louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02633514: Adjuvant Treatment for Incomplete Resection Thymoma or Thymic Carcinoma
Official title: A Randomized Phase III Study of Adjuvant Radiotherapy Versus Adjuvant Radiochemotherapy in Patients With Incomplete ResectionThymoma or Thymic Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Thymoma and Thymic Carcinoma
Keywords: thymoma
thymic carcinoma
adjuvant radiotherapy
adjuvant radiochemotherapy
incomplete resection
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2015-12-17
Enrollment: 1
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: This study is designed to investigate whether adjuvant radiochemotherapy after incomplete resection has a better survival than adjuvant radiotherapy for thymoma or thymic carcinoma.

Detailed description: The previous trials have showed that radiotherapy was significantly associated with prolonged OS and chemotherapy is playing an increasing role in treatment of patients with thymoma or thymic carcinoma.However,whether patients with thymoma or thymic carcinoma could benefit from adjuvant radiochemotherapy after incomplete resection remains controversial. The purpose of this study is to investigate whether adjuvant radiochemotherapy after incomplete resection can improve survival for thymoma or thymic carcinoma.

Eligibility criteria: Inclusion Criteria:

18\~75 years old; Eastern Cooperative Oncology Group performance status of 0 to 2; Pathologically confirmed ; incomplete resection (R1 or R2);have adequate bone marrow, hepatic, and renal function;Patients receive incomplete resection within 3 months; Written informed consent.

Exclusion Criteria:

Patients with distant metastases; Patients underwent radiotherapy or chemotherapy; Patients who have malignancy history excluding carcinoma in situ of cervix in the previous five years; Active clinical pulmonary infection; Pregnant or nursing.

Primary outcomes:
measure: Progression free survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Kailiang Wu
state: Shanghai
Study officials:
affiliation: Fudan University
name: Kailiang Wu, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00147914: Comparison Study Between Cefdinir & Amoxicilline/Clavulanate in Acute Sinusitis and Assessment of Quality of Life
Official title: A Comparison Study Between Cefdinir and Amoxicilline/Clavulanate in Patients With Acute Sinusitis and Assessment of Quality of Life (QOL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Bacterial Sinusitis
Keywords: Acute bacterial sinusitis
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2005-09-07
Enrollment: 100
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: This study is a comparison between two commonly used antibiotics (Cefdinir vs. Amoxicillin/Clavulanate) in patients with acute sinus infection, surveying quality of life. The hypothesis is that the two treatments would be at the least equivalent based on clinical outcome measures of improvement in quality of life.

Detailed description: The purpose if this investigation is to evaluate the rate of improvement ub Quality of LIfe (QOL) in two different medications, a 10-day course of Cefdinir 300 mg PO BID versus a 10-day course of Amoxicillin/Clavulanate 1000 mg/62.5 mg XR BID, in the treatment of acute bacterial sinusitis.

Eligibility criteria: Inclusion Criteria:

* Male and female outpatient adults greater than 18 years old fulfilling the case definition for acute bacterial sinusitis
* Case definition includes clinical signs and symptoms, radiographic findings and collection of purulent material from the sinus

Exclusion Criteria:

* Symptoms less than 7 days and more than 3 weeks
* History of sinus surgery within 3 months
* History of frequent sinus infections (more than 2 episodes within the last 6 months)
* History of kidney and liver disease
* Pregnant and nursing women
* Pre-existing disease that could predispose to sinus infections (cystic fibrosis or nasal polyps
* Immunosuppressed patients
* History of allergy to either drug. Patients with a documented history of allergies to either penicillin or cephalosporins will be excluded.

Primary outcomes:
measure: Improvement in quality of life
timeFrame: At baseline and within 1 week of completing treatment
measure: SNOT 20 questionnaire
timeFrame: At baseline and within 1 week of completing treatment
Secondary outcomes:
measure: Clinical signs and symptoms alleviated
timeFrame: At baseline and within 1 week of completing treatment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Jacquelynne Corey, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tantilipikorn P, Fritz M, Tanabodee J, Lanza DC, Kennedy DW. A comparison of endoscopic culture techniques for chronic rhinosinusitis. Am J Rhinol. 2002 Sep-Oct;16(5):255-60.
citation: Vaidya AM, Chow JM, Stankiewicz JA, Young MR, Mathews HL. Correlation of middle meatal and maxillary sinus cultures in acute maxillary sinusitis. Am J Rhinol. 1997 Mar-Apr;11(2):139-43. doi: 10.2500/105065897782537133.
Clinical trial NCT05128214: Aspirin Thromboprophylaxis After First-line Total Hip and Knee Replacement
Official title: Aspirin Thromboprophylaxis After First-line Total Hip and Knee Replacement. Comparison With Baseline Low Molecular Weight Heparin Prophylaxis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hip and Knee Prosthesis Implantation
Keywords: Hip prosthesis implantation
Knee prosthesis implantation
Aspirin thromboprophylaxis
Heparin prophylaxis
Thromboembolic complications
Bleeding complications
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient operated on for a first-line total hip or knee replacement by the principal investigator;

Brief summary: Annually, more than 100,000 total hip prostheses (THA) and more than 100,000 total knee prostheses (TKA) are implanted for osteoarthritis in France, and these figures are set to increase significantly in the future as in all industrialized countries. . Venous thrombosis is a potentially serious complication after PTH and PTG, justifying various prophylactic measures. In France, aggressive prophylaxis with low molecular weight heparin (LMWH) or direct oral anticoagulants (DOA) was until recently recommended, because this drug is considered to be the most effective, at the cost of a bleeding risk implicitly assumed but often poorly. evaluated. A recent publication suggests that the risk of bleeding is currently greater than the risk of a thromboembolic event.

More recently, foreign or international recommendations have broadened the range of these recommendations, notably by introducing aspirin as a possible prophylactic agent. While this molecule is potentially less effective than LMWHs or ADOs, it could decrease the risk of iatrogenic hemorrhage. The introduction of enhanced recovery procedures after surgery (RAAC) could decrease the risk of thrombosis without modifying the risk of bleeding, and thereby improve the cost-benefit ratio of aspirin, justifying its recent inclusion in the current French recommendations when The operated follows such a protocol.


Eligibility criteria: Inclusion criteria:

* Adult patient (≥ 18 years old);
* Patient operated on for a first-line total hip or knee replacement by the principal investigator;
* Patient not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion criteria:

- Subject having expressed opposition to participating in the study

Primary outcomes:
measure: Study of the postoperative thromboembolic complications after implantation of hip and knee prostheses
timeFrame: Files analysed retrospectively from July 01, 2016 to December 31, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Orthopédique Pédiatrique - Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT03799614: Vibration Impact on Parkinson's Tremor
Official title: Vibration Impact on Parkinson's Tremor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to test the safety, tolerability and efficacy of vibration (delivered by an experimental device called RMBand that is worn on the subject's arm) on parkinsonian tremor. The RMBand was developed by Resonate Forward, LLC (RF). This RMBand is designed to administer a vibration to the wearer to decrease or stop tremor in persons with Parkinson's disease (PD).

Detailed description: Participation will be completed in one visit at VCU Parkinson's and Movement Disorders Center. A baseline Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) will be taken prior to vibration therapy. The RMBand (experimental device) will be placed on the arm of the participant to provide the vibration therapy. The MDS-UPDRS Part III will be repeated both during and after the therapy. Participants will be asked to provide feedback about the device, the therapy session and how they are feeling.

Eligibility criteria: Inclusion Criteria:

* Parkinson's disease (PD) as diagnosed by a movement disorder specialist
* Tremor caused by their Parkinson's disease
* Ability to provide informed consent

Exclusion Criteria:

* Known diagnosis of Parkinson Plus Syndrome
* Dementia
* Other known non-PD cause of tremor
* Other known non-PD cause of limb dysfunction
* Presence of implantable cardiac device, severe neuropathy or sensory loss that would prevent perception of vibration stimulus
* Non-English speaker
* Prisoners
* Pregnant women

Primary outcomes:
measure: Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)
timeFrame: This rating scale will be used at baseline, 5 minutes after vibration starts, and 5 minutes after vibration is turned off.
measure: Clinical Rating for Tremor
timeFrame: Data collection times were baseline, 5 minutes after vibration start (vibration duration was 20 minutes), 5 minutes after vibration was stopped. .
measure: Objective Measurement of Tremor Frequency (Hz)
timeFrame: Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment.
measure: Objective Measurement of Tremor Amplitude (mm).
timeFrame: Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Ingrid Pretzer-Aboff, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04532814: Exercise-stimulated Muscle Glucose Uptake in Upper Body Obesity
Official title: Exercise-stimulated Muscle Glucose Uptake in Upper Body Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Upper Body Obesity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-08-31
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is aimed to determine whether obesity effects muscle glucose utilization during exercise.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to provide the first integrated examination of the interaction between muscle insulin action and exercise-stimulated muscle glucose uptake in obesity from the whole body to the cellular/molecular level.


Eligibility criteria: Inclusion Criteria:

For the exercise studies of leg glucose uptake - "insulin sensitive" group:

* Sedentary, normal weight, premenopausal women.
* Sedentary, age-matched normal weight men.
* Weight stable for two (2) months prior to study.
* Willing to provide written, informed consent.
* For the exercise studies of leg glucose uptake - "insulin resistant" group:

For the exercise studies of leg glucose uptake - "insulin resistant" group:

* Upper body obese (UBO) premenopausal women.
* Age-matched upper body obese (UBO) men.
* Weight stable for two (2) months prior to study.
* Willing to provide written, informed consent.

Exclusion Criteria:

* Age \< 18 or \> 55 years (premenopausal women and age-matched men).
* Use of glucose-lowering agents.
* For female subjects: positive pregnancy test at the time of enrollment or study
* History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
* Active systemic illness or malignancy.
* Symptomatic macrovascular or microvascular disease.

Primary outcomes:
measure: Skeletal muscle glucose uptake
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael D Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03829514: Fenofibrate in Type 2 Diabetes
Official title: Fenofibrate in Type 2 Diabetes- Novel Biomarkers and Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type II
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Diabetic complications affecting the eyes, kidneys, and nerves are difficult to arrest once in progress. Recent evidence that fenofibrate confers a robust yet unexpected benefit in diabetic retinopathy offers an important translational research opportunity. The investigator's global proteomic study will provide new clues as to how fenofibrate protects vulnerable tissues, and will spur discovery of targets for new therapeutic interventions.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes of at least one year's duration; stable glycemic control (no more than 1.0% change in HbA1c in the previous six months, but no limit on HbA1c)
* Triglycerides \>150 mg/dL (in the previous six months)

Exclusion Criteria:

* Previous use of Fenofibrate or other fibrates
* Pregnancy
* Active malignancy
* Recent cardiac event or congestive heart failure
* Active liver disease
* Significant renal impairment (serum creatinine \> 2mg/dl)

Primary outcomes:
measure: Number of Individual Plasma Proteins That Changed From Baseline to End-point Based on Limma T-Test of Protein Abundance as Determined by Proteomic Analysis Via Liquid Chromatography-mass Spectrometry
timeFrame: Six weeks, from baseline visit to study completion visit
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT04181814: Gastric Ultrasound for Preoperative Assessment of Gastric Content in Diabetic Patients
Official title: Bedside Gastric Ultrasound for Preoperative Assessment of Gastric Content in Diabetic Patients Following ASA Fasting Guidelines
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aspiration Pneumonia
Gastric Volume
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-11-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic patients undergoing elective surgery and firmly following ASA fasting guidelines.

Brief summary: ASA fasting guidelines are only applicable to healthy elective surgery patients. Measuring gastric volume now is not easy, and scintigraphy has remained the gold standard technique for many years. This prospective observational study aim to explore the gastric emptying of type 2 diabetic patients.

Detailed description: ASA fasting guidelines are only applicable to healthy elective surgery patients. Measuring gastric volume now is not easy, and scintigraphy has remained the gold standard technique for many years. Ultrasound has progressively emerged as a useful substitute due to its reduced cost and ease of performance.

Using gastric ultrasound measure gastric antrum cross-sectional area to determine whether patients are empty stomach, help anesthesiologists in preoperative evaluation of diabetic patients with the risk of aspiration, so as to guide the anesthesiologist take effective interventions, this prospective observational study aim to explore the gastric emptying of type 2 diabetic patients.

Eligibility criteria: Inclusion Criteria:

1. Ages \>18 years old
2. Diabetes (I or II)
3. Following American Society of Anesthesiologists (ASA) fasting guidelines before surgery
4. Undergoing general anesthesia

Exclusion Criteria:

1. Pregnant
2. Gastric Intestinal Tract (GIT) diseases or surgeries affect gastric emptying
3. Diagnosed with liver dysfunction or renal insufficiency
4. Patients who are unable to cooperate or understand the process

Primary outcomes:
measure: Gastric contents
timeFrame: before anesthesia
measure: Risk factors
timeFrame: before anesthesia
Secondary outcomes:
measure: Perlas grading scale
timeFrame: before anesthesia
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University Medical College
state: Zhejiang
Study officials:
affiliation: The Second Affiliated Hospital of Zhejiang University Medical College
name: Min Yan, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT01614314: Dressing of Tunneled Central Venous Catheter
Official title: Dressing of Tunneled Central Venous Catheter: Preceptorship's Presence or Use of Auto-instructional Guide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Students
Keywords: Preceptorship, simulation, nursing, catheters
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study was to compare the performance of nursing undergraduates in dressing of tunneled central venous access in the simulator, according to the aid of a preceptorship or an auto-instructional guide.

Detailed description: The simulation facilitates the acquisition of knowledge, skills and decision-making required for clinical practice. Mentoring has been employed and valued as pedagogical process qualifier.

The hypothesis of this study was that students who trained with the assistance of a preceptorship had better practical performance when compared to students who used an auto-instructional guide.

Eligibility criteria: Inclusion Criteria:

* students regularly enrolled in the last year of the undergraduate nursing program of a public university

Exclusion Criteria:

* students who did not comply with any of the study's phases
* students who presented performance \> 70% in the pretest

Primary outcomes:
measure: Practical performance in carrying out dressing procedure
timeFrame: 1 day, immediately after the training simulator
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: University of Sao Paulo at College of Nursing
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo at College of Nursing
name: Fernanda TM Braga, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marmol MT, Braga FT, Garbin LM, Moreli L, dos Santos CB, de Carvalho EC. Central catheter dressing in a simulator: the effects of tutor's assistance or self-learning tutorial. Rev Lat Am Enfermagem. 2012 Nov-Dec;20(6):1134-41. doi: 10.1590/s0104-11692012000600016. English, Portuguese, Spanish.
Clinical trial NCT04258514: The Effect of Virtual Reality on Anxiety During Vasectomy
Official title: The Effect of Virtual Reality on Anxiety During Vasectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vasectomy
Virtual Reality
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 0
Sex: MALE
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of the study is to determine if the use of Virtual Reality (VR) goggles reduces the degree of anxiety patients experience during vasectomy procedures. The eligibility criteria include a.) appropriate age (19-100 years); b.) undergoing elective vasectomy procedure for purpose of desired sterility; c.) acceptance of wearing goggles; d) able to provide informed consent.There will be two groups, Group A will wear VR goggles and Group B will not. Evaluations will be done by survey to include questions regarding the level of anxiety experienced during the procedure, along with satisfaction scores of the experience.

Detailed description: 1. The aim of the study is to evaluate the efficacy of virtual reality goggles (VRG) for improving the patient's experience during vasectomy procedure.
2. The secondary aim is to determine if VRG reduces the level of anxiety experienced during vasectomy procedure.

VR is an immersive, multisensory experience in a three-dimensional environment designed to replicate a real world. It has been shown in multiple studies to decrease acute and chronic pain in a variety of clinical settings. The mechanism is due to distraction by activating visual, auditory and proprioceptive senses. One example of this is a report by G. Pooja et. al. where in VR goggles reduced pain and medication use during orthopedic procedures (1). Another study found decrease in pain in medically treated patients (n=50 patients in 2 groups) after a 15 minute VR viewing on pain reduction compared to 2 -D viewing (2).

Eligibility criteria: Inclusion Criteria:

1. Appropriate age range (19-100 years)
2. Undergoing elective vasectomy procedure in the urology clinic
3. Willing to sign consent to participate in the study

Exclusion Criteria:

1. Visually impaired (blind)
2. 18 years of age or younger
3. Subjects under the influence of medications will not be approached regarding study participation.

Primary outcomes:
measure: Procedure anxiety
timeFrame: during vasectomy Procedure
measure: Procedure anxiety
timeFrame: 10 minutes prior to procedure start
measure: Procedure anxiety
timeFrame: 10 minutes after procedure ends
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Nebraska
name: Christopher M Deibert, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: