louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04650607: Phage Safety Cohort Study
Official title: Phage Safety Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prosthetic Joint Infection
Severe Infection
Keywords: phage
adverse event
severe infection
compassionate treatment
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 100
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: patients having a severe infection treated by injection of phages at the CRIOAC Lyon, Croix-Rousse Hospital

Brief summary: This cohort study aims to describe the adverse events related to the use of bacteriophages to treat serious infections, data from the literature being almost non-existent on this subject.

Detailed description: All potential serious adverse events in compassionate cases will be collected, and classified as potentially related to surgery, to antibiotics, or to phages, with the help of the HCL pharmacovigilance center. In addition, biobanking of pre- and post-treatment blood specimens (bloods, serums and cells) will determine whether phage immunization is implicated in particular adverse events.

Eligibility criteria: Inclusion Criteria:

* Patient 18 years of age or older with a serious infection treated at CRIOAc Lyon by phage therapy
* Patient who did not object to participating in the study
* Patients ayant un poids minimum de 46kg

Exclusion Criteria:

* Patients under guardianship/curatorship
* Patients deprived of liberty
* Pregnant or breastfeeding women

Primary outcomes:
measure: type of adverse event
timeFrame: 12 months after the injection of phages
measure: rate of adverse event
timeFrame: 12 months after the injection of phages
Secondary outcomes:
measure: biobanking PHA SA CO
timeFrame: from before the injection of phages to 6 months after the injection of phages
measure: biobanking PhageRESPONSE
timeFrame: from before the injection of phages to 6 months after the injection of phages
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT00961207: Triple Blockade of the Renin Angiotensin Aldosterone System in Diabetic (Type 1&2) Proteinuric Patients
Official title: Study of Triple Blockade of the Renin Angiotensin Aldosterone System (RAAS) in Diabetic (Type 1&2) Proteinuric Patients With (ACE-, ARB, DRI)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Microalbuminuria
Macroalbuminuric Diabetic Nephropathy
Diabetes
Proteinuria
Albuminuria
Lead sponsor: Cook County Health
Sponsor class: OTHER_GOV
First posted: 2009-08-18
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study Hypothesis:

Reduction in albuminuria has been shown to decrease progression of diabetic

nephropathy. In diabetic nephropathy patients treated with maximal

antihypertensive doses with dual RAAS blockade (total daily dose valsartan 320

mg and either enalapril 40 mg or benazepril 40 mg daily, or losartan 100mg), persistent

albuminuria reflects further additional RAAS activation. Microvascular renal

disease due to increased RAAS activation may be more effectively treated with

triple blockade by the addition of a direct renin inhibitor (DRI) Aliskiren.


Eligibility criteria: Inclusion Criteria:

* Macroalbuminuria \> 300mg/g
* Microalbuminuria 30-300mg/g
* Stable on max dose of an ACE-I or ARB (Can also be titrated to max dosage of ACE-I and ARB and stable on those doses for at least 2 weeks)
* Blood pressure \<130/80 mm Hg at time of enrollment
* Diabetic either Type 1 or 2

Exclusion Criteria:

* GFR \<60 m/min
* Potassium \> 5mg/dl at time of enrollment
* Pregnant
* History of Angioedema
* ACE-I cough
* Allergic to ARB, ACE-I, DRI
* A1C \> 9%

Primary outcomes:
measure: Reduction in albuminuria/proteinuria
timeFrame: 6 weeks
Secondary outcomes:
measure: Safety of Triple RAAS inhibition with ACE-I, ARB and DRI
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: John H Stroger Hospital of Cook County
state: Illinois
Study officials:
affiliation: Cook County Health
name: Pete Antonopoulos, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04129307: Brain Training Tools With Physical Practice on Motor Learning
Official title: Assessment of the Effects of Brain Training Tools in Combination With Physical Practice on the Acquisition of Different Motor Tasks: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Motor Learning
Keywords: Motor imagery
Action observation
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
Collaborators: name: Centro Universitario La Salle
First posted: 2019-10-16
Enrollment: 45
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: BASIC_SCIENCE

Brief summary: This study evaluates the influence of motor imagery and action observation in combination with physical practice on motor learning


Eligibility criteria: Inclusion Criteria:

* asymptomatic subjects
* men and women between 18 and 65 years of age
* participants with no systemic, neurological, cognitive or psychological disease.

Exclusion Criteria:

* underage participants
* presence of systemic pathology, pain and/or weakness that prevents the protocol
* participants who have undergone an operation in the spine.

Primary outcomes:
measure: Hit ratio in a manual skill test
timeFrame: Change from hit ratio in a manual skill at 1 week
measure: Free basketball shots
timeFrame: Change from hit ratio in free throws at 1 week
measure: Standing jump
timeFrame: Change from distance at 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU La Salle
Study officials:
References:
Clinical trial NCT00712907: Effects of Vitamin C on Hyperoxia-Induced Reduction of Retinal Blood Flow
Official title: Effects of Vitamin C on Hyperoxia-Induced Reduction of Retinal Blood Flow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ocular Physiology
Regional Blood Flow
Keywords: vitamin C
retinal blood flow
intraocular pressure
retinal vessel diameter
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-07-10
Enrollment: 12
Sex: MALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: High arterial blood oxygen tension leads to vasoconstriction of retinal vessels, possibly related to an interaction between reactive oxygen species and endothelium-derived vasoactive factors. Vitamin C is a potent antioxidant capable of reversing endothelial dysfunction due to increased oxidant stress. Vitamin C appears to have vasodilatory properties, but the underlying mechanisms are not well understood.

In the present study we hypothesized that hyperoxic vasoconstriction of retinal vessels could be diminished by vitamin C.

Ocular blood flow will be determined by non-invasive methods, including laser Doppler velocimetry and the Zeiss retinal vessel analyser.


Eligibility criteria: Inclusion Criteria:

* Men aged between 19 and 35 years, nonsmokers
* Body mass index between 15th and 85th percentile (Must A 1991)
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 3 Dpt.

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks

Primary outcomes:
measure: Retinal arterial and venous diameter (Zeiss retinal vessel analyzer)
timeFrame: in total 6 hours
measure: Retinal blood flow velocity (laser Doppler velocimetry)
timeFrame: in total 6 hours
measure: Intraocular pressure (applanation tonometry)
timeFrame: in total 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology
Study officials:
References:
Clinical trial NCT00463307: Evaluation of the Use of a Urin Test Strip to Determine the Spread of Schistosoma Infections in Areas Where Schistosomiasis Infections Are Low in Kenya
Official title: Evaluation of Applicability of Urine Based Schistosomiasis Test Strip in the Epidemiologic Mapping and Sampling of Schistosoma Mansoni Infection in Low Endemic Areas of Kenya
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schistosomiasis Mansoni
Circulating Cathodic Antigen Urine Based Dipstick
Keywords: schistosomiasis
Schistosoma mansoni
Circulating cathodic antigen urine dipstick
Lead sponsor: DBL -Institute for Health Research and Development
Sponsor class: OTHER
First posted: 2007-04-20
Enrollment: 1100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to evaluate the use of a urine test strip in diagnose schistosoma mansoni in areas of Kenya where the rate of infections are low.

The hypothesis is that the urine strip test is a superior tool to the conventional parasitological tools used to diagnose schistosomiasis mansoni infections in area where there is low transmission

Detailed description: The study will compare the use of the urine test strip with the conventional method used and with a "golden standard" methode, in an area of Kenya where the infection transmission is low. Furthermore will the urine test strip be evaluatied in its ability to monitor the intensity of infections in school children before and after they are been treated for the infections.

A total of 1100 school children in the age between 10 and 18 years will be included in the study. Children have to submitt a stool and a urine sample on three consecutive days. Children who are found to be infected with the schistosomiasis parasite will be offered treatment.

Eligibility criteria: Inclusion Criteria:

* Children in the age between 10 and 18 years

Exclusion Criteria:

* Children younger then 10 years of age and children whos parent/guardians did not give informed consents for their participation in the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Kenya Medical Research Institute
Study officials:
affiliation: Division of Vector Borne Diseases, Kenya
name: Hussein J Kihara, mr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03650907: Exercise Intervention for Patients With Sarcopenia or Frailty in Long-term Care Institutions
Official title: Exercise Intervention for Patients With Sarcopenia or Frailty in Long-term Care Institutions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sarcopenia is a geriatric syndrome of decreased muscle volume with muscular function decline. There is more tendency for sarcopenic elderly to be frail, disabled, or have cardiovascular disease. Compared to those who are not sarcopenic, they also had worse prognosis in response to treatment for definite diseases, and spend more medical cost.

Exercise appears to have an important role in management of sarcopenia. In the current study, the investigators provide an exercise program, including resistance/balance training for the elderly with sarcopenia or frailty in long-term care institution, and evaluate the effect.


Eligibility criteria: Inclusion Criteria:

1. \>20-year-old
2. diagnosed with sarcopenia (by the definition from Asia workgroup for sarcopenia, AWGS) or frailty (The Fried model, based on five functional criteria)

Exclusion Criteria:

1. Severe medical diseases or mental problems, which result in difficulty to follow exercise program.
2. Inability to get down from bed for activity due to disease, such as neuropathy or orthopedic disease.
3. High risk group for exercise program, such as those with unstable fracture or nonunion fracture.
4. Anyone who didn't want attend this study.

Primary outcomes:
measure: Muscle strength
timeFrame: after 16-weeks training
measure: walk speed
timeFrame: after 16-weeks training
Secondary outcomes:
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Bor-Ay Sweet home
Study officials:
affiliation: Chang Gung Medical Hospital
name: Wen-Chun Tseng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00387907: Study of Larotaxel in Combination With Weekly Herceptin® in Patients With HER2 Positive Metastatic Breast Cancer
Official title: Open Label, Uncontrolled, Study of XRP9881 (Larotaxel) in Combination With Weekly Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Breast Cancer
Breast Cancer
Metastatic Breast Cancer
Keywords: Herceptin
Taxane
Breast Cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-10-13
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the anti-tumor activity of the combination of experimental drug (larotaxel) when combined with Herceptin® in patients with advanced breast cancer. Anti-tumor activity will be determined by looking at changes in tumor size on CT or MRI scans. Additional goals of this study are to look at patient safety, to determine how long the study drugs (larotaxel and Herceptin®) stay in the patient's body and what effects the study medications may have on each other, and to find out how long patients remain cancer free on this study treatment.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of breast cancer
* Evidence that cancer has spread beyond its original location or has come back and cannot be removed by surgery
* No more than one prior treatment for advanced disease
* Her2 positive status
* Adequate liver and kidney function
* No remaining severe harmful effects to prior treatments

Exclusion Criteria:

* Certain heart condition
* Pregnant Women
* History of another cancer except some skin cancers and cervical cancer
* Taking other treatments for your cancer at the time you enter the trial

Primary outcomes:
measure: Tumor response measured
timeFrame: every 2 cycles during treatment phase
Secondary outcomes:
measure: Progression Free Survival and Overall Survival
timeFrame: measured every 3 weeks during study treatment, then every 6 weeks after a patient has stopped the study treatment until the patient's cancer worsens, then every 3 months
Other outcomes:
Locations:
city: Malvern
country: United States
facility: Sanofi-Aventis Administrative Office
state: Pennsylvania
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Eric Winer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01829607: Functional Electrical Stimulation of Peripheral Muscles in Heart Failure With Preserved Left Ventricular Ejection Fraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure With Preserved Left Ventricular Ejection Fraction
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 30
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: The purpose of this study is to evaluate the effects of functional electrical stimulation of peripheral muscles on clinical and emotional status, endothelial function and left ventricular diastolic function in heart failure with preserved left ventricular ejection fraction.


Eligibility criteria: Inclusion Criteria:

(i) symptoms \[New York Heart Association (NYHA) class II or III\] and signs typical of heart failure

(ii) left ventricular (LV) ejection fraction (LVEF) \>50% and LV end-diastolic volume index \<97 mL/m2

(iii) findings of left atrial (LA) dilatation (LA volume index \>40mL/m2), LV hypertrophy and/or LV diastolic dysfunction \[ie, mitral E/A ratio \<1 or \>2, mitral E/e' ratio \>15 or 8-15, (A pulmonary - A mitral) duration difference \>30 ms etc)

(iv) no alterations in medical therapy during the previous 4 weeks

(v) no myocardial infarction within 3 months prior to enrollment

Exclusion Criteria:

recent (≤4 weeks) heart failure decompensation

* acute coronary syndrome
* chronic inflammatory diseases and malignancies

Primary outcomes:
measure: Exercise capacity
timeFrame: Six weeks
measure: Quality of life
timeFrame: Six weeks
measure: Emotional status
timeFrame: Six weeks
Secondary outcomes:
measure: Left ventricular diastolic function
timeFrame: Six weeks
measure: Endothelial function
timeFrame: Six weeks
Other outcomes:
measure: Neurohormonal activation
timeFrame: Six weeks
Locations:
city: Athens
country: Greece
facility: Attikon University Hospital
Study officials:
References:
citation: Karavidas A, Driva M, Parissis JT, Farmakis D, Mantzaraki V, Varounis C, Paraskevaidis I, Ikonomidis I, Pirgakis V, Anastasiou-Nana M, Filippatos G. Functional electrical stimulation of peripheral muscles improves endothelial function and clinical and emotional status in heart failure patients with preserved left ventricular ejection fraction. Am Heart J. 2013 Oct;166(4):760-7. doi: 10.1016/j.ahj.2013.06.021. Epub 2013 Aug 30.
Clinical trial NCT01830907: Efficacy of Preoperative Nutritional Support on Postoperative Outcome in Gastric Cancer Patients at Nutritional Risk by NRS-2002
Official title: Efficacy of Preoperative Nutritional Support on Postoperative Outcome in Gastric Cancer Patients at Nutritional Risk by NRS-2002- A Prospective, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Malnutrition
Gastric Cancer
Keywords: Malnutrition
Gastric cancer
preoperative nutrition
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2013-04-12
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the impact of preoperative nutritional support on clinical outcomes in patients at nutritional risk. The primary endpoint was the complication rate and the second endpoint was the length of stay.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of gastric cancer surgery preoperative stage

Exclusion Criteria:

* neoadjuvent chemoradiation
* pregnant
* advanced stage

Primary outcomes:
measure: Infectious complication
timeFrame: 30 days
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Changchun
country: China
facility: First hospital of Jilin University
state: Jilin
Study officials:
References:
citation: van Stijn MF, Korkic-Halilovic I, Bakker MS, van der Ploeg T, van Leeuwen PA, Houdijk AP. Preoperative nutrition status and postoperative outcome in elderly general surgery patients: a systematic review. JPEN J Parenter Enteral Nutr. 2013 Jan;37(1):37-43. doi: 10.1177/0148607112445900. Epub 2012 May 1.
Clinical trial NCT00811707: Epidural Sonoanatomy Between Parturient and Non-Pregnant
Official title: To Compare Epidural Sonoanatomy Between Parturient and Non-Pregnant Young Female in Chinese Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parturients
Keywords: ultrasound image
epidural space
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2008-12-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: from Kaohsiung Medical University Hospiral ward parturients

Brief summary: The failure in indwelling epidural catheter for a parturient might cause an anesthetic difficulty. Furthermore, no one can predict the accuracy of needle placement prior to skin puncture with any of landmark-based technique. This may result in multiple trying attempts at needle puncture, pain and discomforts of patients and poor patient satisfaction. The aim of this study was to explore the difference of epidural space between parturient and non-pregnant women by assessing ultrasound image.

Detailed description: We will enroll 30 non-pregnant female volunteers and 30 parturients(ASA I-III) underwent epidural blocks. A low frequency ultrasound (2-5 MHz) with a curved array transducer is used to obtain spinal sonography for each subject. The paramedian axis was used to obtain optimal ultrasound image for spinal sonography. Outcome was evaluated by the diameter and depth of epidural space at three lumbar interspaces. Paired T-test was carried out to evaluate the statistical significance of epidual diameter and depth.

Eligibility criteria: Inclusion Criteria:

* parturients scheduled to receive lumbar epidurals for elective cesaeran delivery labor analgesia

Exclusion Criteria:

* Pregancy induced hypertension gestational Diabetes patients who refuse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Hospital
Study officials:
References: