louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01868529: Comparison of Insulin Degludec With Insulin Glargine in Subjects With Type 1 Diabetes Mellitus
Official title: A Randomised, Single Centre, Double-blind, Two-Period Cross-over, Multiple Dose Trial Comparing the Pharmacodynamic Response of Insulin 454 With Insulin Glargine at Steady-State Conditions in Subjects With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-06-04
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial was conducted in Europe. The aim of this trial was to compare the pharmacodynamic (the effect of the investigated drug on the body) response of insulin degludec (insulin 454) with insulin glargine at steady-state conditions in subjects with type 1 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) and treated with insulin for at least 12 months
* Subject is considered to be generally healthy, except for the underlying diabetes mellitus and related morbidity (such as well controlled hypertension and dyslipidaemia) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
* Body Mass Index (BMI) between 18.0 and 28.0 kg/m\^2 (both inclusive)
* Glycosylated haemoglobin (HbA1c) below or equal to 10.0 % based on central laboratory results
* Subject with a daily basal insulin requirement of between 0.2 IU/kg/day and 0.6 IU/kg/day will be allowed to participate in the trial. Current total daily treatment with insulin must be less than 1.2 U/kg/day

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products
* Subject who has participated in any other trials involving investigational products within 3 months preceding the start of dosing
* Subject who has donated any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening

Primary outcomes:
measure: Area under the glucose infusion rate curve
timeFrame: 0-24 hours in steady-state
Secondary outcomes:
measure: Area under the serum insulin concentration curve at steady state
timeFrame: 0-24 hours after dosing
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06557629: Reaching a Caloric Goal Using a Gastric Sonar Versus Aspiration of Gastric Contents in Critically Ill Patients Receiving Nasogastric Enteral Nutrition
Official title: Reaching a Caloric Goal Using a Gastric Sonar Versus Aspiration of Gastric Contents in Critically Ill Patients Receiving Nasogastric Enteral Nutrition - Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Enteral Nutrition Intolerance in Critically Ill Patients
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Enteral nutrition intolerance, manifested in delayed gastric emptying and high gastric residual, is a common problem in critically ill patients in intensive care, with adverse consequences on patients' outcomes. A decrease in the levels of the ghrelin hormone in these patients may contribute to this problem. The gastric residual test (GRV) is used to assess enteral absorption and gastric motility, but the traditional methods can lead to inaccuracy and waste of resources. In recent years, the use of ultrasound (PoCUS) to assess GRV has developed, but its effect on the rate of reaching the caloric goal has not yet been evaluated.


Eligibility criteria: Inclusion Criteria: Adult intensive care patients who recieve enteral nutrition via nasogastric tube -

Exclusion Criteria: 1. Pregnant patient 2. History of bariatric or other gastric surgery 3. Post-operative patients with sub-costal incision 4. Diaphragmatic hernia 5. Patients who recieve parenteral nutrition 6. Technically difficult US exam

-

Primary outcomes:
measure: Reaching the daily caloric goal
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT01915329: Effects of Repetitive Electric Sensory Stimulation (RSS) as Intervention in Complex-regional-pain-syndrome Type I (CRPS)
Official title: Effects of Repetitive Electric Sensory Stimulation on Sensorimotor Performance and Pain Intensity in Complex Regional Pain Syndrome Type I
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complex Regional Pain Syndrome Type I of the Upper Limb
Keywords: CRPS
repetitive sensory stimulation
cortical reorganization
2-point-discrimination
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 50
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: BASIC_SCIENCE

Brief summary: The purpose of this study is to test a specific nerve stimulation protocol as therapeutic option in patients diagnosed with CRPS (complex regional pain syndrome) of the upper extremity.

Detailed description: A specific high frequency electric stimulation is conveyed at 5 days to the affected hand. Each stimulation session lasts 45 minutes.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with CRPS Type I

Exclusion Criteria:

* intolerable hyperalgesia
* lesions at the fingertips
* high grade digit contracture
* central neurologic disorders
* psychiatric disorders

Primary outcomes:
measure: static tactile 2-point-discrimination threshold
timeFrame: before and after the 5 day stimulation phase with a minimum time of 1h between measurements and start/end of the stimulation (day1 pre and day 5 post)
Secondary outcomes:
measure: pain intensity
timeFrame: before and after the 5 day stimulation phase with a minimum time of 1h between measurements and start/end of the stimulation (day1 pre and day 5 post)
Other outcomes:
measure: somatosensory evoked potentials
timeFrame: before and after the 5 day stimulation phase with a minimum time of 1h between measurements and start/end of the stimulation (day1 pre and day 5 post)
Locations:
city: Bochum
country: Germany
facility: Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH
state: NRW
Study officials:
References:
Clinical trial NCT06452329: A Study to Evaluate Nivolumab in Patients With Unresectable Advanced/Metastatic Gastric Cancer and Gastroesophageal Junction Cancer
Official title: Retrospective Evaluation of Nivolumab in First-Line Unresectable Advanced or Metastatic Gastric Cancer (GC) and Gastroesophageal Junction Cancer (GEJC): A Non-interventional Observational Study in China
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gastric Cancer
Gastroesophageal Junction Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-06-11
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with unresectable advanced or metastatic Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJC) treated with nivolumab as first-line treatment.

Brief summary: The purpose of this study is to collect and evaluate real-world data to enhance understanding of the effectiveness, and treatment patterns of first-line nivolumab treatment in patients with unresectable advanced or metastatic gastric cancer/gastroesophageal junction cancer (GC/GEJC) in China


Eligibility criteria: Inclusion Criteria:

* Participants aged ≥ 18 years at date of first administration of nivolumab
* Confirmed diagnosis of unresectable advanced or metastatic Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJC) (histologically or cytologically)
* Participants newly received nivolumab as first-line (1L) treatment between 15 June 2018 and 30 June 2023
* Participants with at least one tumor assessment after index date except for death or discontinuation due to Adverse Events

Exclusion Criteria:

* Participants with primary malignancies other than unresectable advanced or metastatic GC/GEJC
* Participants who participate in an interventional clinical trial in or before 1L nivolumab treatment for advanced/metastatic GC/GEJC
* Participants with known HER2 status positive
* Participants who investigator deems inappropriate for inclusion, for example clinical data was incomplete

Primary outcomes:
measure: Time to progression (TTP)
timeFrame: Up to 68 months
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 68 months
measure: Duration of response (DOR)
timeFrame: Up to 68 months
measure: Participant socio-demographics
timeFrame: Baseline
measure: Participant baseline clinical characteristics
timeFrame: Baseline
measure: Participant treatment patterns
timeFrame: Up to 68 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Local Institution - 0001
state: Hubei
city: Shanghai
country: China
facility: Tianjin Happy Life Technology Co., Ltd
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00753129: Head Elevation in Prone Position
Official title: Influence of Head Elevation in Prone Position on Gas Exchange and Lung Mechanics in Patients With ALI/ARDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gas Exchange
Lung Mechanics
Keywords: Prone position
ALI/ARDS
Head elevation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Semi-recumbent position leads to improvement of gas exchange and lung mechanics in patients suffering from ALI or ARDS. Prone positioning leads to similar effects. To date, no data on the combination of these two positioning measures exist. The investigators hypothesize that head elevation in prone position leads to improvement in gas exchange and lung mechanics.


Eligibility criteria: Inclusion Criteria:

* Mechanically ventilated
* ALI or ARDS
* No contraindications for prone position

Exclusion Criteria:

* Patient \< 18 or \> 89 years old
* Pregnancy
* Elevated intracranial pressure
* PaO2/FiO2 - ratio \< 60
* ECMO
* Open abdomen
* Instable spine
* Malignant arrhythmias
* Severe hemodynamic instability

Primary outcomes:
measure: PaO2/FiO2 ratio
timeFrame: Study period (5 hours on 2 consecutive days)
Secondary outcomes:
measure: PaCO2, Compliance (Chest wall, lung, respiratory system)
timeFrame: Study period (5 hours on 2 consecutive days)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Dept. of Internal Medicine I, Intensive Care Unit, Medical University of Vienna
Study officials:
References:
citation: Robak O, Schellongowski P, Bojic A, Laczika K, Locker GJ, Staudinger T. Short-term effects of combining upright and prone positions in patients with ARDS: a prospective randomized study. Crit Care. 2011;15(5):R230. doi: 10.1186/cc10471. Epub 2011 Sep 29.
Clinical trial NCT05633329: Dual Injection ESPB Versus Single Injection ESPB for Laparotomies
Official title: Comparison Between the Efficacy of Ultrasound Guided Single Injection Erector Spinae Plane Block Versus Dual Injection Erector Spinae Plane Block for Postoperative Pain in Patients Undergoing Abdominal Surgery: Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Regional Block
Keywords: ESPB
pain
regional block
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate and compare the efficacy of single level injection erector spinae plane block versus double level injection Erector spinae plane block in laparotomies


Eligibility criteria: Inclusion Criteria:

1. Age18-60.
2. Both genders.
3. abdominal surgery.
4. ASA I-III.

Exclusion Criteria:

1. Drug allergy.
2. Morbid obesity (BMI \>40 kg/m2).
3. Psychiatric disorder.
4. Opiod dependence.
5. patient refuse.

Primary outcomes:
measure: first analgesic request
timeFrame: 24 hours
Secondary outcomes:
measure: resting visual analogue pain scale
timeFrame: 24 hours
measure: dynamic visual analogue pain scale
timeFrame: 24 hours
measure: analgesic consumption
timeFrame: 24 hours
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
state: Minia
Study officials:
affiliation: Minia University, faculty of medicine
name: hassan m. hetta, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01802229: Prevention of Umbilical Port-site Hernia After Laparoscopic Cholecystectomy Using a Prosthetic Mesh Versus Simple Suture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Port-site Hernia
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The incidence of port-site hernia in patients with risk factors (obesity, elderly, diabetes and lung disorders) can be reduced by the use of a prophylactic mesh in the closure of umbilical port site.


Eligibility criteria: Inclusion Criteria:

* Age \> 65 years
* BMI \> 30 Kg/m2
* Diabetes mellitus
* Lung disease
* Elective laparoscopic cholecystectomy

Exclusion Criteria:

* Umbilical hernia
* Previous laparotomy
* Conversion to open procedure
* Loss during the follow up

Primary outcomes:
measure: Incidence of port-site hernia
timeFrame: 12 months
Secondary outcomes:
measure: Postoperative pain
timeFrame: 12 months
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital general Universitario de Elche
state: Alicante
Study officials:
References:
Clinical trial NCT00091429: Ranolazine SR in Patients With Chronic Angina Who Remain Symptomatic Despite Maximal Treatment With Amlodipine
Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of Ranolazine SR at a Dose of 1000 mg Twice a Day in Patients With Chronic Angina Who Remain Symptomatic Despite Treatment With Amlodipine 10 mg Once a Day
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Angina
Keywords: Angina
Chest Pain
Coronary Artery Disease
Heart Disease
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2004-09-10
Enrollment: 500
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 study will be a multi-national, double-blind, randomized, placebo-controlled, parallel group study to evaluate the effectiveness of ranolazine (1000 mg twice daily) in approximately 500 patients with chronic angina who remain symptomatic despite daily treatment with the maximum labeled dose of amlodipine (10 mg daily), a calcium channel blocker approved for the treatment of chronic angina. Eligible patients will be randomized to receive ranolazine 1000 mg or placebo twice daily, in addition to a daily dose of 10 mg of amlodipine. Participation in the study will last approximately 3 months.


Eligibility criteria: Eligible patients must have a diagnosis of chronic angina, with documented evidence of coronary artery disease or prior myocardial infarction, in addition to other study entry criteria. Prior to entering the study, patients will be required to have had at least two weeks of treatment with amlodipine 10 mg daily, with the discontinuation of all other anti-anginal therapy for the duration of the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Stone PH, Gratsiansky NA, Blokhin A, Huang IZ, Meng L; ERICA Investigators. Antianginal efficacy of ranolazine when added to treatment with amlodipine: the ERICA (Efficacy of Ranolazine in Chronic Angina) trial. J Am Coll Cardiol. 2006 Aug 1;48(3):566-75. doi: 10.1016/j.jacc.2006.05.044. Epub 2006 Jun 15.
citation: Kohn CG, Parker MW, Limone BL, Coleman CI. Impact of angina frequency on health utility values of patients with chronic stable angina. Health Qual Life Outcomes. 2014 Mar 14;12:39. doi: 10.1186/1477-7525-12-39.
Clinical trial NCT06705829: Comparative Evaluation of the Performance of Different Thromboplastin Reagents on Prothrombin Time and Factorial Assays in Situations of Isolated Extrinsic Pathway Factor Deficiency or Liver Damage.
Official title: Comparative Evaluation of the Performance of Different Thromboplastin Reagents on Prothrombin Time and Factorial Assays in Situations of Isolated Extrinsic Pathway Factor Deficiency or Liver Damage.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hemorrhagic Disorders
Extrinsic Pathway Factor Deficiency
Hepatocellular Insufficiency With Coagulopathy
Keywords: Thromboplastin sensitivity
Prothrombin time
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with an isolated (acquired or congenital) extrinsic pathway factor deficiency or with an hepatocellular insufficiency associated with a coagulopathy.

Brief summary: Primary purpose :

Compare the sensitivity of several thromboplastin reagents of various origins to prothrombin time and factor II, V, VII and X assays in two different populations of patients :

* Patients with an isolated extrinsic pathway deficiency (acquired or congenital) of factor II or V or VII or X.
* Patients with an hepatocellular insufficiency generally associated with coagulopathy (with an intensity proportional to the degree of hepatic impairment).

Results of this work should improve knowledge of sensitivity of the screening test represented by the prothrombin time, depending on the origin of thromboplastin reagent used, in relation with coagulopathies mentioned above, as well as the performance of factors II, V, VII, X assays. This work would help to choice of the most suitable reagent for the needs of each hemostasis laboratory/center.


Eligibility criteria: Inclusion criteria :

* Plasma samples from patients addressed to the laboratory of the Strasbourg University Hospital (Strasbourg France) collected and anonymized after completion of the routine testing.
* Patient with an isolated or combined extrinsic pathway factor deficiency (factor II, V, VII, X).

Exclusion criteria :

* Patient treated with an oral anticoagulant treatment.
* Patient treated with a parenteral anticoagulant treatment (apart from therapeutic dosages of unfractionated heparin and low molecular weight heparin).

Primary outcomes:
measure: Comparison of the sensitivity of several thromboplastin reagents on prothrombin time and factor II, V, VII and X assays
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg - Laboratoire de Virologie
Study officials:
References:
Clinical trial NCT02590029: Psychosocial Support for Acute Hospital Pain and Distress
Official title: Psychosocial Support for Acute Hospital Pain and Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 244
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 randomized study is to determine the impact of three different types of psychosocial support delivered by social workers to patients reporting uncontrolled pain during a hospital stay. This study will examine the differential effects of brief mindfulness training, therapeutic suggestion, and psychoeducation for patients reporting uncontrolled pain.


Eligibility criteria: Inclusion Criteria:

* English-speaking males or females 18 or older within the University of Utah Hospital system reporting "intolerable pain" or "inadequate pain control" on the Clinically Aligned Pain Assessment Tool (CAPA; Donaldson \& Chapman, 2013).

Exclusion Criteria:

* Altered mental status due to delirium, psychosis, or pharmacological sedation as determined by clinical assessment.

Primary outcomes:
measure: Pain intensity (numeric rating scale)
timeFrame: Immediately prior to and following intervention
measure: Pain unpleasantness (numeric rating scale)
timeFrame: Immediately prior to and following intervention
Secondary outcomes:
measure: Use of opioid analgesics
timeFrame: 24 hours prior to and following intervention
measure: Anxiety (numeric rating scale)
timeFrame: Immediately prior to and following intervention
measure: Relaxation (numeric rating scale)
timeFrame: Immediately prior to and following intervention
measure: Desire for opioids (numeric rating scale)
timeFrame: Immediately prior to and following intervention
measure: Positive body sensations (numeric rating scale)
timeFrame: Immediately prior to and following intervention
measure: Use of non-opioid analgesics (NSAID)
timeFrame: Within 24 hours prior to and following intervention
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
Study officials:
affiliation: University of Utah
name: Eric L Garland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Donaldson, G., & Chapman, C.R. (2013). Pain management is more than just a number. University of Utah Health/Department of Anesthesiology. Salt Lake City, Utah: Department of Anesthesiology.
citation: Garland EL, Baker AK, Larsen P, Riquino MR, Priddy SE, Thomas E, Hanley AW, Galbraith P, Wanner N, Nakamura Y. Randomized Controlled Trial of Brief Mindfulness Training and Hypnotic Suggestion for Acute Pain Relief in the Hospital Setting. J Gen Intern Med. 2017 Oct;32(10):1106-1113. doi: 10.1007/s11606-017-4116-9. Epub 2017 Jul 12.