louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05765682: Mepivacaine Vs. Bupivacaine Spinal for TKA
Official title: Mepivacaine Vs. Bupivacaine Spinal: Effect on Return of Motor Function, Time to Ambulation, and Length of Stay in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Replacement
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 160
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: OTHER

Brief summary: This study will enroll patients 18-75 years of age who are undergoing elective primary total knee replacement. The patients will be randomized to receive one of two spinal blocks: 1) mepivacaine or 2) bupivacaine. The primary goal is to determine which group arrives at recovery of motor function first. Ultimately, this study will explore if mepivacaine leads to earlier return of motor function and ultimately earlier movement and discharge times following total knee replacement.


Eligibility criteria: Inclusion Criteria:

* Ages 18-75 years of age
* Undergoing elective primary total knee arthroplasty

Exclusion Criteria:

* Inability to ambulate or impaired motor function in lower extremities prior to surgery
* Contraindication to spinal anesthetic
* Taking over 30mg oxycodone per day (or calculated MME equivalent)
* Subjects that are unable or choose not to give informed consent
* Known preoperative substance abuse
* Pregnant women
* Allergy to all opioids

Primary outcomes:
measure: Time until return of motor function following spinal placement
timeFrame: From anesthesia stop time until 7 days post-op
Secondary outcomes:
measure: Ambulation
timeFrame: from anesthesia stop time until 7 days post-op
measure: Length of Stay
timeFrame: Time from anesthesia end time to when discharge order is written, up to 30 days post-op
measure: Side Effects
timeFrame: 0-48 hours post spinal placement
measure: Pain Scores
timeFrame: Pacu to 48 hours post-spinal placement
Other outcomes:
measure: Preoperative opioid use
timeFrame: within past 90 days at time of procedure
measure: Tourniquet use
timeFrame: during procedure for up to 7 days hours after procedure ends
measure: Cement use
timeFrame: during procedure or up to 7 days hours after procedure ends
measure: Robotic or not
timeFrame: during procedure or up to 7 days hours after procedure ends
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Clinton Pillow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01487382: Special Survey for Paediatric Subjects
Official title: Special Survey for Paediatric Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-07
Enrollment: 241
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under 15 years of age requiring insulin therapy with no treatment history of insulin aspart (NovoRapid®)

Brief summary: This study is conducted in Japan. The aim of this study is to collect safety and efficacy data when using NovoRapid® (insulin aspart) in children with type 1 and type 2 diabetes under normal clinical practice conditions.


Eligibility criteria: Inclusion Criteria:

* Requiring insulin therapy
* No treatment history of NovoRapid® (insulin aspart)

Primary outcomes:
measure: Hypoglycaemic events
Secondary outcomes:
measure: HbA1c (glycosylated haemoglobin)
measure: Physicial examination
measure: Adverse events
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04665882: Nomogram to Predict Breast Cancer Related Lymphedema
Official title: Intraoperative Nomogram to Predict Breast Cancer- Related Lymphedema Based in Artificial Intelligence Image Recognition: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Axillary Lymph Node Dissection
Breast Cancer Related Lymphedema
Axillary Reverse Mapping
Lead sponsor: Wuhan University
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It has been hypothesized that damaged arm lymphatic drainage is associated with the arm lymphedema after axillary lymph node dissection (ALND). However, the majority of breast cancer patients with complete ALND has not suffered from arm lymphedema, which appears to be due to the residual arm lymph nodes that has not been removed in the axillary dissection. With the compensation of the residual arm lymph flow above the level of axillary vein, the arm lymphatic drainage could keep balance and remain normal function.

This arm lymphedema prediction model that included the protective factor, the proportion of arm lymph flow above the level of axillary vein, allows intraoperative intervention to be performed for the high-risk group. The arm lymphatics of these distinguished patients would be preserved to eliminate the occurrence of arm lymphedema in this study.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older with T1-3 invasive breast cancer;
* Clinically node-positive breast cancer, defined as positive on preoperative axillary palpation, ultrasound examination, and computed tomography scan with contrast;
* Patients who underwent mastectomy with a positive sentinel lymph node (SLN);
* Patients who underwent breast-conserving surgery containing more than two positive SLNs.

Exclusion Criteria:

* Neoadjuvant chemotherapy;
* Previous history of breast cancer.

Primary outcomes:
measure: Rate of arm lymphedema
timeFrame: Up to 5 years
measure: Rate of locoregional recurrence
timeFrame: Up to 5 years
measure: Rate of distant metastasis
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Wuhan University
name: Gaosong Wu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04648982: Psychiatric Inpatient Discharge Data - Rwanda
Official title: Psychiatric Inpatient Discharge Data - Rwanda
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mental Disorder
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Rwanda
name: Mental Health Services in the Capital Region, Denmark
First posted: 2020-12-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons that are hospitalized due to mental health concerns in Rwanda.

Brief summary: The aim is to provide a comprehensive assessment regarding the service provision and the accessibility to intensive mental health care in Rwanda

Detailed description: For a one-year period, descriptive data on all inpatients with age \> 18 years, discharged from Ndera Hospital the only inpatient psychiatric hospital in Rwanda, will be collected from files. The descriptive data includes diagnosis, duration of hospitalization, medication, addiction, insurance, Somatic- and psychiatric comorbidity, referral pathways, employment status, number of previous hospitalizations. To the investigators' knowledge, there is no descriptive data on psychiatric inpatients in the country of Rwanda. Therefore, this. Information will be crucial for understanding the service provision at the referral hospitals and the accessibility to intensive mental health care in Rwanda. The data will be anonymized and recorded - this ensures the data cannot be linked to anyone subject which supplied it.

Eligibility criteria: Inclusion Criteria:

* All patients discharged from the inpatient psychiatric unit at Ndera Hospital, Rwanda

Exclusion Criteria:

* none

Primary outcomes:
measure: Diagnosis
timeFrame: 1 year
measure: Psychiatric comorbidity
timeFrame: 1 year
measure: Somatic comorbidity
timeFrame: 1 year
measure: Alcohol or drug addiction
timeFrame: 1 year
measure: Medical drug provided during this hospitalisation
timeFrame: 1 year
measure: Who made the referral
timeFrame: 1 year
measure: Number of previous hospitalisations
timeFrame: 1 year
measure: Insurance
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Huye
country: Rwanda
facility: Ndera Hospital
city: Kigali
country: Rwanda
facility: Ndera Hospital
Study officials:
affiliation: University of Aarhus
name: Per Kallestrup, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT06400082: Topical Insulin for Postoperative Wound Healing
Official title: Investigating the Impact of Topical Insulin on Postoperative Wound Healing in Diabetic and Non-Diabetic Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Wound Complication
Insulin Resistance, Diabetes
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 74
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 parallel groups, one treated with conventional povidone iodine 10% and the other is treated with topical insulin
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the potential effect of applying topical insulin therapy on the management and healing of postoperative wounds in patients known with type 2 diabetes mellitus (T2DM) and in a parallel group without diabetes. Investigators also studied the effect of topical insulin therapy on the expression of e-cadherin and Ki67, as markers for cellular proliferation and wound repair. The levels of IL-6 and the H2O2-induced DNA damage product, 8-hydroxy-2'-deoxyguanosine (8-OHdG), were assessed as markers for inflammation and oxidative stress. Finally, histomorphological assessment of skin biopsies was also carried out.

Detailed description: The study participants will be recruited from general surgery department ,all patients with elective surgical procedure who will be admitted at the department for at least one week as it is the minimal duration of postoperative wound healing and the study will be conducted according to the regulations of ethical committee of clinical studies in the Faculty of Medicine, Cairo University

Eligibility criteria: Inclusion Criteria:

* Both males and females
* 40-60 years old
* diagnosed with type 2 DM (for the diabetic trial)
* For the diabetic trial: glycosylated hemoglobin (HBA1c) ≤7.5 %
* haemoglobin (Hb) ≥ 12 g/dl
* Patients who had a full thickness post-operative wound of ≥10 cm

Exclusion Criteria:

* Those with known history of immunodeficiency, keloid formation, or hyperkeratotic skin lesion.
* Patients who had hypersensitivity to insulin,
* Patients with severe infection,
* Patients with any severe organ dysfunction
* Patients who were admitted to ICU

Primary outcomes:
measure: Calculation of Unit Healing Time index
timeFrame: Before and after 7 days of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Omnia Azmy Nabeh
Study officials:
affiliation: Cairo University
name: Omnia Azmy Nabeh, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05718882: Lenvatinib Plus VIC-1911 in Lenvatinib-unresponsive or Lenvatinib-resistant HCC
Official title: Safety and Efficacy of Lenvatinib Combined With VIC-1911 in the Treatment of Lenvatinib-unresponsive or Lenvatinib-resistant Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Cancer
Hepatocellular Carcinoma
Resistant Cancer
Keywords: Aurora A kinase inhibitor
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 30
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
Intervention model description: Bayesian Optimal Interval design
Primary purpose: TREATMENT

Brief summary: This is a prospective clinical study aiming to test the safety and efficacy of lenvatinib in combination with Aurora kinase A inhibitor VIC-1911 in participate with lenvatinib-unresponsive or lenvatinib-resistant hepatocellular carcinoma(HCC).


Eligibility criteria: Inclusion Criteria:

(1) Unlimited gender, aged 18-75 years; (2) Meets American Association for the Study of Liver Diseases (AASLD) or European Association for the Study of the Liver (EASL) clinical diagnostic criteria of hepatocellular carcinoma; (3) Barcelona Clinic Liver Cancer (BCLC) Stage C, and there is at least one measurable tumor in the liver (long diameter ≥ 1cm);(4) Lenvatinib unresponsive or lenvatinib resistant after standard treatment; (5) Child-Pugh A or scored 7 B; (6) Eastern Cooperative Oncology Group performance status score \<= 1; (7) Platelet count \>= 60x10\^9/L, Prothrombin time prolonged \<= 6 seconds.

Exclusion Criteria:

(1) Uncorrectable coagulopathy with obvious bleeding tendency; (2) Patients need long-term anticoagulant or anti platelet therapy and cannot stop the drugs; (3) Patients with unstable or active ulcer or gastrointestinal bleeding; (4) Heart disease requiring treatment or not well controlled high blood pressure; (5) Hepatic encephalopathy or refractory ascites requiring treatment; (6) There is a clear active infection; (7) Receiving radiotherapy/chemotherapy/interventional therapy for tumor within 4 weeks before the start of the study; (8) Severe insufficiency of important organs, such as severe cardiopulmonary insufficiency; (9) Other accompanying anti-tumor treatments; (10) The investigator assessed that the patient was unable or unwilling to comply with the protocol.

Primary outcomes:
measure: Progression free survival
timeFrame: 6 months after the last subject is enrolled.
Secondary outcomes:
measure: Overall survival
timeFrame: 6 months after the last subject is enrolled
measure: Safety endpoint
timeFrame: 6 months after the last subject is enrolled
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Study officials:
affiliation: Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU
name: Qiang XIA
role: STUDY_CHAIR
References:
Clinical trial NCT01905982: The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) III-IV; part2
Official title: The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy on Dyspnoea, Activity and Parasympathetic Activities in Patients With COPD III-IV
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether different types of breathing therapies in patients with COPD III-IV decrease dyspnea, increase activity and have impact on parasympathetic activities.


Eligibility criteria: Inclusion Criteria:

* inpatient rehabilitation
* COPD (Gold stage III and IV)

Exclusion Criteria:

* severe exacerbation in the last four weeks
* acute infections
* fever
* neuritides
* severe osteoporosis
* skin disease
* manic depression

Primary outcomes:
measure: Change in BORG-Scale
timeFrame: Change from pre (minute 0) in Borg Scale and directly post intervention
Secondary outcomes:
measure: Change in lung volume
timeFrame: change from pre (minute0) in residual volume to post intervention
measure: physical activity
timeFrame: 48 h post intervention
measure: parasympathetic activities
timeFrame: baseline and post intervention
measure: Chronic Respiratory Questionnaire
timeFrame: baseline and post intervention
measure: COPD Assessment Test
timeFrame: baseline and post intervention
Other outcomes:
Locations:
city: Schönau
country: Germany
facility: Schön Klinik Berchtesgadener Land
state: Bayern
Study officials:
affiliation: Schön Klinik Berchtesgadener Land
name: Klaus Kenn, Prof. Dr.
role: STUDY_CHAIR
affiliation: Schön Klinik Berchtesgadener Land
name: Tessa Schneeberger
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02323282: The Study of Ropivacaine Median Effective Concentration in Ultrasound-guided Supraclavicular Brachial Plexus Block
Official title: The Study of Ropivacaine Median Effective Concentration in Ultrasound-guided Supraclavicular Brachial Plexus Block
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia
Keywords: Dose-response relationship
Drug
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To determine the median effective concentration of ropivacaine hydrochloride for ultrasound-guided supraclavicular brachial plexus block. The result can provide reference for choosing appropriate drug concentration in clinical anesthesia.


Eligibility criteria: Inclusion Criteria:

* ASA I or II

Exclusion Criteria:

* upper limb paresthesia
* allergic to local anesthetics
* surgery history of clavicle
* BMI\>30kg/m\^2

Primary outcomes:
measure: the affection of nerve block
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Anesthesiology,Sixth People's Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT03861182: Contribution of PRF in CDH in Children With Prothetic Patch Closure
Official title: Contribution of PRF (Platelet Rich Fibrin) in the Biological Functionalization of Prothetic Patch Closure : in Vitro Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Congenital Diaphragmatic Hernias
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Improved management of giant congenital diaphragmatic hernias (CDH) in neonates : decreased risk of morbidity and mortality due to prosthesis release. CDH is a rare disease with a still very dark prognosis, with a high rate of morbidity and mortality in giants forms linked to the release of insufficiently biologically integrated prosthesis. The biological functionalization of the prosthetic materials by host PRF would improve the biological colonization of materials and thus reduce the risk of prosthetic release.


Eligibility criteria: Inclusion Criteria:

Adult Healthy Volunteers :

- Over 18 years of age

Neonates:

* Aged between 1h of life and 28 days of life
* Born beyond 33 Week of Amenorrhea + 1day and 2kg of birth weight
* Hospitalized in the medical-surgical centre of Pediatrics of the hospital of Strasbourg
* For whom a blood sample was prescribed as part of their routine care

Exclusion Criteria:

Adult Healthy Volunteers :

* Systemic inflammatory disease
* Transient inflammatory state
* Any drug that modifies the coagulation cascade during the 48h preceding the sampling

Neonates:

* Risk of anemia \< 7g/DL
* Current anticoagulant treatment

Primary outcomes:
measure: Comparison of cell colonization between neonate biomaterials and the same biomaterials functionalized by Platelet Rich Fibrin of healthy adult volunteers.
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT02757482: Patient Training About the Safety of Warfarin Therapy
Official title: Effects of Patient Training About the Safety of Warfarin Therapy on the Patients' Warfarin Knowledge Level and International Normalized Ratio Control (INR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Warfarin Knowledge Level
International Normalized Ratio Control
Patient Training
Keywords: Patient training
Warfarin
International Normalized Ratio
Nursing
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to examine the effects of patient training about the safety of warfarin therapy on related knowledge levels and on International Normalized Ratio (INR) control.

Detailed description: Although warfarin is widely used in the treatment and prophylaxis of thromboembolic diseases, it is an oral anticoagulant with serious adverse effects. Therefore, the patient must be informed about its safe use.

A patient's level of knowledge concerning the drug plays a key role in the effective and safe use of warfarin. In the Joint Commission International (JCI) National Patient Safety Goal (NPSG) guideline for 2014 education on treatment for patients taking oral anticoagulants was recognized as a vital factor. Previous studies have reported that a positive relationship between patients' anticoagulant knowledge levels and the INR number in the therapeutic range.

For this reason there is a need for effective education programs to increase patients' knowledge concerning warfarin and to keep it up to date. Education and information services provided to patients using anticoagulants will reduce the costs of treatment by reducing risks such as thromboembolism and bleeding. When planning education, individual characteristics and needs must be kept in mind, and group education in addition to individual sessions and the use of written and visual material will increase the effectiveness of the education.

Eligibility criteria: Inclusion Criteria:

* Using warfarin for at least two months,
* Between 18 and 65 years old,
* Were literate,
* Not have a structured education about warfarin

Exclusion Criteria:

* Have structured education about warfarin,
* Have a seeing or hearing disability,
* Have a cognitive or sensory disorder,
* Have a disability affecting oral communication

Primary outcomes:
measure: Warfarin Knowledge Level Measurement
timeFrame: 2 months
Secondary outcomes:
measure: International Normalized Ratio Measurements
timeFrame: 6 months
Other outcomes:
Locations:
city: Manisa
country: Turkey
facility: CELAL BAYAR UNIVERSITY Ö.Y.P. (Teaching Staff Training Program) OFFICE
state: Muradiye
Study officials:
affiliation: Assistant professor
name: TULAY SAGKAL MIDILLI, Phd, RN
role: STUDY_DIRECTOR
References: