louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02897713: Feasibility, Safety, and Outcomes of Intensive Enteral Nutrition in Patients With Mechanical Ventilation
Official title: Feasibility, Safety and Outcomes of Intensive Enteral Nutrition in Mechanical-ventilated Patients: a Multicenter, Parallel Randomized Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Critical Illness
Keywords: mechanical ventilation
enteral nutrition
feeding intolerance
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai 6th People's Hospital
name: Shanghai Tongji Hospital, Tongji University School of Medicine
name: Shanghai 10th People's Hospital
name: Shanghai Jinshan Hospital
name: Shanghai Minhang Central Hospital
name: RenJi Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Shanghai East Hospital
name: Xuhui Central Hospital, Shanghai
name: Shanghai Tong Ren Hospital
First posted: 2016-09-13
Enrollment: 400
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: Patients with mechanical ventilation are in risk of malnutrition, which could lead to worse outcome. According to guidelines released from authority organizations, enteral nutrition (EN) should be prior approach for critically ill patients. However, initiation and delivery of EN during the early period of ICU admission are frequently hampered, which results in underfeeding. The investigators speculate whether an intensive enteral nutrition strategy could reinforce the delivery of EN thereby improving outcomes. In this multi-center, prospective, randomized parallel clinical trial, the investigators aim to assess the feasibility, safety and outcomes of intensive enteral nutrition in mechanical-ventilated patients.


Eligibility criteria: Inclusion Criteria:

* predicted time of mechanical ventilation more than 48 hours

Exclusion Criteria:

* no enteral nutrition pathway
* refuse to informal consent
* surgeon refuse the protocol
* palliative care

Primary outcomes:
measure: Incidence rate of hospital-acquired infections
timeFrame: 28 days after ICU admission
Secondary outcomes:
measure: mortality of 28 days
timeFrame: 28 days after ICU admission
measure: ICU stay
timeFrame: from ICU admission to timepoint of patient's discharge or death, up to 12 months
measure: free days of mechanical ventilation
timeFrame: during whole ICU stay, up to 12 months
measure: rate of reaching 80% of energy target during 72 hours
timeFrame: first 72 hours after ICU admission
measure: EN-associated adverse events
timeFrame: during whole ICU stay, up to 12 months
measure: rate of parenteral nutrition delivery
timeFrame: during whole ICU stay, up to 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
Study officials:
affiliation: Fudan University
name: Duming Zhu, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT01827813: Comparison Of Effectiveness of Transrectal Ultrasonography-Guided Saturation Biopsy And 10-12 Core Biopsy In Repeated Prostate Biopsies
Official title: Comparison Of Effectiveness of Transrectal Ultrasonography-Guided Saturation Biopsy And 10-12 Core Biopsy In Repeated Prostate Biopsies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate-specific antigen
digital rectal examination
transrectal ultrasonography
needle biopsy
prostate cancer
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2013-04-10
Enrollment: 74
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: OBJECTIVE To assessment the results of repeated saturation and 10-12 core biopsy protocols in patients with a negative initial biopsy but continued suspicion for prostate cancer MATERIALS AND METHOD Data of the patients who underwent prostate biopsy between June 2007 and June 2012 were retrospectively assessed. Patients with an abnormal digital examination findings and/or abnormal serum prostate specific antigen levels were biopsied. The indication for a repeated biopsy was determined as the continued suspicion for a malignancy after the initial benign biopsy result and/or a pathology result consistent with a high-grade prostatic intraepithelial neoplasia or atypical small acinar proliferation. Patients who underwent saturation and core 10-12 biopsies at repeated biopsies were compared. Statistical analyses were performed with Shapiro-Wilk test and Mann- Whitney U test. A p value less than 0.05 was accepted as statistically significant.


Eligibility criteria: Inclusion Criteria:

1. Abnormal digital examination
2. High serum prostate specific antigen (PSA) level.
3. The continued suspicion for a malignancy after the initial benign biopsy result and/or a pathology result consistent with a high-grade prostatic intraepithelial neoplasia (HGPIN) or atypical small acinar proliferation (ASAP).

Exclusion Criteria:

1. Patients with coagulopathies
2. Patients with unsuitable general conditions for prostate biopsy.

Primary outcomes:
measure: Detection rate of prostate cancer.
timeFrame: At least two months
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Department of Urology, Ercieys University, Faculty Of Medicine,
Study officials:
affiliation: Erciyes University, Faculty of Medicine
name: Abdullah Demirtas, Assistant Prof., MD
role: STUDY_DIRECTOR
affiliation: Erciyes University, Faculty of Medicine
name: Akın Avcı, Resident in UrologyMD,
role: PRINCIPAL_INVESTIGATOR
affiliation: Erciyes University, Faculty of Medicine
name: Ibrahim Gulmez, Professor in Urology,M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT04373213: Evaluation of the Fluid Response of SARS-CoV-2 (COVID-19) Patients in Intensive Care; Pleth Variability Index
Official title: Evaluation of the Fluid Response of SARS-CoV-2 (COVID-19) Patients in Intensive Care; Pleth Variability Index
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pleth Variability Index
Lead sponsor: Erzincan University
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years of age who have been hospitalized in the COVID 19 anesthesia intensive care unit

Brief summary: In this study; We aimed to investigate the role of pleth variability index, which is a noninvasive method, in showing fluid response in SARS-CoV-2 (COVID-19) patients, which we know is appropriate fluid management.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized in COVID 19 anesthesia intensive care unit
* Patients over the age of 18

Exclusion Criteria:

* Patients under the age of 18

Primary outcomes:
measure: Pleth variability index
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Erzincan
country: Turkey
facility: Erzincan University
Study officials:
affiliation: Dr.
name: ILKE KUPELI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Basso F, Berdin G, Virzi GM, Mason G, Piccinni P, Day S, Cruz DN, Wjewodzka M, Giuliani A, Brendolan A, Ronco C. Fluid management in the intensive care unit: bioelectrical impedance vector analysis as a tool to assess hydration status and optimal fluid balance in critically ill patients. Blood Purif. 2013;36(3-4):192-9. doi: 10.1159/000356366. Epub 2013 Dec 20.
citation: Claure-Del Granado R, Mehta RL. Fluid overload in the ICU: evaluation and management. BMC Nephrol. 2016 Aug 2;17(1):109. doi: 10.1186/s12882-016-0323-6.
citation: de Oliveira OH, Freitas FG, Ladeira RT, Fischer CH, Bafi AT, Azevedo LC, Machado FR. Comparison between respiratory changes in the inferior vena cava diameter and pulse pressure variation to predict fluid responsiveness in postoperative patients. J Crit Care. 2016 Aug;34:46-9. doi: 10.1016/j.jcrc.2016.03.017. Epub 2016 Mar 30.
citation: Piskin O, Oz II. Accuracy of pleth variability index compared with inferior vena cava diameter to predict fluid responsiveness in mechanically ventilated patients. Medicine (Baltimore). 2017 Nov;96(47):e8889. doi: 10.1097/MD.0000000000008889.
citation: Liu T, Xu C, Wang M, Niu Z, Qi D. Reliability of pleth variability index in predicting preload responsiveness of mechanically ventilated patients under various conditions: a systematic review and meta-analysis. BMC Anesthesiol. 2019 May 8;19(1):67. doi: 10.1186/s12871-019-0744-4.
Clinical trial NCT01773213: Detrusor Contraction During the Ice-water-test
Official title: Is the Detrusor Contraction During the Ice-water-test Provoked by the Ice Water or the Rapid Bladder Filling? A Randomized, Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Bladder, Neurogenic
Neuropathic Bladder
Keywords: Lower urinary tract
Bladder
Neuropathic bladder
Overactive bladder
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In this randomized, double-blind clinical trial including patients with a neurogenic lower urinary tract dysfunction undergoing urodynamic investigation at the Spinal Cord Injury Center, Balgrist University Hospital, Zürich, we aim to investigate whether the detrusor contraction during the ice-water-test is provoked by the ice water or the rapid filling.

Detailed description: The ice-water-test (IWT) was first described 1957 by Bors and Blinn and it was thought to differentiate between lesions of the upper and lower motoneuron. In cat studies, it was shown that the IWT is a C-fiber mediated lower motoneuron segmental reflex and that these unmyelinated C fibers are associated with cold receptors. This explains the positive IWT in patients with upper motoneuron lesions. In healthy humans, the IWT is positive up to the age of 4 years and becomes negative thereafter since the reflex is centrally inhibited. However, this reflex might be unmasked by a neurological disease and/or injury.

Considering that C-fibers are involved in the pathogenesis of detrusor overactivity, the IWT seems to be a useful diagnostic tool in daily practice. However, although there are many studies published on the IWT, it is unclear whether the detrusor contraction during the IWT is provoked by the ice water or whether it might be caused by the rapid filling. Therefore, we designed this randomized, double-blind trial.

Eligibility criteria: Inclusion Criteria:

* neurogenic lower urinary tract dysfunction
* urodynamic investigation
* written informed consent
* ≥ 18 years old

Exclusion Criteria:

* symptomatic urinary tract infection
* \< 18 years old
* ≥ 90 years old
* no written informed consent
* pregnancy

Primary outcomes:
measure: Increase of detrusor pressure in cmH20
timeFrame: 60 minutes
Secondary outcomes:
measure: Sensations (yes/no)
timeFrame: 60 minutes
measure: Urinary incontinence
timeFrame: 60 minutes
measure: Heart rate
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Neuro-Urology, Spinal Cord Injury Center & Research, Balgrist University Hospital
Study officials:
References:
Clinical trial NCT02188836: Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures
Official title: Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fracture, Closed, Comminuted, Healing
Lead sponsor: Fundacion Clinica Valle del Lili
Sponsor class: OTHER
First posted: 2014-07-14
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Electromagnetic device
Primary purpose: TREATMENT

Brief summary: This study specifically evaluates the effects of electromagnetic stimulation for diaphyseal femur fractures using a device developed by the investigators.

The hypothesis is that patients with femoral diaphysis treated with the electromagnetic stimulation have less non-union after six months than patients treated with a placebo device.

Detailed description: The inclusion criteria were: patients of any sex, age between 18 and 60 years, with a closed fracture in their femoral diaphysis or an open fracture secondary to a low-speed bullet; treated with open or closed reduction and intramedullary reamed blocked nail.

Patients were excluded if they had a pathological fracture, an open fracture from another etiology, or if they were treated after 10 days from the day of fracture.

64 patients were included.

Randomization took place six weeks after fracture day, allocating participants to either one of two groups: group A (electromagnetic stimulation) or group B (placebo).

Each group had a device exactly the same. Patients used the device during one hour every day for eight weeks.

Eligibility criteria: Inclusion Criteria:

* Patients of any sex,
* age between 18 and 60 years, with a closed fracture in their femoral diaphysis or an open fracture secondary to a low-speed bullet;
* treated with open or closed reduction and intramedullary reamed blocked nail.

Exclusion Criteria:

* Patients were excluded if they had a pathological fracture,
* an open fracture from another etiology, or if they were treated after 10 days from the day of fracture.

Primary outcomes:
measure: Fracture healing
timeFrame: up to 18 weerks
Secondary outcomes:
measure: Infection
timeFrame: 6 months
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Fundacion Valle del Lili
state: Valle
Study officials:
affiliation: Fundacion Clinica Valle del Lili
name: Alfredo Martinez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02963636: Proximity Work in Family Medicine Groups : the Impact of Pharmacists
Official title: Proximity Work in Family Medicine Groups : the Impact of Pharmacists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Services
Keywords: family medicine group
pharmacists
primary health care
pharmaceutical services
interprofessional relations
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: McGill University
name: Fonds de la Recherche en Santé du Québec
name: Université de Sherbrooke
First posted: 2016-11-15
Enrollment: 62
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The project objective is to evaluate the impact of the recent addition of pharmacists within family medicine groups (FMGs) on organizational and clinical parameters. The process by which changes occur and the level of pharmacists' activities will also be assessed. The ultimate goal of the project is the development of an accompanying guide to facilitate the work of the pharmacist in monitoring complex patients in primary care medical clinics.


Eligibility criteria: Inclusion Criteria:

* Willing to meet with the pharmacist and;
* Consuming drugs of four or more different pharmacological classes or having to take at least four doses per day and;
* aged 70 or over with at least two criteria of vulnerability or aged less than 70 with at least 3 criteria of vulnerability or had a recent loss of autonomy or in post- hospitalization with medication changes in the hospital.

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of drug related problems
timeFrame: 3 to 6 months
Secondary outcomes:
measure: Regimen complexity
timeFrame: 3 to 6 months
measure: Medication adherence
timeFrame: 3 to 6 months
measure: Quality of care provided by the clinical team (pharmacists, doctors, nurses, etc.)
timeFrame: 3 to 6 months
Other outcomes:
Locations:
city: Québec
country: Canada
facility: CIUSSS de la Capitale-Nationale
state: Quebec
Study officials:
References:
Clinical trial NCT00366236: Study of Nitazoxanide in the Treatment of Amebiasis in Adults and Adolescents
Official title: Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Tablets in the Treatment of Diarrhea Caused by Entamoeba Histolytica in Adults and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Amebiasis
Keywords: Amebiasis
Entamoeba histolytica
Lead sponsor: Romark Laboratories L.C.
Sponsor class: INDUSTRY
First posted: 2006-08-21
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of nitazoxanide tablets in treating diarrhea caused by Entamoeba histolytica in adults and adolescents.


Eligibility criteria: Inclusion Criteria:

* Age ≥12 years.
* Patients with diarrhea (≥3 bowel movements/day) with one or more enteric symptoms such as bloody stools, rectal bleeding or enlarged colon.
* Positive stool ELISA test for Entamoeba histolytica within 7 days prior to enrollment.

Exclusion Criteria:

* Patients with identified causes of diarrhea other than E. histolytica.
* Use within 2 weeks of enrollment of any drug or therapy with possible anti-protozoal activity.
* Females who are pregnant, suspected of being pregnant or breastfeeding.
* Serious systemic disorders incompatible with the study.
* History of hypersensitivity to nitazoxanide.
* Patients in whom the possibility of receiving placebo and not being able to receive immediately an effective treatment will be incompatible with the severity of the patient's illness.
* Patients with amebic liver abscess.
* Patients known to have or suspected of having AIDS.
* Patient with immune deficiencies.

Primary outcomes:
measure: Resolution of clinical symptoms of amebiasis
Secondary outcomes:
measure: Eradication of cyst or trophozoites of E. histolytica from post-treatment stool samples
measure: Time from initiation of treatment to passage of last unformed stool
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: University Hospital
city: Benha
country: Egypt
facility: Benha University Hospital
Study officials:
affiliation: Benha University
name: Samir M Kabil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Yehia El-Gohary, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06396936: The Effect of Calisthenic Exercises
Official title: Investigation of the Effects of Physical Activity on Smartphone Addiction, Pain and Sleep Quality in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Sleep Hygiene
Smartphone Addiction
Pain
Keywords: Physical Inactivity
Sleep Hygiene
Smartphone Addiction
Pain
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will investigate the effects of physical activity in young adults. With the increase in physical activity, the change in smartphone addiction, pain and sleep quality parameters will be evaluated.

Detailed description: This study aims to increase physical activity with a calisthenic exercise program. An answer will be sought to the question of whether increased physical activity causes changes in phone addiction, pain and sleep quality parameters.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study.
* Being between the ages of 15-35.

Exclusion Criteria:

* Individuals with an orthopedic and/or neurological disease that will affect their sleep health and/or pain level,
* Individuals with physical disabilities,
* Individuals who have undergone any surgical procedure in the last 6 months.

Primary outcomes:
measure: Sleep Quality
timeFrame: The evaluation will be applied at the beginning of the treatment program.
measure: Smartphone addiction
timeFrame: The evaluation will be applied at the beginning of the treatment program.
measure: Physical Activity
timeFrame: The evaluation will be applied at the beginning of the treatment program.
measure: Levels of Quality of life
timeFrame: The evaluation will be applied at the beginning of the treatment program.
Secondary outcomes:
measure: Pain intensity (neck pain and head pain)
timeFrame: The evaluation will be applied at the beginning of the treatment program
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
Study officials:
affiliation: KTO Karatay University
name: Osman Karaca, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02950636: Effect of Yoga on Mood and Quality of Life in Patients With Refractory Epilepsy
Official title: Effect of Yoga on Mood and Quality of Life in Patients With Refractory Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Keywords: Epilepsy
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2016-11-01
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to learn if a structured yoga program can reduce anxiety, improve depression, and improve quality of life in patients with medication resistant epilepsy (MRE).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of unilateral or bilateral temporal lobe epilepsy
* Presence 3 or more seizures per month
* No medical contraindications to yoga
* Willing and able to perform simple non strenuous yoga exercises
* Ability to get on the floor and up again without assistance
* Ambulatory
* Ability to travel to the yoga class twice a week

Exclusion Criteria:

* Any yoga in the last 6 months
* Inability to perform yoga exercises
* History of epilepsy surgery within the last year
* Currently pregnant or less than 6 week postpartum

Primary outcomes:
measure: Change in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)
timeFrame: Change from Week 4 to Week 12
Secondary outcomes:
measure: Change in Generalized Anxiety Disorder 7-item (GAD-7) scale
timeFrame: Change from Week 4 to Week 12
measure: Change in Quality of Life in Epilepsy-Patient-Weighted (QOLIE-31-p)
timeFrame: Change from Baseline to Week 12
measure: Frequency of seizures
timeFrame: Week 12
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Nancy Hammond, MD
role: PRINCIPAL_INVESTIGATOR
References: