louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02318615: Immediate Axillary Plasty With a Pedicled Muscle Flap for Breast Cancer Related Lymphedema Prevention
Official title: The Efficacy and Safety of Immediate Axillary Plasty With Pedicled Partial Latissimus Dorsi Muscle Flap for Lymphedema Prevention in Breast Cancer Patients Who Undergoing Axillary Dissection: a Prospective, Corhort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphedema
Breast Neoplasm
Keywords: Breast Neoplasm
Lymphedema
Autologous flap
lattismus dorsi flap
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2014-12-17
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this comparable cohort study is to evaluate the efficacy and safety of immediate axillary plasty with pedicled partial Latissimus Dorsi muscle flap for lymphedema prevention in breast cancer patients who are undergoing axillary dissection.

Detailed description: Upper limb lymphedema is the main complication of axillary dissection. It is estimated that as many as 50% of patients undergoing lymph node dissection go on to develop lymphedema, with significantly decreased quality of life with frequent infections, decreased range of motion, and a cosmetic deformity. The treatment of lymphedema was be frustrated by technical difficulties and gave rise to a heavy budget burden. Some retrospective studies revealed that immediate and delayed breast reconstruction with lattismus dorsi flap brought unexpected relief to the upper limb lymphedema. The current study was composed to assess whether transferring a pedicled partial latissimus dorsi muscle flap to the axilla would prevent the occurrence of post-mastectomy lymphedema.

This prospectively designed cohort study have two parallel arms. Patients undergoing axillary dissection would be recruited to one of the two groups, according their own preference.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing axillary lymph node dissection

Exclusion Criteria:

* Prior iplateral upper limb edema
* Plan for breast or axillary reconstruction
* The thoracodorsal vessel damage
* Muscle flap volume too low

Primary outcomes:
measure: Incidence of lymphedema and/or severity of lymphedema
timeFrame: Up to 3 years
Secondary outcomes:
measure: Shoulder Mobility
timeFrame: up to 3 years
measure: Postoperation seroma
timeFrame: up to one month
measure: Acute Upper limb thrombosis
timeFrame: Up to one month
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital
name: Houpu Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04087915: Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With High Risk Coronary Artery Disease (FORWARD)
Official title: A Perspective, Cohort Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab is Used in Combination With Statin Therapy In Patients With High Risk Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dyslipidemia
High Risk Coronary Artery Disease
Keywords: High cholesterol
Treatment for high cholesterol
Lowering cholesterol
Lowering high cholesterol
Hypercholesterolemia
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with high risk coronary artery disease

Brief summary: The primary objective was to evaluate the effect of treatment with evolocumab on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with high risk coronary artery disease.


Eligibility criteria: Inclusion Criteria:

* Male or female ≥ 18 years of age
* Coronary artery disease at high risk (Syntax Score ≥ 33)
* Patients had to have a fasting LDL cholesterol level of 1.4 mmol per liter while they had been taken an optimized regimen of lipid-lowering therapy for at least 4 weeks, which was defined as preferably a high intensity statin but must have been at least atorvastatin at a dose of 20 mg daily or its equivalent, with or without ezetimibe.

Exclusion Criteria:

* New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction \< 30%
* Uncontrolled hypertension
* Uncontrolled or recurrent ventricular tachycardia
* Untreated hyperthyroidism or hypothyroidism
* Homozygous familial hypercholesterolemia
* LDL or plasma apheresis

Primary outcomes:
measure: Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE)
timeFrame: 1 year
Secondary outcomes:
measure: Reduction in LDL-C
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Yujie Zhou, PhD,MD
role: STUDY_CHAIR
References:
Clinical trial NCT06806215: The Relationship Between Academic Burnout and Psychological Resilience
Official title: The Relationship Between Academic Burnout and Psychological Resilience Among Undergraduates Medical Students, Faculty of Medicine, Mansoura University
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burnout
Resilience
Coping
Keywords: burnout
resilience
coping
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 471
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: undergarduate medical students at Mansoura Faculty of Medicine

Brief summary: A cross sectional study of prevalence and correlates of burnout and resilience among indergraduate medical students

Detailed description: A questionnaire based cross sectional study of The relationship between academic burnout and psychological resilience among undergraduates medical students, Faculty of Medicine, Mansoura University

Eligibility criteria: Inclusion Criteria:

- undergarduate medical students at Mansoura Faculty of Medicine

Exclusion Criteria:

* graduate students and interns

Primary outcomes:
measure: burnout ,resilience
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine Alexandria University
Study officials:
affiliation: University of Alexandria
name: soha Rashed
role: STUDY_DIRECTOR
References:
Clinical trial NCT00336115: The Safety and Immunogenicity of Acellular Pertussis Vaccine in Bone Marrow Transplant Recipients
Official title: Safety and Immunogenicity of Adult Formulation Tetanus and Diphtheria Toxoids Adsorbed Combined With Acellular Pertussis (Tdap) Vaccine Following Blood and Morrow Transplantation in Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pertussis
Keywords: pertussis
bone marrow transplant
Lead sponsor: Queen Elizabeth II Health Sciences Centre
Sponsor class: OTHER
First posted: 2006-06-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if pertussis (whooping cough) vaccine is safe and produces an appropriate immune response against pertussis in blood and marrow transplant patients.


Eligibility criteria: Inclusion Criteria:

* Aged 18-64
* BMT at the QEII Health Sciences Centre
* BMT within last 12 months
* Able to read and write English language
* Able to give consent

Exclusion Criteria:

* Active infection
* Active GVHD
* Recent IVIG
* Allergy to components of vaccine
* Diphtheria or tetanus vaccination within 18 months

Primary outcomes:
measure: Safety of the vaccine
timeFrame: 28 days post-dose
Secondary outcomes:
measure: Immunogenicity of vaccine
timeFrame: 60 days post-dose
Other outcomes:
Locations:
Study officials:
affiliation: Dalhousie University Medical School
name: Monique L MacFarlane Conrad, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen Elizabeth II Health Sciences Centre
name: Shelly McNeil, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00000515: Randomized Trial of Dietary Intervention Therapy in Obese Hypertensives (DITOH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
Obesity
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 1999-10-28
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine the effects on blood pressure of dietary intervention, restricting caloric intake to 600 calories per day for 16 weeks compared to a control diet of 1200 calories per day in obese hypertensives. Secondary aims included a study of psychological characteristics at baseline and during the weight loss and maintenance phases of the study.

Detailed description: BACKGROUND:

Hypertension is a highly prevalent disorder contributing to a large proportion of cardiovascular morbidity and mortality in the United States. Although drug therapy of elevated blood pressure can reduce the risks of cardiovascular morbidity and mortality, such therapy constitutes significant expense for individuals over long periods of time as well as large national expenditures. In addition, the side effects of drug therapy may be significant. DITOH would provide much needed information concerning the effects of various means of weight reduction on blood pressure as possible definitive therapy for hypertension or as an approach which could be combined with reduced drug dosages.

DESIGN NARRATIVE:

Randomized. After three weeks on a control diet, subjects were randomized to the Protein Sparing Modified Fast Diet which provided 600 calories per day (1.5 grams per kilogram of ideal body weight of high quality protein plus 19 grams of fat) or to a 1200 calorie per day Balanced Deficit Diet. After 16 weeks in the weight-loss phase, subjects entered the maintenance program for 20 weeks. Both diets were supplemented with vitamins, minerals, and fluids. The Protein Sparing Modified Fast Diet was supplemented with 5 grams of salt given as bouillon to equal the salt intake of the Balanced Deficit Diet. Patients were followed for 24 months after the end of the weight loss phase. The primary endpoint was change in diastolic blood pressure. Individuals who continued to have diastolic pressures above 104 mm Hg following the initial 16 week treatment period were treated with antihypertensive drugs.

The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

Eligibility criteria: Men and women, ages 25 to 55. Subjects were obese, weighing between 130 and 210 percent of ideal body weight. Subjects had diastolic blood pressures between 90 and 105 mm Hg and were not on antihypertensive medications.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: George Blackburn
References:
Clinical trial NCT04146415: Diagnosis of Cardiac Amyloidosis With 99mTc-PYP; Comparison Between Planar Imaging, SPECT/CT and Cardiac-dedicated CZT Camera
Official title: Diagnosis of Cardiac Amyloidosis With 99mTc-PYP; Comparison Between Planar Imaging, SPECT/CT and Cardiac-dedicated CZT Camera
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Amyloidosis
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-10-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 1. Patients will undergo clinical and laboratory assessment, as well as imaging tests, at the discretion of the attending cardiologist and will be referred at their discretion to perform cardiac mapping using 99mTc-PYP.
2. On the day of the examination, the examiner will be admitted to the Office of Nuclear Medicine and will be admitted to administrative. Before conducting the test, the subject will undergo a brief interview by a physician, receive an explanation of the study and, if agreed, sign an agreement to perform a further examination on the CZT camera.
3. The patient will, as is customary, be installed on Vanflon 22 G periphery, through which a 15 millikiric (mCi) of


Eligibility criteria: Inclusion Criteria:

A. Patients undergoing "cardiac amyloidosis clinic" at Tel Aviv Medical Center and there is a clinical suspicion of having cardiac amyloidosis.

B. Patients who performed will be referred for mapping using 99mTc-PYP and sign a consent form to take another photograph, under the cardiac-dedicated CZT camera

Exclusion Criteria:

1.None

Primary outcomes:
measure: Patients who preformed mTc99-PYP for cardiac amyloidosis imaging.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01183715: A Single Dose Study Of PF-05161704 In Healthy Volunteers
Official title: A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-05161704 After Administration Of Single Escalating Oral Doses Under Fed And Fasted Conditions In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: Single Ascending Dose
Phase 1
Safety and Tolerability
PK
Healthy Subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-08-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-05161704 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female (non child-bearing potential) subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
* History or evidence of habitual use of tobacco or nicotine containing products within 3 months of Screening or positive cotinine test at screening or Day 0 of period one

Primary outcomes:
measure: Safety and tolerability of escalating single oral doses of PF-05161704 in healthy subjects
timeFrame: 1 month
measure: Single dose pharmacokinetics of PF-05161704 and its metabolite PF-05200145
timeFrame: 1 month
Secondary outcomes:
measure: Preliminary pharmacodynamics of PF-05161704
timeFrame: 1 month
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05316415: The Effects of Music on the Anxiety and Sleep Quality of Pregnant Women on Bed Rest for a High-risk Pregnancy
Official title: The Effects of Music on the Anxiety and Sleep Quality of Pregnant Women on Bed Rest for a High-risk Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy, High Risk
Anxiety State
Sleep Quality
Keywords: Anxiety
bed rest
high-risk pregnancy
music
sleep quality
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to identify the effects of music on the anxiety and sleep quality of women with high-risk pregnancy having bed rest in the hospital in Turkey.

This randomized-controlled study involved 80 control and 80 experimental group with a high-risk pregnant woman .

Detailed description: The literature review indicates a limited number of studies on the effects of music in eliminating the anxiety and sleep problems in women with a high-risk pregnancy having bed rest in the hospital; the existing studies were found to be mainly about anxiety. The purpose of this study is to identify the effects of music on the anxiety and sleep quality of women with a high-risk pregnancy having bed rest in the hospital.

This study adopted a pretest-posttest randomized controlled study involved 80 control and 80 experimental group with a high-risk pregnant woman . The women in the experimental group listened to Acemaşiran music for 40 minutes in successive three days and two times a day.

Eligibility criteria: Inclusion Criteria:

* Agreeing to participate in the study
* Knowing Turkish and being literate
* Having been hospitalized for bed rest for at least 5 days.
* Having a gestational age of 28 to 36 weeks
* Being hospitalized due to at least one of the diagnoses including hypertensive diseases, diabetes mellitus, preterm labor, placenta previa, cervical insufficiency, or premature rupture of the membrane

Exclusion Criteria:

* Fetal congenital anomalies
* Having a hearing impairment

Primary outcomes:
measure: State-trait Anxiety Inventory
timeFrame: Two hours after the last listening session, the participants were administered the State-trait anxiety inventory to measure
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: . Two hours after the last listening session, the participants were administered the Pittsburg Sleep Quality Index to measure their sleep quality.
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University Balcalı Hospital
state: Saricam
Study officials:
References:
Clinical trial NCT00267215: Efficacy and Safety of Lumiracoxib
Official title: A One-week Multicenter, Multiple-dose, Randomized, Double-blind, Double-dummy, Parallel-group Comparison of the Analgesic Efficacy and Safety of Lumiracoxib (COX189), Celecoxib, and Placebo in the Treatment of Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Lumiracoxib
osteoarthritis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-12-20
Enrollment: 330
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial assessed the safety and efficacy of a single dose of lumiracoxib 400 mg compared to placebo and to a single dose of celecoxib 200mg. It also assessed safety and efficacy of 400mg lumiracoxib administered once a day for 7 days compared to placebo and to 200 mg celecoxib twice daily.


Eligibility criteria: Inclusion criteria:

* Osteoarthritis of the knee
* Pain intensity at baseline of at least 50mm on a 100mm visual analog scale

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Assess the short-term (3-5 hours) analgesic efficacy of COX189, 400mg administered once a day for 7 days, compared to placebo and to 200mg celecoxib bid
Secondary outcomes:
measure: Assess the safety and tolerability profile of COX189 in comparison to placebo and celecoxib
Other outcomes:
Locations:
city: Nuernberg
country: Germany
facility: Novartis
Study officials:
References:
citation: Wittenberg RH, Schell E, Krehan G, Maeumbaed R, Runge H, Schluter P, Fashola TO, Thurston HJ, Burger KJ, Trechsel U. First-dose analgesic effect of the cyclo-oxygenase-2 selective inhibitor lumiracoxib in osteoarthritis of the knee: a randomized, double-blind, placebo-controlled comparison with celecoxib [NCT00267215]. Arthritis Res Ther. 2006;8(2):R35. doi: 10.1186/ar1854. Epub 2006 Jan 16.
Clinical trial NCT06062615: Robotic Assisted TKA
Official title: Randomized Pilot Study Investigating Early Functional Outcomes With the Use of Robotic Assisted Versus Conventional Total Knee Arthroplasty"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Replacement
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As an intraoperative tool, a modern robotic total knee arthroplasty (TKA) system should be able to identify a patient's native femoral and tibial anatomy, as well as, assess ligament tension and gap balance. The surgeon in real time is then able to develop and execute a patient specific plan in terms of component size, alignment and rotation. In our institution we have begun to use, the OMNIBotics Knee system (Corin), which utilizes an active motorized knee spacer, BalanceBot, to objectively measure ligament tension and gap balance after the tibia has been cut and its alignment confirmed. This information is then processed through the OMNIbotics computer algorithm to appropriately size, align, and rotate the femur component to balance the flexion and extension gaps. The purpose of this study is to perform a randomized pilot study looking for an effect on early functional outcomes comparing robotic assisted TKA (RATKA) versus conventional TKA technique.


Eligibility criteria: Inclusion Criteria:

* All unilateral primary knee arthroplasties performed by the investigator participating in this study will be eligible for inclusion
* Diagnosis of primary osteoarthritis

Exclusion Criteria:

* Revision surgery
* Bilateral knee surgery
* Age \<18 or \>80
* BMI \>40
* Baseline lower extremity strength less than 5/5
* History of chronic narcotic use, defined as more than 5mg of oxycodone q4 hours
* Functionally limiting spine disease
* Other functionally limiting lower extremity disorder (i.e. symptomatic ipsilateral hip disease)
* Patients who cannot perform the baseline functional tests
* Allergy/contraindication to protocol medications
* Post-traumatic arthritis
* Inflammatory arthritis
* Pregnancy
* Prisoners
* Patients receiving care as a result of a worker's compensable injury
* General anesthesia

Primary outcomes:
measure: early functional outcomes #1
timeFrame: 6 months
measure: Early functional outcomes #2
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
affiliation: Rothman Orthopaedic Institute
name: Matt Austin, MD
role: PRINCIPAL_INVESTIGATOR
References: