louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01792739: Lactobacillus Preparation on the Incidence of Diarrhea
Official title: The Impact of Lactobacillus Preparation on the Incidence of Diarrhea in Intensive Care Unit-admitted Patients : Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diarrhea
Death
Pneumonia
Keywords: Probiotics
Diarrhea
Intentive care units
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 124
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this trial is to clarify the impact of lactobacillus preparation on the incidence of diarrhea in ICU-admitted patients.

Almost all patients in ICU are treated with antibiotics for the effective control of various infections. However, antibiotics-associated diarrhea is another matter of concern. Many previous studies were proved that the use of probiotic lactobacillus preparation can reduce antibiotics-associated diarrhea in ward-admitted patients. In this study, we are planning to perform a similar study in severely ill patients in ICU.


Eligibility criteria: Inclusion Criteria:

* All patients admitted in intensive care unit
* Age more than 19

Exclusion Criteria:

* Diarrhea occurence within 1 week of ICU admission
* Recent history of probiotics use (within 1 month)
* GI obstruction
* History of abnormal symptoms and sign for the probiotics use (rash, edema, sepsis, etc.)
* immunocompromized patients

Primary outcomes:
measure: Diarrhea-free days
timeFrame: Duration from the first-administration day of probiotics till the first onset day of diarrhea during ICU residence (up to 8 weeks)
Secondary outcomes:
measure: 28day-mortality
timeFrame: 28 day
measure: Positive results of C.difficile toxin
timeFrame: The first onset of diarrhea during ICU residence (up to 8 weeks)
measure: ICU-acquired pneumonia
timeFrame: The first day of occurence of ICU-acquired pneumonia (up to 8 weeks)
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Bundang-Gu
city: Goyang
country: Korea, Republic of
facility: Myongji Hospital
state: Deokyang-gu
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
state: Dongjak-gu
Study officials:
affiliation: Seoul National University College of Medicine
name: Chang Hoon Lee, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hickson M, D'Souza AL, Muthu N, Rogers TR, Want S, Rajkumar C, Bulpitt CJ. Use of probiotic Lactobacillus preparation to prevent diarrhoea associated with antibiotics: randomised double blind placebo controlled trial. BMJ. 2007 Jul 14;335(7610):80. doi: 10.1136/bmj.39231.599815.55. Epub 2007 Jun 29.
Clinical trial NCT02107586: Comparison of Outcomes Between Biceps Tenotomy and Tenodesis in the Treatment of the Long Head of the Biceps Pathology
Official title: Biceps Tenotomy or Tenodesis in Treating Long Head of the Biceps Pathology: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Refractive Bicipital Pain
Keywords: biceps tenodesis
biceps tenotomy
biceps tendonitis
biceps inflammation
shoulder surgery
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 6
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 the study is to determine what the different outcomes are for biceps tenodesis and tenotomy in the treatment of the long head of the biceps pathology.


Eligibility criteria: Inclusion Criteria:

* patient with chronic refractive bicipital pain

Exclusion Criteria:

-

Primary outcomes:
measure: American Shoulder and Elbow Surgeons (ASES) Shoulder Score
timeFrame: one year
Secondary outcomes:
measure: EuroQol EQ-5D
timeFrame: one year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Lewis L Shi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03307239: Cold Application on Pain During Chest Tube Removal
Official title: Efficacy of Cold Application on Pain During Chest Tube Removal: A Randomized Controlled Trial : A CONSORT Compliant Article
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Tube Removal
Lead sponsor: Chiayi Christian Hospital
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: subjects in the experimental group received cold application of 600 g ice packs 15 min before CTR, whereas subjects in the sham group
Primary purpose: TREATMENT

Brief summary: Abstract Objectives: Use of analgesics is the most common method to alleviate the pain induced by chest tube removal (CTR), but patient response to medication can vary and may not be achieved complete relaxation. This study was to determine the effectiveness of cold application in combination with standard analgesic administration before CTR on CTR-induced pain.

Methods: A prospective, randomized, single-blind, placebo sham-controlled study was conducted. In addition to the same routine care, subjects in the experimental group (n = 30) received cold application of 600 g ice packs 15 minutes before CTR, whereas subjects in the placebo sham group (n = 30) received tap water packs. Numerical rating scale was used to measured pain intensity before, immediately after, and 10 minutes after CTR.


Eligibility criteria: Inclusion Criteria:

* (a) age greater than 20 years, (b) single chest-tube insertion, (c) first-time insertion of the chest tube, (d) ability to verbally report pain, (e) body mass index of \< 30 kg/m2, and (f) normal vital signs.

Exclusion Criteria:

* cold urticaria

Primary outcomes:
measure: numerical rating scale (NRS)
timeFrame: before cold application
measure: numerical rating scale (NRS)
timeFrame: immediately after chest tube removal
measure: numerical rating scale (NRS)
timeFrame: 10 minutes after chest tube removal
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hsieh LY, Chen YR, Lu MC. Efficacy of cold application on pain during chest tube removal: a randomized controlled trial: A CONSORT-compliant article. Medicine (Baltimore). 2017 Nov;96(46):e8642. doi: 10.1097/MD.0000000000008642.
Clinical trial NCT01284439: Hydroxypropylmethylcellulose 0.3% and Sodium Hyaluronate 0.18% for Ocular Surface Disease in Glaucoma
Official title: Effect of Hydroxypropylmethylcellulose 0.3% and Sodium Hyaluronate 0.18% in the Treatment of Ocular Surface Disease in Glaucoma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ocular Surface Disease
Glaucoma
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-01-27
Enrollment: 120
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: To study effect of hydroxypropylmethylcellulose 0.3% and sodium hyaluronate 0.18% in the treatment of ocular surface disease in glaucoma patients.


Eligibility criteria: Inclusion Criteria:

* OSDI \> or equal 20 and eye lid inflammation , meibomian gland inflammation,conjunctival injection,follicle at tarsus , positive corneal staining , tear break up time less than 8 seconds , tear volume less than 5.5 mm.

Exclusion Criteria:

* Age below 18 yo
* Active infectious corneal disease
* Post penetrating keratoplasty or glaucoma drainage device
* Known allergy to medication
* Lactation , Pregnant

Primary outcomes:
measure: Ocular surface index score
timeFrame: 1 month
Secondary outcomes:
measure: Eye lid inflammation, corneal staining score, tear break up time and tear volume
timeFrame: 1 month
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Ophthalmology , Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: AssocProf Pinnita Tanthuvanit, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01610739: Carpal Tunnel Release Effects on Median Nerve Perfusion
Official title: Effect of Carpal Tunnel Release on Median Nerve Perfusion Using SPY Scope Imaging
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2012-06-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to examine the effect of carpal tunnel release on blood flow to the median nerve using SPY scope imaging to view the perfusion to the nerve.

Detailed description: The study will involve patients undergoing carpal tunnel release surgery at our institution, with no change in the actual procedure performed. Using the SPY Scope, we will measure blood flow prior to the carpal tunnel release, and again measure once carpal tunnel release has been performed, in order to compare the values. This may add roughly 15 minutes to the total procedure time, however, no steps in the actual operation will be altered or affected in any way.

Eligibility criteria: Inclusion Criteria:

* carpal tunnel syndrome
* 18 years or older

Exclusion Criteria:

* pregnant
* less than 18 years of age
* allergy to iodide or iodinated contrast agents

Primary outcomes:
measure: Effect of median nerve perfusion with carpal tunnel release
timeFrame: intraoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Nadia M Obeid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03851939: The Efficacy of Transarterial Chemoinfusion (TAI) Combine Toripalimab in Advanced Hepatocellular Carcinoma (HCC)
Official title: The Efficacy of Transarterial Chemoinfusion (TAI) Combine Toripalimab in Advanced Hepatocellular Carcinoma (HCC): A Prospective, Single-armed, Stage II Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 65
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: TREATMENT

Brief summary: To evaluate the efficacy of TAI combine toripalimab in advanced HCC.


Eligibility criteria: Inclusion Criteria:

* older than 18 years old and younger than 75 years;
* ECOG PS≤1;
* proven advanced hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
* not previous treated for tumor;
* cannot accepted hepatectomy;
* the lab test could meet:

  * neutrophil count≥2.0×109/L;
  * hemoglobin≥100g/L;
  * platelet count≥75×109/L;
  * serum albumin≥35g/L;
  * total bilirubin\<2-times upper limit of normal;
  * ALT\<3-times upper limit of normal;
  * AST\<3-times upper limit of normal;
  * serum creatine\<1.5-times upper limit of normal;
  * PT≤upper limit of normal plus 4 seconds;
  * INR≤2.2;
* sign up consent;

Exclusion Criteria:

* cannot tolerate TAI or toripalimab;
* known history of other malignancy;
* be allergic to related drugs;
* underwent organ transplantation before;
* be treated before (interferon included);
* known history of HIV infection;
* known history of drug or alcohol abuse;
* have GI hemorrhage or cardiac/brain vascular events within 30 days;
* pregnancy;

Primary outcomes:
measure: PFS
timeFrame: From date of randomization until the date of progression, assessed up to 36 months
measure: ORR
timeFrame: From date of randomization until the date of death, assessed up to 36 months
Secondary outcomes:
measure: OS
timeFrame: From date of randomization until the date of death from any cause, assessed up to 36 months
measure: DCR
timeFrame: From date of randomization until the date of death, assessed up to 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: SUN YAT-SEN University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT00535639: Tolerability of ALK Tree Tablet
Official title: A Randomised, Multiple Dose, Dose Escalation, Double-Blind, Placebo-Controlled Phase I Study Investigating the Safety of ALK Tree Tablet in Adult Subjects With Birch Pollen Induced Rhinoconjunctivitis (With/Without Asthma).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergy
Keywords: Tolerability of ALK Tree Tablet in patients with birch pollen induced allergy
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2007-09-26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This trial is performed to assess the tolerability of the ALK Tree Tablet in patients with birch pollen induced allergy


Eligibility criteria: Inclusion Criteria:

* A clinical history of birch pollen induced rhinoconjunctivitis (with or without mild to moderate asthma ) of at least two years prior to trial entry requiring symptomatic treatment during the birch pollen season.
* Positive Skin Prick Test response to Betula verrucosa
* Positive specific IgE against Bet v1
* FEV1 ≥ 70% of predicted value

Exclusion Criteria:

* No clinical history of perennial allergic rhinitis and/or asthma caused by an allergen to which the subject is regularly exposed and sensitised
* No clinical history of significant recurrent acute sinusitis (defined as 2 episodes per year for the last two years all of which required antibiotic treatment) or chronic sinusitis
* No conjunctivitis, rhinitis or asthma at the screening or randomisation visit
* No history of anaphylaxis, including anaphylactic food allergy, bee venom anaphylaxis, exercise anaphylaxis or drug induced anaphylaxis
* No history of angioedema

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: PhaseOne Trials
Study officials:
affiliation: PhaseOne Trials
name: Kim Krogsgaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03530839: Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty
Official title: Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Claw Toe
Lesser Toe Deformity
Keywords: lesser toe deformity
claw toe
PIP joint
arthrodesis
resection arthroplasty
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 37
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: The aim of this study was to compare operative outcomes after lesser toe deformity correction with either proximal interphalangeal (PIP) joint arthrodesis or PIP joint resection arthroplasty.

Methods: A prospective randomized controlled trial was performed on 37 patients (48 toes) who underwent one of these two procedures. The Numeric Rating Scale (NRS) for pain, American Orthopaedic Foot and Ankle Society (AOFAS) score, osseous consolidation, and clinical outcome were evaluated preoperatively and at 6 weeks and 6 months postoperatively.


Eligibility criteria: Inclusion Criteria:

* Patients with one or more claw toes with rigid PIP joint flexion and extension deformity of the MTP joint scheduled for surgical intervention in the investigator's department

Exclusion Criteria:

* known osteoporosis or other bone metabolism disorders
* prior surgery on the toe scheduled for the intervention
* immunodeficiency or immunosuppressive drug intake
* pregnancy
* non-palpable pulses of the posterior tibial artery or the dorsalis pedis artery
* anticoagulation therapy with the exception of acetylsalicylic acid
* a lack of sufficient physical resilience to allow free self-mobilization and walking.

Primary outcomes:
measure: Pain
timeFrame: Change from preoperatively to 6 weeks postoperatively and to 6months postoperatively
measure: Function
timeFrame: Change from preoperatively to 6 weeks postoperatively and to 6months postoperatively
Secondary outcomes:
measure: Osseous consolidation
timeFrame: 6months postoperatively
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01752439: Effects of Transcranial Direct Current Stimulation in Refractory Chronic Migraine and Medication-overuse Headache
Official title: Randomized Double-Blind Sham-Controlled Study of the Effects of Transcranial Direct Current Stimulation in Refractory Chronic Migraine and Medication-overuse Headache Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Migraine
Medication Overuse Headache
Keywords: Chronic Migraine
Medication Overuse Headache
Refractory
transcranial direct current stimulation
Lead sponsor: Mediterranean Neurological Institute
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy of the transcranial direct current stimulation of the primary motor cortex (M1) in patients affected by refractory chronic migraine (coded as 1.5.1 in the international headache classification 2nd edition, 2004) and medication-overuse headache (coded as 8.1) with migraine as primary headache.


Eligibility criteria: Inclusion Criteria:

* Chronic MIgraine or Medication Overuse Headache according to the diagnostic criteria set out in the 2nd edition of the International Classification of Headache Disorders refractory to treatment according to the Refractory Headache Special Interest Section of the American Headache Society (Schulman et al., 2008)

Exclusion Criteria:

* Other primary or secondary headaches.
* Any serious systemic or neurological disease or psychiatric disorder.
* Pregnancy or breastfeeding
* Previous or current use of other or similar devices for pain control
* Heart conduction and rhythm disorders
* Cranial surgery
* Other pain conditions, accordingly with current guidelines

Primary outcomes:
measure: Change in headache days per months
timeFrame: at 30, 60 and 90 days after the treatment
measure: Change in drugs intake per months
timeFrame: at 30, 60 and 90 days after treatment
Secondary outcomes:
measure: Change in mean pain intensity score per months
timeFrame: at 30, 60 and 90 days after treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02847039: Early Repolarization Syndrome: Define the Risk, Stratify the Coverage and Understand the Causes - Clinical and Genetic Study
Official title: Early Repolarization Syndrome: Define the Risk, Stratify the Coverage and Understand the Causes - Clinical and Genetic Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Repolarization Syndrome
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 200
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with an aspect of early repolarization syndrome or belonging to a family in which the diagnosis of early repolarization was identified.

Brief summary: The research project aims to try to answer the many questions raised by the identification of new early repolarization syndrome. The questions are varied with both taking optimal clinical management of patients, the frequency and significance of this anomaly in the population on the electrophysiological and molecular basis responsible for this electrocardiographic abnormality.

To try to answer these many questions, the approach will be twofold: clinical and genetic.

* Establishment of a clinical database containing information of patients who have been identified as carriers of the anomaly based on the initial clinical presentation in order to determine their prognoses.
* Physiological approach will be based on a molecular approach to identify genetic abnormalities may be involved in this syndrome.
* 200 asymptomatic patients and an unlimited number of patients who presented syncope or aborted sudden death will be included.

A blood sample (15 ml) will be performed at inclusion.


Eligibility criteria: Inclusion Criteria:

* Presence of early repolarization aspect, determined by the J point elevation of at least 0.1 mV above the isoelectric line, with or without extra-ST segment elevation in at least two leads and / or lateral.
* Parameters ECG D2 level of the bypass measurable for the presence of long QT syndrome.
* Late potentials ventricular analyzable.
* For patients with ventricular fibrillation, negative search for other causes of ventricular fibrillation.
* For patients with syncope, clinical assessment should included at a minimum, performing a cardiac ultrasound and a stress test.

Exclusion Criteria:

* Impossibility to receive clear information (patient's intellectual default).
* Refusal to sign the informed consent for participation.
* Under protective measure of justice.

Primary outcomes:
measure: Incidence of ventricular fibrillation or sudden death
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
References: