louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04298580: Timing Effect of Ultrasound-Guided PVB After Robotic Cardiac Surgery
Official title: Randomized, Single-Blinded Study to Evaluate the Timing Effect of Ultrasound-Guided Paravertebral Block in Patients Undergoing Robotic Mitral Valve Repair Procedure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nerve Block
Cardiac Surgery
Keywords: Postoperative pain
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is to evaluate whether the administration of ultrasound-guided paravertebral block (PVB) after surgery would produce better postoperative pain control and fast postoperative recovery after Robotic cardiac surgery. Half of participants will receive PVB before surgery, while the other half will receive PVB at the end of surgery.

Detailed description: Ultrasound-guided PVB (either before surgery, or after surgery) is the standard postoperative pain management for Robotic cardiac surgery. This technique is to inject local anesthetic (numb medication) around nerve to decrease pain. But the optimal time of PVB is unknown.

The administration of PVB before surgery can help pain control during the surgery and after surgery. But the duration of PVB could be reduced because surgery itself can last 5-6 hrs.

The PVB after surgery will not provide pain control during surgery, but may provide longer pain control after surgery, and may help participants faster recovery after surgery.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 yrs
2. ASA I-IV
3. Either gender

Exclusion Criteria:

1. Refusal to participate in the study
2. Age\< 18 yrs
3. Contraindications to regional blockage including but not limited to:

   1. Patient refusal to regional blockade
   2. Infection at the site of needle insertion
   3. Systemic infection
   4. Bleeding diathesis or coagulopathy

Primary outcomes:
measure: Durations of ICU and hospitalization
timeFrame: 2-6 days
Secondary outcomes:
measure: Pain intensity measure
timeFrame: 2-3 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05573880: The Influence of Whole-body Vibration Training on Postural Stability in People With Generalized Joint Hypermobility
Official title: The Influence of Whole-body Vibration Training on Postural Stability in People With Generalized Joint Hypermobility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypermobility, Joint
Lead sponsor: Gdansk University of Physical Education and Sport
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 36
Sex: ALL
Minimum age (years): 22
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was the assessment of muscle flexibility after 2-weeks of whole-body vibration (WBV) training in people with generalized joint hypermobility (GJH). The study included 33 participants aged 22-25 years. 12 participants were classified into the GJH group and 21 into the control group (CG). The study included the Beighton score and muscle flexibility tests: straight leg raise test (SLR), popliteal angle test (PA), and the modified Thomas test. These tests were performed before and after the short-term WBV program, which consisted of six sessions (frequency: 15 Hz and 30 Hz, amplitude 3 mm, 3 trials x 3 min.).


Eligibility criteria: Inclusion Criteria:

* healthy young adults

Exclusion Criteria:

* rheumatological disease
* orthopaedic disease
* neurological disease
* genetic disease
* cardiovascular system disease
* previous injuries of lower limbs
* surgeries of lower limbs and spine
* pain over 3 months of lower limbs and spine
* pregnancy
* implants
* the benign joint hypermobility syndrome (the Brighton criteria)
* the absence during one or more training day

Primary outcomes:
measure: Beigthon score
timeFrame: Before the main test of muscles flexibility and whole-body vibration training
Secondary outcomes:
measure: Straight Leg Raise Test
timeFrame: Twice - before and after 2-weeks of the whole-body vibration training
Other outcomes:
measure: Popliteal Angle Test
timeFrame: Twice - before and after 2-weeks of the whole-body vibration training
measure: Modified Thomas Test
timeFrame: Twice - before and after 2-weeks of the whole-body vibration training
Locations:
city: Gdańsk
country: Poland
facility: Gdansk University of Physical Education and Sport
state: Pomorskie
Study officials:
affiliation: Gdansk University of Physical Education and Sport
name: Paulina W Ewertowska, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01870362: Efficacy of a Probiotic Lozenge (Inersan) in Patients With Chronic Periodontitis
Official title: Improvement of Periodontal Health and Reduction in Periodontal Plaque Micro-flora Using a Probiotic Lozenge in Patients With Chronic Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Periodontitis
Lead sponsor: CD Pharma India Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Mahatma Gandhi Post-Graduate Institute of Dental Sciences
First posted: 2013-06-06
Enrollment: 28
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Periodontal disease is a major cause of tooth loss in humans and is one of the most prevalent diseases associated with bone loss. Following bacterial colonization, the gingiva becomes inflamed leading, in some cases, to the destruction of the alveolar bone. Periodontitis has two distinct but interconnected etiologic components, periodontopathic bacteria and host-mediated connective tissue-destructive responses to the causative bacteria and their metabolic products.

A few studies have revealed that probiotic Lactobacillus strains were useful in reducing gingival inflammation and the number of black-pigmented rods, including Porphyromonas gingivalis (Pg), in the saliva and sub-gingival plaque. Concerning periodontal conditions, its shown that application of beneficial bacteria, as an adjunct to scaling and root planing (SRP), can inhibit re-colonization of pathogens in periodontal pockets and reduce bleeding on probing.

The aim of the present study is to evaluate the improvement of periodontal health with probiotic (Inersan) lozenges, used as an adjunct to scaling and root planing \[SRP\].


Eligibility criteria: Inclusion Criteria:

* Subjects of both sexes
* Patients in the age group of 25-60 years
* Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths 5-7mm in \> 30 % of the probing sites
* The subjects should have at least 16 remaining natural teeth (minimum of at least 4 teeth per quadrant)
* Subjects in good general health

Exclusion Criteria:

* No antibiotic therapy in the past 2 months
* Medically compromised patients
* Subjects who are pregnant/ lactating
* Smokers and/or alcoholics.
* Those who had undergone any dental surgical or non-surgical therapy within 6 months prior to the start of the study.

Primary outcomes:
measure: Improvement in periodontal indices
timeFrame: 6 weeks, 12 weeks
Secondary outcomes:
measure: Microbiological indices
timeFrame: 6 weeks, 12 weeks
Other outcomes:
Locations:
city: Puducherry
country: India
facility: Mahatma Gandhi Post Graduate Institute of Dental Sciences (MGPGI)
Study officials:
affiliation: Mahatma Gandhi Post- Graduate Institute of Dental Sciences, Pondicherry
name: Grace T Paul, MBBS, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03702062: Dynamic Heart Failure Prediction With Real-time Functional Status Data in the Ambulatory Setting
Official title: Dynamic Prediction of Heart Failure Using Real-time Functional Status and Electronic Health Record Data in the Ambulatory Setting
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-10-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Heart failure is the number one cause of hospital readmission in those over 65 years of age and the current standard-of-care of weight self-monitoring is inadequate to predict exacerbation. This project aims to improve the monitoring of heart failure disease progression through the use of real-time, up-to-date data obtained both from a smart phone-based tool and from the electronic health record. The goal is to develop a low-risk, clinically validated method to estimate dynamic heart failure risk to enable the provision of earlier, more effective outpatient interventions that decrease hospitalization.


Eligibility criteria: Inclusion Criteria:

* Hospitalized for decompensated heart failure
* Age \>=18 years
* Owns a smart phone
* Willing to measure self assess 6 minute walk test weekly

Exclusion Criteria:

* None

Primary outcomes:
measure: Heart failure hospitalization
timeFrame: 12 months
Secondary outcomes:
measure: Heart failure mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Geoffrey Tison, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04264962: Yang Yin Fu Zheng Jie Du Therapy in Recurrence of Hepatocellular Carcinoma Less Than 3 cm in Diameter
Official title: Yang Yin Fu Zheng Jie Du Therapy in Recurrence of Hepatocellular Carcinoma Less Than 3 cm in Diameter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hepatocellular Carcinoma
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
Collaborators: name: Xiyuan Hospital of China Academy of Chinese Medical Sciences
First posted: 2020-02-11
Enrollment: 300
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: TREATMENT

Brief summary: Clinical research of Yang Yin Fu Zheng Jie Du therapy in recurrence of Hepatocellular Carcinoma less than 3 cm in diameter.The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng Jie Du therapy in 1 year recurrence for patients belong to Hepatocellular Carcinoma less than 3 cm in diameter.


Eligibility criteria: Inclusion Criteria:

* Meet the criteria of hepatocellular carcinoma
* Ages Eligible for Study: ≤75 years old;
* The size of the main nodule and multi-centricity (single lesion, three nodules ≤3 cm)
* After transarterial chemoembolisation (TACE) or radiofrequency ablation (RFA)
* Surgery cannot be allowed;
* Informed consent from the patient.

Exclusion Criteria:

* Serious problem of heart, lung, or kidney with severe dysfunction;
* Pregnant or child breast feeding women;
* Mental or cognitive disorders;
* Participating in other drug trials;
* Who are allergic to the study drug.

Primary outcomes:
measure: Recurrance rate
timeFrame: 1 year
Secondary outcomes:
measure: Objective response rate
timeFrame: 1 year
measure: quality of life (QOL) questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Zhiyun Yang
state: Beijing
Study officials:
References:
Clinical trial NCT03460262: Negative Pressure Wound Therapy for Prevention of Groin Infection Following Vascular Surgery
Official title: Negative Pressure Wound Therapy for Prevention of Groin Infection Following Vascular Surgery in High Risk Patient: a Randomized Control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infection Wound
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 160
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: Surgical site infection in vascular surgery is a relatively common event with reported incidence as high as 43%. When considering the groin alone, the incidence is around 20% (30% when considering any wound complication). This complication may sometimes lead to heavier complication (leg amputation, longer hospital stay, high costs...) and affects the early postoperative quality of life of the patients.


Eligibility criteria: Inclusion Criteria:

* Every high-risk patient (meeting one of the criteria of table I) undergoing vascular surgery with groin incision (without ongoing infection)

Exclusion Criteria:

* Patients who need a transverse incision before EndoVascular Aortic Repair procedure, considering that in our experience surgical site infection almost never occurs after these procedures and patients with mental incapacities.

Primary outcomes:
measure: The rate of wound complications
timeFrame: at one year
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Parla Astarci, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02457962: Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking Study
Official title: Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Solid Tumors
Hematologic Malignancies
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-05-29
Enrollment: 14266
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients being treated at Mayo Clinic with photon/ proton therapy.

Brief summary: To collect and analyze specimens that will correlate with clinical outcomes such as acute and late toxicities, quality of life, local control, and survival of patients treated with photon/proton therapy.


Eligibility criteria: Inclusion Criteria:

1. Treated with photon/proton at Mayo Clinic Rochester in Radiation Oncology
2. Radiation therapy for curative intent

Exclusion Criteria:

None

Primary outcomes:
measure: analyze acute and late toxicities using CTCAE 4.03
timeFrame: Patients will be followed for the duration of their life, an expected average of 20 years
measure: analyze quality of life using LASA-3 and FACT-E
timeFrame: Patients will be followed for the duration of their life, an expected average of 20 years
Secondary outcomes:
measure: analyze local control through tumor assessments
timeFrame: Patients will be followed for the duration of their life, an expected average of 20 years
measure: analyze survival by contacting patient and EMR (electronic medical record) review
timeFrame: Patients will be followed for the duration of their life, an expected average of 20 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Nadia N. Laack, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01668862: A Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate in Lateral Epicondylitis (Tennis Elbow)
Official title: A Prospective, Multicentric, Open Label, Randomised, Bio-Interventional Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For The Treatment Of Lateral Epicondylitis (Tennis Elbow)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Lateral Epicondylitis (Tennis Elbow)
Lead sponsor: Kasiak Research Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2012-08-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of human Platelet Lysate (HPL) in subjects with Lateral Epicondylitis (Tennis Elbow). The study is being conducted in 2 centers in India. The primary end points are Visual Analog Score (VAS) and Patient rated tennis elbow evaluation (PRTEE) score. The secondary endpoint is improvement in ultrasonography form randomization to End of study.


Eligibility criteria: Inclusion Criteria:

* Subjects with clinical diagnosis of tennis elbow within the last 3 months
* Subjects both male and female, aged 18-60 years (both inclusive)
* Subjects who are willing to give informed consent and adhere to the study protocol

Exclusion Criteria:

* Subjects aged less than 18 and more than 60 years
* Subjects with autoimmune diseases
* Subjects with immuno-compromised system
* Subjects on Anti-coagulant therapy or blood thinning medicines like Aspirin
* Subjects taking concomitant therapy that might interfere with the study results in investigators opinion or who had concomitant other injury of the tennis elbow tendons.
* Subjects who have received treatment with corticosteroid injections within the last 6 months

Primary outcomes:
measure: Change in Visual Analog Score (VAS)
timeFrame: Day 0, Month 1, Month 2, End of Study - Month 3
Secondary outcomes:
measure: Change in Ultrasonography of the lateral epicondyle region from Baseline to End of study at Month 3
timeFrame: Day 0, End of study - Month 3
Other outcomes:
measure: Patient rated tennis elbow evaluation (PRTEE Score)
timeFrame: Day 0, Month 1, Month 2, End of study-Month 3
measure: The American Shoulder and Elbow Society score
timeFrame: Dya 0, Month 1, Month 2, End of study-Month 3
Locations:
city: Thane
country: India
facility: Kasiak Research Pvt Ltd
state: Maharashtra
Study officials:
affiliation: ASMI
name: Anant Joshi, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hillway Clinic
name: Nicolas Antao, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Surya Orthopedic Clinic
name: Gauresh Palekar, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05536362: Propofol With Clonidine and Ketamine Throughout Colon Cancer Surgery
Official title: Consequences of Co-Administration of Propofol With Clonidine and Ketamine Throughout Colon Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colon Cancer
Post Operative Pain
Lead sponsor: Egymedicalpedia
Sponsor class: INDUSTRY
First posted: 2022-09-10
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: preserving hemodynamic stability, dropping post-operative pain, and dipping morphine intake
Primary purpose: TREATMENT

Brief summary: The Study Showed that combining clonidine and ketamine together can increase the likelihood of achieving a sufficient level of anaesthesia while minimizing post-operative discomfort and inflammation.

Detailed description: This study aimd to determine whether propofol infusion combined with clonidine and ketamine is more efficient in lowering the level of IL-8, preserving operation stability, and dropping post-operative pain and morphine intake.

When paralleled to propofol alone, TIVA employing propofol infusion along with pre-operation clonidine and ketamine is effective at preserving hemodynamic stability, dropping post-operative pain, and dipping morphine intake.

For this study, sixty contestants with ASA physical status I and II, ranging in age from 35 to 65, were scheduled for colon cancer operation lasting longer than 120 minutes. This study excluded participants with a history of heart, renal and liver cell failure, allergic reaction to studied drugs, and history of epilepsy, hemodynamic instability, chronic pain, or mental illness. Using a computer-generated randomization list, the patients were randomly allocated into two groups (30 patients each).

The treated group(Group T),which got intravenous anaesthesia with TCI propofol mixed with clonidine and ketamine, the control group(Group C),which received intravenous anaesthesia with TCI propofol mixed with a placebo (NaCl 0.9%) .A third party was included in this study so neither the researchers nor the research subjects are aware of the intervention which the patients got.

Eligibility criteria: Inclusion Criteria:

1. ASA physical status I and II
2. Patients with cancer colon

Exclusion Criteria:

1. participants with a history of heart, renal and liver cell failure.
2. allergic reaction to studied drugs, and history of epilepsy,
3. hydrodynamic instability,
4. chronic pain.
5. mental illness.

Primary outcomes:
measure: Measurement of Post-operative Pain
timeFrame: 24-hour analgesic after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: October 6 University Hospital
state: Cairo
Study officials:
affiliation: Department of Anesthesia and I.C.U. faculty of Medicine October six university, Egypt
name: Nirvana Elshalakany, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05952362: The Effect of Smartphone Addiction and Mental Fatigue on Working Memory in University Students
Official title: The Effect of Smartphone Addiction and Mental Fatigue on Working Memory in University Students
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smartphone Addiction
Mental Fatigue
Keywords: working memory
mental fatigue
smartphone addiction
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 120 university students

Brief summary: The aim of this study is to investigate the effects of smartphone addiction and mental fatigue on working memory in university students.

Detailed description: University students who meet the inclusion and exclusion criteria will be informed about the study and the participants who agree to participate in the study will be given the Turkish version of "Smartphone Addiction Scale", ''Mental Fatigue Scale'' and "Working Memory Questionnaire" tests, respectively. 120 university students will included in the study. To evaluate between correlation of tests will used to correlation analysis tests. In addition, it will be investigated whether there is a difference between 1.2.3 and 4th grades in terms of Smartphone Addiction, Mental Fatigue Scale and Working Memory Questionnaire

Eligibility criteria: Inclusion Criteria:

* Being a university student
* Be between the ages of 18-25
* Using a smartphone for at least one hour a day

Exclusion Criteria:

* Having musculoskeletal pain
* Having had surgery in the last 6 months
* Decline to participate in the study

Primary outcomes:
measure: Working Memory Questionnaire
timeFrame: Baseline (First assessment)
Secondary outcomes:
measure: Smartphone Addicition Scale-Short Version
timeFrame: Baseline (First assessment)
measure: Mental Fatigue Scale
timeFrame: Baseline (First assessment)
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Sciences University
Study officials:
affiliation: Kutahya Health Sciences University
name: Lütfiye AKKURT, PhD
role: STUDY_DIRECTOR
affiliation: Kutahya Health Sciences University
name: Cihan Caner AKSOY, PhD
role: PRINCIPAL_INVESTIGATOR
References: