louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01777035: Early Mobilization in the ICU
Official title: Early Mobilization in the ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Keywords: mechanical ventilation
physical therapy
occupational therapy
ICU acquired weakness
critical illness myopathy
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 200
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: To study all ICU patients with an independent baseline functional status , who experience a critical illness requiring intubation and mechanical ventilation evaluating long-term cognitive and executive function and long term cost effectiveness in survivors who required mechanical ventilation.

Detailed description: Immediate mobilization of mechanically ventilated (MV) ICU patients is not part of usual care in the U.S. or internationally. Our previous work supports that early mobilization through physical and occupational therapy for ICU patients on the ventilator can help them experience less delirium, spend less time in the ICU and hospital, and become more independent when they leave. To advance our knowledge in this area, large longitudinal studies are needed to understand the long-term physical, cognitive and mental health status of survivors and to test how specific ICU therapies may affect these outcomes.

Eligibility criteria: Inclusion Criteria:

* Intubated and MV \> 24, \< 96 hours
* Baseline Barthel Index Functional Score \> 70, functional at home

Exclusion Criteria:

* Rapidly changing neurological conditions (e.g. stroke)
* Cardiac arrest as cause for respiratory failure
* Elevated intracranial pressure
* Pregnancy (due to inability to provide continuous fetal monitoring)
* Terminal condition (life expectancy \< 6 months)
* Traumatic brain injury, multiple limb fractures, pelvic fractures,
* Severe chronic pain syndrome on admission

Primary outcomes:
measure: presence of cognitive impairment
timeFrame: within the first 30 days after ICU admission
measure: presence of cognitive impairment
timeFrame: up to 1 year post discharge
Secondary outcomes:
measure: cognitive test score
timeFrame: up to 1 year post discharge
measure: institution free days
timeFrame: up to 1 yr post discharge
measure: Insulin Resistance
timeFrame: day 3 of mechanical ventilation
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: John P Kress, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolfe KS, Patel BK, MacKenzie EL, Giovanni SP, Pohlman AS, Churpek MM, Hall JB, Kress JP. Impact of Vasoactive Medications on ICU-Acquired Weakness in Mechanically Ventilated Patients. Chest. 2018 Oct;154(4):781-787. doi: 10.1016/j.chest.2018.07.016. Epub 2018 Sep 11.
Clinical trial NCT00467935: Scotoma Reduction in AMD Patients Treated With Ranibizumab
Official title: A Phase I/II Study to Evaluate Scotoma Reduction in And Limited Visual Acuity in aGe Related Macular Degeneration Patients Treated With Intravitreal Lucentis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Macular Degeneration
Keywords: amd
disciform
fibrosis
Lucentis
scotoma
Lead sponsor: Retina Research Foundation
Sponsor class: OTHER
First posted: 2007-05-01
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a trial aimed at patients with advanced wet macular degeneration and macular scarring treated wiht intravitreal injections of Lucentis.

Detailed description: Patients with severe wet macular degeneration and scarring in the center of the retina may benefit from treatment if the size of the blind spot is reduced wiht injections of Lucentis.

Eligibility criteria: Inclusion Criteria:

* BCVA \< 20/320
* Disciform macular degeneration wiht exudation

Exclusion Criteria:

* Non-amd CNV

Primary outcomes:
measure: scotoma reduction
timeFrame: 12 months
Secondary outcomes:
measure: improved visual function
timeFrame: 12 months
Other outcomes:
Locations:
city: Slingerlands
country: United States
facility: Retina Research Center
state: New York
Study officials:
affiliation: Retina Research Foundation
name: Paul M Beer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01849835: A Test of the Comparison Between Trans-rectal and Trans-perineal Biopsy of Prostate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complication
Keywords: rate of positive detection
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2013-05-09
Enrollment: 120
Sex: MALE
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this randomized controlled trial (RCT) is to compare the two ways (tras-rectal and trans-perineal) to perform prostate biopsy from the rate of Positive detection, complications, pain level, operation time and costs et al.


Eligibility criteria: Inclusion Criteria:

* prostate-specific antigen \> 4ng/ml
* Palpation is positive

Exclusion Criteria:

* older than 80y
* prostate-specific antigen \> 100 ng/ml

Primary outcomes:
measure: the rate of positive detections
timeFrame: 1year
Secondary outcomes:
measure: the incidence rate of each complication
timeFrame: 1 year
Other outcomes:
measure: pain level assessed by visual analogue scale
timeFrame: 1 year
Locations:
city: Shanghai
country: China
facility: 10Th Hospital of Tongji University
state: Shanghai
Study officials:
References:
citation: Evidence-based Guidelines for Best Practice in Health Care Transrectal Ultrasound Guided Biopsy of the Prostate
Clinical trial NCT04752735: Endovascular treatmenT for Acute Ischemic Stroke in China
Official title: Endovascular treatmenT for Acute Ischemic Stroke in China: a Retrospective, National, Multi-center, Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Endovascular Treatment
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients must receive endovascular treatment regardless of the time from onset to treatment.

Brief summary: This is a retrospective real world registry study, aiming to explore the effectiveness and safety of endovascular treatment of acute ischemic stroke in a Chinese population.


Eligibility criteria: Inclusion Criteria:

* Age: ≥ 18;
* Ischemic stroke confirmed by head CT or MRI;
* Patients receiving endovascular treatment;
* First ever stroke or mRS≤2 after previous disease;
* Complete and clear pre- and post-operative DSA images are available

Exclusion Criteria:

* Imaging data not qualified for evaluation;
* Absence of important clinical data;
* The first 50 patients receiving endovascular treatment in a single centerr.

Primary outcomes:
measure: Proportion of patients with modified Rankin Score (mRS) 0 to 2
timeFrame: Day 90
Secondary outcomes:
measure: Changes in National Institute of Health stroke scale (NIHSS)
timeFrame: Day 2, 7, 14
measure: Proportion of patients with modified Rankin Score 0 to 2
timeFrame: Day180, 360
measure: Distribution of modified Rankin Score
timeFrame: Day 90, 180, 360
measure: Proportion of symptomatic intracranial hemorrhage (sICH)
timeFrame: 48 hours
measure: Proportion of intraparenchymal hemorrhage (PH1 and PH2)
timeFrame: 48 hours
measure: Proportion of death
timeFrame: Day 7
measure: Changes in cerebral edema
timeFrame: 48 hours, 7 days
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Department of Neurology, General Hospital of Northern Theater Command
Study officials:
References:
Clinical trial NCT05813535: 8.4% Sodium Bicarbonate Locks in Intestinal Failure
Official title: Sodium Bicarb Locks in Intestinal Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Intestinal Failure
CRBSI - Catheter Related Bloodstream Infection
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 15
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: We plan to include children with intestinal failure, a condition where the gut is not functioning properly, leading these children to need central venous catheters (line that goes through the skin into the blood stream) for nutritional support and hydration. Such patients have a very high risk for catheter infection. The study will include placing an agent (sodium bicarbonate) into the central catheter when the catheter is not in use. This is referred to as a lock. The lock would be used daily and removed when patients start their nutritional support and hydration through the catheter.

Detailed description: Children with intestinal failure who rely on a silicone based central venous catheter for parenteral nutrition to provide nutritional support and hydration will be invited to participate in this study. The intervention will offer use of a specific catheter lock solution (8.4% sodium bicarbonate) when the catheter is not in use. This includes daily lock use with removal of the lock at end of dwell time.

Eligibility criteria: Inclusion Criteria:

* Subject fulfills diagnosis of intestinal failure with a central venous catheter in place used daily on outpatient basis for intravenous nutrition and /or intravenous hydration
* Subject is less than 18 years of age at the time of study entry
* Subject with history of at least 1 documented catheter related blood stream infection (verified by blood culture)

Primary outcomes:
measure: Rate of catheter related bloodstream infections
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
References:
Clinical trial NCT01015235: Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative Pain
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 for the Treatment of Postoperative Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain, Postoperative
Keywords: Ketorolac / therapeutic use
Analgesics. Non-narcotic / therapeutic use
Arthroplasty, replacement hip
Arthroplasty, replacement knee
Pain measurement / drug effect
Pain postoperative / drug therapy
Lead sponsor: KAI Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Trident Clinical Research Pty Ltd
First posted: 2009-11-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 determine whether KAI-1678 is effective in the treatment of postoperative pain following total hip or total knee replacement.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist (ASA) classification 1, 2, or 3
* total hip or total knee replacement
* pain on postoperative Day 1 at least 40 mm on 0-100 mm visual analog scale (VAS)

Exclusion Criteria:

* presence of contraindications to nonsteroidal anti-inflammatory (NSAID) treatment
* recent history of angina or myocardial infarction (MI)
* clinically significant abnormality on laboratory tests or electrocardiogram (ECG)

Primary outcomes:
measure: The effect of KAI-1678 on summed pain intensity difference over 4 hours (SPID 4).
timeFrame: Post operative Day 1
Secondary outcomes:
measure: The effect of KAI-1678 on total pain relief over 4 hours (TOTPAR 4)
timeFrame: Post operative Day 1
measure: The effect of KAI-1678 on pain intensity difference (PID) at 4 hours
timeFrame: Post-operative Day 1
measure: The effect of KAI-1678 on total quality analgesia
timeFrame: Post-operative Day 1
measure: The effect of KAI-1678 on time to meaningful pain relief
timeFrame: Post-operative Day 1
Other outcomes:
Locations:
city: Hamilton
country: New Zealand
Study officials:
affiliation: KAI Pharmaceuticals
name: Gregory Bell, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03577535: Evaluation of ONCOXIN® in Oral Mucositis, Appetite and Body Mass in Cancer Patients.
Official title: Evaluation of ONCOXIN® in Oral Mucositis, Appetite and Body Mass in Cancer Patients. Real World Setting Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mucositis Oral
Keywords: Oral Mucositis
Nutritional supplement
Chemotherapy
Radiotherapy
Ocoxin / Oncoxin
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2018-07-05
Enrollment: 15
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Oral mucositis is one of the most spread side effects of anticancer therapy. It is associated with both chemo- and radiotherapy, decreases QoL, relative dose intensity and leads to nutritive deficiency. Oral mucositis causes secondary infections, increased hospital stay, whereas pain syndrome results in an emotional distress, anorexia and disables natural feeding.

Detailed description: Primary:

To evaluate the efficacy of ONCOXIN on oral mucositis symptoms in patients who receive chemotherapy and/or radiotherapy.

Secondary:

To evaluate the effects of ONCOXIN on nutritional status in patients who receive chemotherapy and/or radiotherapy.

Eligibility criteria: Inclusion Criteria:

1. A signed and dated informed consent form;
2. Patients of both genders, aged 45-75;
3. Malignant neoplasms which have radio-, chemotherapy or their combinations prescribed;
4. ECOG ≤3;
5. WHO oral toxicity scale grade 2 - 3.

Exclusion Criteria:

1. Significant, according to the investigator judgement, concomitant diseases or states which make it complicate or even impossible the patient's participation in the study or make it difficult to interpret the clinical data obtained in any stage of the study always including the following:

   * Mental disorders;
   * Serious/chronic infectious and parasitic diseases;
   * Intolerability to any of ONCOXIN components.
2. Relations with study center personnel (study center staff or family member of the investigator, coordinator or assistant).
3. If the patient fails to assess his/her physical and emotional condition;
4. If the patient fails to comply with the requirements;
5. Patient's refusal to participate in the study;
6. Pregnancy or lactation.

Primary outcomes:
measure: Oral mucositis grade in patients during chemotherapy and radiotherapy treatments
timeFrame: 21 days
Secondary outcomes:
measure: Nutritional status of the patients during Chemotherapy and radiotherapy treatments related with weight gain
timeFrame: 21 days
measure: Nutritional status of the patients during Chemotherapy and radiotherapy treatments
timeFrame: 21 days
measure: Nutritional status of the patients during Chemotherapy and radiotherapy treatments
timeFrame: 21 days
Other outcomes:
Locations:
city: Samara
country: Russian Federation
facility: Medical Scientific centre of professor Shumsky
state: Samara Oblast
Study officials:
References:
Clinical trial NCT05228535: Human Milk in Preterm Infants
Official title: Early Fortification of Human Milk for Very Low Birth Weight Infants and Effects on Growth Velocity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Birth
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 50
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups. 1 group will be controlled, following standard NICU feeding protocol. 1 group will be intervention, receiving early introduction of human milk fortifier to enteral feeds.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Current NICU protocol introduces human milk fortifier at 8 days of feeding. This study will introduce human milk fortifier at day 1. The primary outcome is the effect on growth velocity at 28 days and 36 weeks post menstrual age.


Eligibility criteria: Inclusion Criteria:

* Birth weight 1000-1500 grams
* Admitted to NICU within 24 hours of life
* Maternal intent to use human milk

Exclusion Criteria:

* Congenital anomalies
* Feeds not started within the first 96 hours of life
* Intrauterine growth restriction

Primary outcomes:
measure: Growth velocity
timeFrame: at 28 days of life
Secondary outcomes:
measure: Growth velocity
timeFrame: at 36 weeks post menstrual age
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Children's Hospital of Georgia
state: Georgia
Study officials:
References:
Clinical trial NCT05385835: Brachial Artery Blood Pressure Measurement Training
Official title: Comparison of Knowledge and Skills Levels of Nurses Who Take Training on Blood Pressure Measurement From The Brachial Artery, After and Before Training
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nurse Training
Keywords: education, nurse, blood pressure measurement
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Nurses working at Kaçkar State Hospital

Brief summary: The research is a pre-post-test observation study without a control group, aiming to determine the effect of the training given to nurses on the knowledge and practices of brachial artery blood pressure measurement.

Detailed description: The nurses who were informed about the study and agreed to participate in the study will be followed by two observers at the same time and filled in the "Blood Pressure Measurement Observation Form". Nurses will not be informed by whom and when they will be observed. Each observer will observe each nurse three times (1st observation). After the first observation is over, the "Blood Pressure Knowledge Test" will be applied to the nurses (Pre-test). Then, the training program prepared by the researcher will be uploaded to the hospital automation system and nurses will be asked to follow it. In addition, nurses will be able to log in to the training module and watch the video again and again whenever they want. Nurses will be given a two-week period to follow the training module. At the end of two weeks, the nurses will fill out the "Blood Pressure Information Test" again (2nd test). The "Blood Pressure Measurement Observation Form" will be filled in by the researcher during the blood pressure measurement of the nurses again in the form of the final follow-up (2nd observation).

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study
* Measurement of blood pressure from the brachial artery with a sphygmomanometer
* Caring for adult patients

Exclusion Criteria:

* Using only digital sphygmomanometer in the clinic
* Caring for pediatric patients

Primary outcomes:
measure: 1. The effect of the training given to nurses on the level of knowledge of blood pressure measurement from the brachial artery
timeFrame: About 45 days until 10 June 2022
Secondary outcomes:
measure: 2. The effect of training given to nurses on brachial artery blood pressure measurement practices
timeFrame: About 45 days until 10 June 2022
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Teknik Üniversitesi
Study officials:
affiliation: KARADENİZ TEKNİK ÜNİVERSİTESİ
name: Burçin Gönenç
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00981435: Steroids After Laser Trabeculoplasty for Glaucoma
Official title: Steroids And Laser Trabeculoplasty (SALT) Trial: Effect of Anti-Inflammatory Treatment on the Efficacy of SLT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: Glaucoma
Trabeculoplasty
Selective laser trabeculoplasty
Intraocular pressure
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Bascom Palmer Eye Institute
name: University of Pittsburgh Medical Center
First posted: 2009-09-22
Enrollment: 97
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 determine whether the choice of post-operative eye drop administered after selective laser trabeculoplasty (SLT) for glaucoma affects the efficacy in lowering intraocular pressure (IOP).

Detailed description: SLT is used to lower intraocular pressure in glaucoma, but it is not know whether the choice of eyedrops administered in the post-operative period affects SLT efficacy. Practitioners commonly use steroid drops, non-steroidal anti-inflammatory drops, or no drops at all. This is a randomized, single-center, prospective, masked clinical trial to determine whether the choice of eyedrop affects efficacy of SLT in glaucoma patients.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of glaucoma
* clinician has determined that SLT laser is indicated
* IOP currently \>18 and was ever \>21 in the past (e.g. prior to treatment)

Exclusion Criteria:

* prior history of uveitis
* prior glaucoma surgery including glaucoma laser surgery
* pregnant or 3 months post-partum

Primary outcomes:
measure: Intraocular Pressure (IOP) Change
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Intraocular Inflammation
timeFrame: Up to week 12
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Stanford University
name: Jeffrey L Goldberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: