives are: To know the current rate of peritonitis in peritoneal dialysis population and to understand the bacteriological profile of peritonitis.

To know the rate and risk factors other than peritonitis involved in the loss of residual renal function.

To analyze the utility of alternative diagnostic tests, such as reagent strips, for early detection of peritonitis when traditional tests are not available.

To analyze the simultaneous measurement of serum creatinine and cystatin-C as alternative measurements of peritoneal clearance and residual renal function.


Eligibility criteria: Inclusion Criteria:Inclusion criteria include: adult patients with signed informed consent given; there should not be selection for age, gender, primary cause of renal disease.

-

Exclusion Criteria:Patients will not be included if they were previously in hemodialysis or received renal transplant. Patients will also be excluded if they are on immunosuppressive therapy, have diagnosis of cancer, or are seropositive for HIV or hepatitis.

-

Primary outcomes:
measure: Loss of residual renal function
timeFrame: 25 months
measure: Technique (peritoneal dialysis) failure
timeFrame: 25 months
Secondary outcomes:
Other outcomes:
measure: Death
timeFrame: 25 months
Locations:
city: Mexico City
country: Mexico
facility: Unidad de Investigación Médica en Enfermedades Nefrológicas, Instituto Mexicano del Seguro Social
state: DF
Study officials:
References:
Clinical trial NCT01106716: Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Postherpetic Neuralgia
Official title: A Double-Blind, Randomized, Placebo- and Active-Comparator-Controlled, Single-Dose Study to Assess the Efficacy of KAI-1678 Administered by Subcutaneous Infusion in Subjects With Postherpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postherpetic Neuralgia
Keywords: Lidocaine
Lignocaine
Analgesics. Non-narcotic / therapeutic use
Neuralgia, Postherpetic
Pain
Pain measurement / drug effect
Pain postoperative / drug therapy
PHN
Lead sponsor: KAI Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Trident Clinical Research Pty Ltd
First posted: 2010-04-20
Enrollment: 23
Sex: ALL
Minimum age (years): 18
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 determine whether KAI-1678 is effective in the treatment of postherpetic neuralgia pain


Eligibility criteria: Inclusion Criteria:

* diagnosis of PHN with pain for at least 3 months after segmental herpes zoster eruption
* pain score at least 4 on 11-point numerical rating scale (0-10)
* stable doses of analgesic medications for at least 1 month"

Exclusion Criteria:

* diagnosis of PHN with pain for at least 3 months after segmental herpes zoster eruption
* pain score at least 4 on 11-point numerical rating scale (0-10)
* stable doses of analgesic medications for at least 1 month"

Primary outcomes:
measure: The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6).
timeFrame: Day 1
Secondary outcomes:
measure: The effect of KAI-1678 on the proportion of subjects achieving at least a 1 point improvement in pain intensity at 6 hours
timeFrame: Day 1
measure: The effect of KAI-1678 on patient global response to treatment
timeFrame: Day 1
measure: The effect of KAI-1678 on symptoms associated with PHN assessed by the Neuropathic Pain Scale (NPS)
timeFrame: Day 1
measure: The number of adverse events as a measure of safety and tolerability of KAI-1678
timeFrame: Two weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
state: New South Wales
Study officials:
affiliation: KAI Pharmaceuticals, Inc
name: Gregory Bell, MD
role: STUDY_DIRECTOR
References: