louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02277977: Evaluation of Impaired Microcirculation During Septic Shock With Contrast Enhanced Ultrasound
Official title: Messung Von Mikrozirkulationsstörungen im Septischen Schock Mit Kontrastmittel- verstärkter Sonographie Evaluation of Impaired Microcirculation During Septic Shock With Contrast Enhanced Ultrasound
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sepsis
Keywords: sepsis
septic shock
contrast-enhanced ultrasound
microcirculation
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2014-10-29
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Microcirculatory disorders play a central role in the pathogenesis of sepsis and septic shock. Without adequate therapy that may lead to multi-organ failure and death. Therefore useful therapeutic measures aim to improve the microcirculation, to avoid tissue hypoxia and thus multiple organ failure or death. Clinically, the microcirculation can currently be indirectly evaluated using the diuresis and metabolic parameters (eg, lactate). The aim of the present study is to measure the microcirculation in septic shock by means of contrast-enhanced sonography of the calf muscles. For this purpose, the method is applied to 24 subjects during and after septic shock. It will be investigated in this study whether the microcirculation measurement with ultrasound contrast reflects the severity of the disease. As well as to evaluate whether the use of this diagnostic method could lead to better treatment of the septic shock.


Eligibility criteria: Inclusion Criteria:

* septic shock

Exclusion Criteria:

* myocardial infarction

Primary outcomes:
measure: Contrast transit time during and after septic shock
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Freiburg
name: Daniel Duerschmied, MD, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02866877: Effects of Augmented Renal Clearance on Pharmacokinetic and Pharmacodynamic Properties of Levetiracetam in Subarachnoid Hemorrhage
Official title: Effects of Augmented Renal Clearance on Pharmacokinetic and Pharmacodynamic Properties of Levetiracetam in Subarachnoid Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subarachnoid Hemorrhage
Keywords: augmented renal clearance
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have suffered a non-traumatic subarachnoid hemorrhage requiring strict intake and output monitoring and admission to the neuro-intensive care unit

Brief summary: This study evaluates the pharmacokinetic profile of levetiracetam in critically ill patients who have suffered a subarachnoid hemorrhage. The patients will be evaluated for development of augmented renal clearance and the effects and duration of effects this may have on levetiracetam clearance.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with non-traumatic subarachnoid hemorrhage requiring levetiracetam for seizure prophylaxis or treatment
* Presentation to University of Colorado Hospital within 48 hours of subarachnoid hemorrhage
* Adults ages 18 to 89 years
* Anticipated length of stay ≥ 48 hours
* Informed consent provided by the patient or patient's designated medical proxy

Exclusion Criteria:

* Pregnancy
* Patients receiving renal replacement therapy
* Brain death or imminent brain death expected ≤48 hours
* Patient with history of nephrectomy or renal transplant

Primary outcomes:
measure: Change in systemic levetiracetam clearance over time
timeFrame: 0-20 days
Secondary outcomes:
measure: Change in urinary clearance of levetiracetam and creatinine
timeFrame: 0-20 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado School of Pharmacy
name: Edward T Van Matre, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00398177: Clinical and Pathologic Studies in Non-Hodgkin's Lymphoma and Hodgkin's Disease
Official title: Clinical and Pathologic Studies in Non-Hodgkin's Lymphoma and Hodgkin's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma, Non-Hodgkin
Hodgkin's Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: The Leukemia and Lymphoma Society
name: Biospect Inc
First posted: 2006-11-10
Enrollment: 9999
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any type of NHL or Hodgkin's disease.

Brief summary: The purpose of this study is to characterize the molecular and cell biology of the tumor cells in lymphoma.

Detailed description: This research involves the study of lymphoma cells in order to better understand how the disease grows and spreads. This study may lead to the development of special materials that could be used, in the future, to treat lymphoma or to follow the response of lymphoma to treatment.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Hodgkin's disease or non-Hodgkin's lymphoma, any cellular classification, any stage, any grade.
* Adult or pediatric patients receiving lymph node excision for purposes other than cancer therapy (i.e. tonsillectomy, sleep apnea).
* A routine procedure for tissue collection is planned.
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Patients without NHL or Hodgkin's disease

Primary outcomes:
measure: Collection of tumor tissue to characterize the molecular and cell biology of tumor cells in lymphoma.
timeFrame: The study will continue indefinitely.
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Ronald Levy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kurtz DM, Scherer F, Jin MC, Soo J, Craig AFM, Esfahani MS, Chabon JJ, Stehr H, Liu CL, Tibshirani R, Maeda LS, Gupta NK, Khodadoust MS, Advani RH, Levy R, Newman AM, Duhrsen U, Huttmann A, Meignan M, Casasnovas RO, Westin JR, Roschewski M, Wilson WH, Gaidano G, Rossi D, Diehn M, Alizadeh AA. Circulating Tumor DNA Measurements As Early Outcome Predictors in Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2018 Oct 1;36(28):2845-2853. doi: 10.1200/JCO.2018.78.5246. Epub 2018 Aug 20.
Clinical trial NCT02467777: Comparison of Forced Air and Conductive Patient Heating Systems During Ambulatory Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia
Keywords: orthopaedics
post-operative warming
Lead sponsor: Fox Valley Orthopedic Institute
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 50
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: Comparison of forced air and conductive warming devices in outpatient orthopaedic surgeries.

Detailed description: Patients will be randomized into either the Forced Air group (FA) or Conductive Heat group (CH). Randomization will be based on computer-generated codes that will be maintained in sequentially numbered opaque envelopes. Fifty patients will be recruited with 25 patients being randomized into each group.

In patients assigned to the FA group, a Bair Hugger (Arizant Medical, Inc., Eden Prairie, Minnesota) forced-air cover will be positioned over the upper body (if lower extremity surgery) or lower body (if upper extremity surgery). The forced-air blower will be set and activated per standard practice usually after prepping and draping.

In patients assigned to the CH group, a VitaHeat (VitaHeat, Inc, Aurora, IL) conductive heating device will be placed under the torso of the patient. The device will be set and activated per standard practice usually just after positioning of the patient on the operating table.

Patients in both groups will be otherwise draped per surgical routine. Ambient temperature will be maintained near 20°C. Temperatures will be recorded using a temporal artery thermometer.

Eligibility criteria: Inclusion Criteria:

* patients undergoing orthopaedic outpatient surgeries over 18 years old

Exclusion Criteria:

* allergic to material of bair hugger

Primary outcomes:
measure: Temperature
timeFrame: Intra-Operative
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: United States
facility: Fox Valley Orthopedics
state: Illinois
Study officials:
References:
Clinical trial NCT06038877: Opinions and Representations of Advanced Practice Nurses (IPA) in Nephrology in France on Clinical Research
Official title: Opinions and Representations of Advanced Practice Nurses (IPA) in Nephrology in France on Clinical Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Caregivers
Keywords: Advanced practice nurse
Clinical research
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced Practice Nurses in nephrology in France

Brief summary: This single-center study will identify the representations and opinions of Advanced Practise Nurses (IPA) in nephrology in the Auvergne Rhône Alpes (AURA) region about clinical research. The study will consist of individual semi-directive interviews with Advanced Practise Nurses (IPA).


Eligibility criteria: Inclusion Criteria:

* Hold a state diploma in advanced practice nursing
* Have been working at the health facilities for at least 3 months
* Working in France

Exclusion Criteria:

- Refusal to participate in the study

Primary outcomes:
measure: Speeches collected during semi-structured interviews
timeFrame: 5 months
Secondary outcomes:
measure: Evaluation of the responses to the follow-up questions
timeFrame: 5 months
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Marion BONJEAN, nurse
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03030677: Establishing Technique for PECS2 Catheter Insertion
Official title: Establishing Technique for PECS Type 2 (Serratus Block) Catheter Insertion With Ultrasound Guidence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastcancer
Phyllodes Breast Tumor
Keywords: pecs block
breast surgery
ultrasound guidence
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 80
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators are trying to establish an easy technique for insertion of a catheter for continuous infusion while performing pectoral type 2 (serratus) block, as a post operative pain controlling measure for cases undergoing simple mastectomy, using ultrasound guidence

Detailed description: As the space between the pectoralis minor and the serratus anterior is a fashial plane with a connective tissue occupying. we are trying to demonstrate a simple technique for inserting a catheter within that fashial plane and making sure of the catheter position, to ensure post operative analgesia for cases performing simple mastectomy.

Now the Pectoralis type 2 block (PECS type 2) is an established technique as regional block technique for chest wall procedures.

We are trying to maximizing the benefit of the block with a catheter insertion to use it for continuous infusion of bupivacaine for controlling post operative pain in cases performing simple mastectomy procedure

Eligibility criteria: Inclusion Criteria:

* Female patient scheduled for simple mastectomy
* Accepted performing the block

Exclusion Criteria:

* Patients on anticogulants
* Chest wall infection
* Patient refusal

Primary outcomes:
measure: successful catheter insertion
timeFrame: during time of performing the block
Secondary outcomes:
measure: Number of attempts
timeFrame: during time of performing the block
measure: Duration needed for insertion
timeFrame: during time of performing the block
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alaini Hospitals
Study officials:
affiliation: Kasr Al Aini Faculty of Medicine
name: Mohamed Ah Mansour, ass.prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03087877: Evaluation of the Dexcom G6 Continuous Glucose Monitoring System With a Non-Interferent Sensor
Official title: Evaluation of the Dexcom G6 Continuous Glucose Monitoring System With a Non-Interferent Sensor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: DexCom, Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-23
Enrollment: 70
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: The objective of the study is to demonstrate effectiveness of the G6 sensor membrane, in preventing acetaminophen's interference effect on glucose sensing.

Detailed description: The interference effect of the sensor will be evaluated by comparing the bias in the glucose values exhibited from the G6 CGM system after administration of acetaminophen. Bias will be evaluated by comparing CGM values to a laboratory referenceusing venous sample measurements.

Eligibility criteria: Inclusion Criteria:

* Ages 18 or older
* Diagnosis of diabetes

Exclusion Criteria:

* Pregnancy
* Known gastroparesis
* Abnormal liver function

Primary outcomes:
measure: Interference Effect for the G6 CGM
timeFrame: 6 hrs post dose
Secondary outcomes:
measure: Mean of sensor minus YSI values (bias) for various time periods
timeFrame: 6 hrs post dose
measure: Duration of interference effect for the G6 CGM
timeFrame: 6 hrs post dose
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR
state: California
city: Santa Barbara
country: United States
facility: William Sansum Diabetes Center
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Renton
country: United States
facility: Rainier Clinical Research Center Inc
state: Washington
Study officials:
affiliation: DexCom, Inc.
name: David Price, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03134677: The Effects of Different Anesthetic Techniques on QT, Corrected QT (QTc), and P Wave Dispersions in Cesarean Section
Official title: The Effects of Different Anesthetic Techniques on QT, Corrected QT (QTc), and P Wave Dispersions in Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Caesarean Section
Anesthesia; Reaction
Keywords: Spinal anesthesia
General anesthesia
P wave dispersion
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effects of different anesthetic techniques on QT, QTc, and Pwd in cesarean section. Half of participants received general anesthesia, while the other half received spinal anesthesia Electrocardiography (ECG) recordings were performed at preoperative, 5, 15, 30 min after initiation anesthesia and 30 min post-operatively. Hemodynamic state were also recorded at the same time intervals. QT, corrected QT (QTc), QT dispersion (QTd), QTc dispersion (QTcd), P-wave dispersion (Pwd), corrected JT interval, T wave (Tp-e), transmular dispersion of repolarization durations were measured from ECG records at predetermined time intervals of spinal or general anesthesia.

Detailed description: The anesthetic drugs used according general or regional anesthesia techniques can display proarrhythmic and antiarrhythmic effects by inducing cardiac electrical signals with different pathways.In addition, comorbid disease, hormonal changes, surgery procedures, and drug therapy can all cause arrhythmia in the intraoperative period. Likewise, pregnancy causes many changes hormonal and physiological in women. Hemodynamic and hormonal changes during pregnancy can cause effects proarrhythmogenic that cause premature atrial and ventricular beats to develop.

Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists physical status I-II
2. ages 20-40 years
3. parturient patients

Exclusion Criteria:

1. spinal cord and peripheral nervous system diseases;
2. hypovolemic and hemorrhagic shock;
3. increased intracranial pressure;
4. severe anemia;
5. systemic infection;
6. scoliosis;
7. congenital spinal anomalies;
8. vertebral colon metastatic lesions;
9. anticoagulant drug use;
10. diabetes mellitus;
11. hypo/hyperthyroidism;
12. atrial and/or ventricular hypertrophy on ECG;
13. cardiomyopathy;
14. valvular disease;
15. cardiac failure or chronic disease;
16. cardiomegaly
17. used medication causing QT interval prolongation.

Primary outcomes:
measure: Measurement of perioperative electrocardiogram changes
timeFrame: Preoperative, intraoperative and postoperative 30 min.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Trakya University Medical Faculty
name: Sevtap Hekimoglu Sahin, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04684277: Internet-Based Interventions for MDD
Official title: Effectiveness of Internet-Based Interventions for Treatment Compliance and Outcomes of Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Medication Adherence
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The acute and remission depression patients of 18-65 years old were recruited. At the time of enrollment, the demographic, symptomatic, neuropsychological and medication adherence data was collected. After the completion of the baseline assessment and examination, the patients were given antidepressant treatment or antidepressant treatment combined with Internet-based interventions. Clinical evaluation was performed at 1, 3 months (acute patients) and 6, 12 months (remission patients) after treatment, including the medication adherence, therapeutic efficacy, recurrence rate and functional rehabilitation. Through above work, this research is expected to provide clinicians with a set of Internet generalized technologies to improve the compliance and clinical outcomes of patients with depression, and to provide patients with treatment and management of the entire disease cycle.


Eligibility criteria: Inclusion Criteria:

* age 18-65 years old, acute (HAMD17 \> 17) and remission (HAMD17 \< 8) depression

Exclusion Criteria:

* other mental illnesses, serious somatic illnesses

Primary outcomes:
measure: HAMD17 reduction ratio
timeFrame: 3 months
measure: recurrence rate
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yunai Su
Study officials:
affiliation: Institute of mental health, Peking University
name: Tianmei Si, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02682277: Efficacy of Polyglucosamine Long Term Treatment
Official title: Efficacy of Polyglucosamine for Weight Loss - in a Randomized, Double-blind, Placebo-controlled Clinical Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
body weight
overweight
weight loss
polyglucosamine
L112
caloric restriction
physical activity
Lead sponsor: Certmedica International GmbH
Sponsor class: INDUSTRY
First posted: 2016-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The polyglucosamine, specification L112, is a medical device and in this clinical trial used for weight reduction in moderately obese participants following a long term treatment lasting 12 months. The rationale for this study is to show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals.

Detailed description: Two groups of subjects were compared. A comparable diet condition, consisting of 10 % reduction of caloric intake was followed, according to a questionnaire based on the weekly number of servings. No modification of physical activity was requested.

One group had to take the polyglucosamine tablets and the other group placebo tablets for at least 12 months. It is known, that polyglucosamine is a fat binder acting in a physical-chemical manner, the positive charged fiber is bound to the negative charged dietary fat and this complex is unable to pass the gut wall into the body but is naturally excreted,hence this energy is not available. Therefore, this medical device should show a measurable reduction in body weight.

Eligibility criteria: Inclusion Criteria:

* BMI \>30 and \< 35
* waist circumference of more than 88 cm for women and greater than 102 for men

Exclusion Criteria:

* pregnancy or breast-feeding
* alcohol abuse
* drug abuse or drug addiction
* inability to fulfill the criteria of the trial protocol
* cancer diseases
* malignant tumors
* pre-existence of chronic intestinal disease
* known hypersensitivity reactions to crustaceans

Primary outcomes:
measure: Number of participants who could reduce their body weight by 10 or more per cent compared to the initial body weight.
timeFrame: 12 months
Secondary outcomes:
measure: Change of body weight in kg
timeFrame: 12 months
measure: Change of BMI
timeFrame: 12 monts
measure: Reduction of waist circumference
timeFrame: 12 months
Other outcomes:
Locations:
city: Rende
country: Italy
facility: MAP Center
state: Cosenza
Study officials:
affiliation: Irwine Labs University of Chieti
name: Gianni Belcaro
role: PRINCIPAL_INVESTIGATOR
affiliation: Loyola University School of Medicine-Chicago
name: Umberto Cornelli, MD
role: STUDY_DIRECTOR
References: