louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06234358: A Clinical Study Carried Out in Patients Operated With Calcanail®
Official title: A Retrospective Observational Clinical Study Carried Out in Patients Operated With Calcanail® in Order to Evaluate the Safety and Performance of the Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Calcaneus Fracture
Calcaneus Deformity of Foot
Arthrosis; Localized
Lead sponsor: FH ORTHO
Sponsor class: INDUSTRY
First posted: 2024-01-31
Enrollment: 84
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient operated with the studied device between the 01/01/2012 and 01/01/2020.

Brief summary: This study is part of the Post-Market Clinical Follow-up process for the Calcanail medical device; the objective of which is to collect data on the safety and performance of the device after it has been placed on the market.

The primary objective of this study is to evaluate the safety of the device. The secondary objectives are to evaluate the clinical performance and safety of the device.

This is a research not involving the human person: observational study, retrospective, monocentric, non-comparative and national.

84 patients will be included in the study.

Detailed description: The CALCANAIL nail is an osteosynthesis nail intended for the repair of articular fractures of the calcaneus, deformities of the hindfoot and arthrosis of the hindfoot. This study aims to answer specific questions about the clinical performance, efficacy or safety of the medical device when used in accordance with its instructions for use. It will also enable us to better detect rare adverse events if necessary, as well as medium-term results.

Eligibility criteria: Inclusion Criteria:

1. Patient operated with the studied device between the 01/01/2012 and 01/01/2020.
2. Patient over 18 years old
3. Patient who has received informed information and does not object to the collection of their data in this study.

Exclusion Criteria:

Patient refusing the use of his data or deceased patient who expressed in writing during his lifetime the non-use of his medical information.

Primary outcomes:
measure: survival rate (revision)
timeFrame: 12 months
Secondary outcomes:
measure: AOFAS score: American Orthopaedic Foot & Ankle Society Score
timeFrame: 12 months
measure: Bone consolidation
timeFrame: 4 months
measure: Emergent adverse event
timeFrame: 12 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Pellegrin
Study officials:
affiliation: University Hospital, Bordeaux
name: Julien LUCAS-HERNANDEZ, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03367858: Motivational Interviewing and Neuroimaging With Adolescents
Official title: Motivational Interviewing and Neuroimaging With Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use, Unspecified
Lead sponsor: University of Rhode Island
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 204
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial to examine the impact of two brief interventions on adolescent and young adult alcohol use behaviors and related brain response. The interventions being compared are motivational interviewing (MI) and brief adolescent mindfulness (BAM).


Eligibility criteria: Inclusion Criteria:

* within the specified age range
* \>= 1 past two month binge drinking episode
* right-handed
* proficient in English
* agree to be contacted for the 3, 6, and 12 month follow ups
* informed consent of a parent/guardian, if under 18 years old
* informed assent/consent of participating youth

Exclusion Criteria:

* \> 3 past-month instances of non-nicotine and/or non-cannabis substance use (e.g., methamphetamine)
* evidence of brain injury/illness or neurological disorder including psychosis
* lifetime loss of consciousness \>= 2 min
* unremovable metal on/in body, or other functional magnetic resonance imaging (fMRI) contraindications (e.g., pregnancy)

Primary outcomes:
measure: Alcohol-related Problems
timeFrame: assessed at baseline, and 3-, 6-, and 12-month post-treatment follow ups; 12-month follow up reported
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: University of Rhode Island
name: Sarah Feldstein Ewing, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dash GF, Chung T, Yang M, Bryan AD, Hudson KA, Feldstein Ewing SW. Examining the influence of adolescent:provider alliance on youth hazardous drinking: Findings from a randomized controlled trial. Addict Behav. 2023 Jan;136:107499. doi: 10.1016/j.addbeh.2022.107499. Epub 2022 Sep 21.
Clinical trial NCT06483958: Palliative Care Protocol for Adult Patients Hospitalized in Critical Care Units.
Official title: Palliative Care Protocol for Adult Patients at High Risk of Death in Critical Care Units: A Multicentric Stepped Wedge Cluster Randomised Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End of Life Care
Critical Illness
Palliative Care
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to determine the effectiveness of a palliative care protocol in improving the quality of care of adult patients at high risk of dying hospitalized in the critical care unit.

Assessing symptom burden (dyspnea, pain and/or anxiety/agitation) until death or day 5 (whichever comes first)

Researchers will compare the impact of the palliative care protocol with standard care to see if it improves the quality of care.

Participants will:

1. Symptom management.
2. Respect for the autonomy of the patient and his/her family environment.
3. Respectful management of clinical information.
4. Provision of holistic care and support.

Detailed description: We designed a stepped wedge cluster randomized trial The study is implementation in 5 Chilean hospitals, admitting 248 patients.

Pre-intervention (control): The practices of each ICU will be maintained, until the moment that according to randomization corresponds the beginning of the intervention, in each center.

Post-intervention: Palliative care protocol to improve the quality of care

Eligibility criteria: Inclusion Criteria:

* 18 years old and older
* Hospitalization in critical care unit for more than 48 hrs.
* Medical indication of therapeutic effort limitation, defined as: a) Non-initiation or withdrawal of life support therapies: invasive mechanical ventilation, vasoactive drugs, cardiopulmonary resuscitation, renal replacement therapy.

Exclusion Criteria:

* Severe communication disorder and cultural language limitation (language other than Spanish).
* Absence of legal representative and/or caregiver.
* Brain dead patient.

Primary outcomes:
measure: Burden of symptoms present in the last 24 hours prior to death (or end of follow-up).
timeFrame: From recruitment until death or day 5 of follow up
Secondary outcomes:
measure: Family satisfaction
timeFrame: Up to 4 week after death or hospital discharge
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Verónica Rojas
state: Me
Study officials:
References:
Clinical trial NCT02984358: Chronic Mycoprotein Consumption and Nucleotide Content in Metabolic Health
Official title: Effect of Chronic Mycoprotein Consumption, and of Its Nucleotide Content, in Uric Acid Concentrations and Other Markers of Metabolic Health in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Compare chronic (one week) of a 'normal' meat diet with one week of mycoprotein consumption, with or without a reduced nucleotide content, on markers of metabolic health, such as uric acid concentrations, blood glucose control and blood lipid profiles.


Eligibility criteria: Inclusion Criteria:

* BMI between 18 and 30

Exclusion Criteria:

* On medication (except contraception)
* Smokers
* Diagnosed with any metabolic or cardiovascular conditions
* BMI \< 18 or \> 30
* Dietary restrictions (vegetarians/vegans, etc.)

Primary outcomes:
measure: Serum uric acid concentrations
timeFrame: Measured at baseline; days 2, 4 and 6 of the intervention; and after the 1 week intervention (day 8)
Secondary outcomes:
measure: Glycaemia and serum insulin - insulin sensitivity (oral glucose tolerance test)
timeFrame: Measured at baseline and after 1 week intervention (day 8)
measure: IL-6
timeFrame: Measured at baseline and after 1 week intervention (day 8)
measure: 24 h blood glucose homeostasis - measured using a Dexcom CGMS
timeFrame: Measured 5 days at baseline (habitual data) and 5 days during the intervention (days 3 - 7)
measure: Metabolomics (using Nuclear Magnetic Resonance - NMR)
timeFrame: Measured at baseline; days 2, 4 and 6 of the intervention; and after the 1 week intervention (day 8)
Other outcomes:
Locations:
Study officials:
References:
citation: Coelho MOC, Monteyne AJ, Kamalanathan ID, Najdanovic-Visak V, Finnigan TJA, Stephens FB, Wall BT. High dietary nucleotide consumption for one week increases circulating uric acid concentrations but does not compromise metabolic health: A randomised controlled trial. Clin Nutr ESPEN. 2022 Jun;49:40-52. doi: 10.1016/j.clnesp.2022.04.022. Epub 2022 Apr 25.
Clinical trial NCT05731258: Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen
Official title: Clinical Observational Study of Postoperative Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Liposomal Doxorubicin
Efficacy
Safety
Postoperative Adjuvant Treatment
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Early breast cancer patients who required four cycles of chemotherapy after curative resection of breast cancer

Brief summary: The goal of this observational study aims to observe and evaluate the efficacy and safety of a liposomal doxorubicin containing regimen in the postoperative adjuvant treatment of breast cancer patients.


Eligibility criteria: Inclusion Criteria:

1. Female, aged 18-75 years;
2. Primary breast cancer diagnosed histopathologically;
3. Adjuvant chemotherapy regimens include liposomal doxorubicin;
4. ECoG PS score: 0-1 points;
5. Left ventricular ejection fraction (LVEF) ≥ 55%;
6. Estimated survival ≥ 6 months;
7. Major organ function is normal, i.e. meets the following criteria:

   ① And white blood cells ≥ 4.0 × 10 9 / L, neutrophil count (ANC) ≥ 1.5 × 10 9 /L；② Platelets ≥ 100 × 10 9 /L；③ And hemoglobin ≥ 10 g / dl; ④ Serum creatinine ≤ 1.5 × ⑤ the upper limit of normal (ULN) Mmol / L and aspartate transaminase (AST) ≤ 2.5

   × ULN；⑥ Alanine transaminase (ALT) ≤ 2.5 × ULN；⑦ Total bilirubin ≤ 1.5 × ULN；⑧ Serum creatinine ≤ 1.5 × ULN；
8. Subjects voluntarily join this study, sign the informed consent form, have good compliance and cooperate with follow-up.

Exclusion Criteria:

1. Pregnant, lactating patients;
2. Breast cancer has been found to have distant metastasis;
3. Those with peripheral nervous system disorders caused by the disease or with a history of significant mental disorders and central nervous system disorders;
4. Those with severe infection or active peptic ulcer requiring treatment;
5. Allergic to chemotherapy drugs;
6. Cancer free period less than 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the cervix;
7. Severe liver disease (e.g., cirrhosis, etc.), renal disease, respiratory disease, or uncontrolled diabetes;
8. Patients who are participating in other clinical trials or within a month.

Primary outcomes:
measure: Cardiac safety
timeFrame: 10 years
Secondary outcomes:
measure: Overall survival
timeFrame: 10 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliate Hospital of Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT03738358: Clinical Study of 12-week Trehalose Intake in Patients With Fatty Liver Disease
Official title: A 12-week, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study to Evaluate the Efficacy and Safety of Trehalose in Patients With Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-alcoholic Fatty Liver
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 39
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical study will be conducted to evaluate the efficacy and safety of trehalose in patients with fatty liver disease. After 12-week intake, subjects will be checked up fat content in liver using CT scan.


Eligibility criteria: Inclusion Criteria:

* Age between 19-year-old and 79-year-old
* Weight (≥50kg)
* Is diagnosed as fatty liver on ultrasonography within 24 weeks from screening day
* Has willingness and ability to participate whole clinical study period
* Willing to give informed consent form

Exclusion Criteria:

* Patient with alcoholic fatty liver
* Patient with inflammatory bowel disease
* Is required treatment for like liver, kidney, digestive system, circulatory system, respiratory system, endocrine system(except diabetes), musculoskeletal, neuropsychiatry, or hemato-oncology etc., which is able to effect on clinical study
* Has any medical history with virus or toxic hepatitis
* Has any medical history of gastrointestinal surgery (except simple appendectomy \& repair of hernia)
* Has medical history of malignant tumor (except non-melanoma skin cancer) within the last 5 years from the screening day
* Took any drugs (UDCA, silymarin, omega-3, fenofibrate etc.) which is decided as unsuitable drug for combined-dose by investigator
* Over 4 times of maximum reference range of ALT or AST
* Average drinking quantity per week \> alcohol 140 g
* Pregnant or nursing women
* Is currently participating into another clinical study
* Being made a decision from investigator as unsuitable to participate this study

Primary outcomes:
measure: Change in liver fat content scanned by CT
timeFrame: Screening (baseline) and 12 weeks
Secondary outcomes:
measure: Change in ALT and AST
timeFrame: 0 (baseline) and 12 weeks
measure: Change in homeostatic model assessment-insulin resistance (HOMA-IR)
timeFrame: Screening (baseline) and 12 weeks
measure: Change in total cholesterol, LDL, HDL, triglyceride (TG) and free fatty acid
timeFrame: 0 (baseline), 6 and 12 weeks
measure: Change in BMI
timeFrame: 0 (baseline), 6 and 12 weeks
measure: Change in visceral fat and subcutaneous fat levels
timeFrame: 0 week and 12 weeks
measure: Adverse event (AE)
timeFrame: 0 week, 6 weeks, and 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02763358: Assessing the Bite Counter
Official title: Assessing the Bite Counter as a Tool for Food Intake Monitoring: Phase II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Weight Loss
Keywords: obesity
weight loss
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Clemson University
First posted: 2016-05-05
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is designed to test the usability of the Bite Counter in an attempt to reduce participants' daily bites while also increasing their daily steps.

Detailed description: Self-monitoring is an important component of behavioral management of obesity. The Bite Counter is a wrist-worn device which detects the motions characteristic of taking a bite of food or a drink of liquid, to provide the wearer with a cumulative count of bites and sips over the day. In earlier studies the method was shown to accurately count bites across a wide variety of foods, utensils and subject demographics, and to provide an unbiased intake measurement. The proposed work will continue to improve the bite counting method by adapting to varying eating rates, develop a self-managed bite count-based weight loss protocol, and perform an independent test of the protocol. An improved Bite Counter device will also measure activity (steps).

Eligibility criteria: Inclusion Criteria:

* Participants must be between the ages of 18 and 70 (inclusive)
* Participants must have a BMI between 27 and 35
* Participants must have regular and reliable access to a Windows-based computer with an internet connection with USB connectivity
* Participants must be currently consuming at least 1400 calories per day
* Participants must demonstrate adequate compliance with using Bite Counter and uploading data during the two-week baseline period

Exclusion Criteria:

* Participants must have no history of any eating disorder
* Participants must not have participated in a weight loss program within the month prior to baseline

Primary outcomes:
measure: Reduction in the numbers of bites per day as displayed on the Bite Counter
timeFrame: 15 weeks
Secondary outcomes:
measure: Increase in the number of steps per day as displayed on the Bite Counter
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina-Weight Management Center
state: South Carolina
Study officials:
affiliation: Medical University of South Caolina
name: Patrick O'Neil, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02336958: Ultrasound Guided Intermediate Cervical Plexus Block and Additional Perivascular Local Anesthetic Infiltration
Official title: Ultrasound Guided Intermediate Cervical Plexus Block -Randomized Evaluation Concerning the Significance of Additional Perivascular Local Anesthetic Infiltration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Stenosis
Keywords: cervical plexus
regional anesthesia
ultrasound
carotid surgery
Lead sponsor: Helios Research Center
Sponsor class: OTHER
First posted: 2015-01-13
Enrollment: 40
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: For ultrasound guided intermediate cervical plexus block this randomized comparison is testing the hypothesis, that an additional perivascular infiltration is associated with increased block quality.

Detailed description: The innervation of the neck is complex and involves the cervical and the brachial plexus as well as cranial nerves. So is the wall of the carotid arteries innervated by vagal and glossopharyngeal nerve as well as the sympathetic trunk. When carotid surgery was performed under regional anesthesia, so additional infiltration of local anesthetic by the surgeon was common, particularly during preparation of the carotid arteries.

Introduction of ultrasound guidance made it possible to guide the needle directly to the vascular wall. But this procedure is considered very demanding, because of guiding the needle in an anatomical region with artifacts (because of calcification), sudden movements (e.g. because of swallowing) and compromised coagulation (antithrombotic medication). On the other side there are no clinical data proving the benefit of an additional perivascular infiltration with local anesthetic. Therefore, this investigation is testing the hypothesis, that an additional perivascular infiltration is associated with increased block quality.

Eligibility criteria: Inclusion Criteria:

* carotid surgery (symptomatic and asymptomatic carotid stenosis)
* adult patients (18 years or older)
* ASA-risk-groups I-IV
* informed consent

Exclusion Criteria:

* drug allergy: local anesthetics
* pregnancy, lactation period
* participation in other studies
* addiction to drugs or alcohol
* non-cooperative patients
* no approval to regional anesthesia

Primary outcomes:
measure: Number of Patients With Required Supplementation of Local Anesthetic by Surgeon
timeFrame: during the intraoperative period
measure: Amount (ml) of Local Anesthetic Supplemented by Surgeon
timeFrame: during the intraoperative period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Helios Kliniken Schwerin, Klinik für Anästhesiologie und Intensivtherapie, Wismarsche Strasse 393-7, 19049 Schwerin, Germany
name: Ronald Seidel, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: