louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04130009: Total Knee Arthroplasty With and Without Tourniquet: Comparative Study
Official title: Total Knee Arthroplasty With and Without Tourniquet: Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: Thigh pain
Total knee Arthroplasty
Tourniquet
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 70
Sex: ALL
Minimum age (years): 48
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is comparative study between two groups one treated by Total knee with tourniquet and other group without tourniquet
Primary purpose: TREATMENT

Brief summary: Tourniquet use during total knee arthroplasty (TKA) improves visibility and reduces intraoperative blood loss. However, tourniquet use may also have a negative impact on early recovery of muscle strength and lower extremity function after TKA.Seventy Patients are involved in this study and were divided into two groups; Group A (35) patients were treated with TKA with pneumatic thigh tourniquet. Group B (35) patients were treated with TKA without tourniquet. All patients were suffering from severe knee osteoarthritis and they failed to respond to conservative treatment so they are candidates for primary TKA. The two groups are matched related to age and gender. Selection of patients into two groups done randomly with regard of odd number for group A and even number for group B

Detailed description: This study started on March 2016 and ends on October 2018. Seventy Patients are involved in this study and were divided into two groups; Group A (35) patients were treated with TKA with pneumatic thigh tourniquet. Group B (35) patients were treated with TKA without tourniquet. All patients were suffering from severe knee osteoarthritis and they failed to respond to conservative treatment so they are candidates for primary TKA. The two groups are matched related to age and gender. Selection of patients into two groups done randomly with regard of odd number for group A and even number for group B. All patients were followed for a period of two weeks until removal of skin sutures for the following parameters:

Amount of blood transfusion done at and after surgery. Amount of blood drained postoperatively through suction drain. Occurrence of postoperative wound hematoma. VAS (Visual analogue score) for thigh pain at 1st day and (2) weeks postoperatively.

Clinical DVT.

Eligibility criteria: Inclusion Criteria:

* patients were suffering from severe knee osteoarthritis and they failed to respond to conservative treatment

Exclusion Criteria:

* Hb less than 12.
* D.M.,Blood dyscrasia.
* Any evidence of infection by screening test ESR and CRP. ,
* BMI more than 30.

Primary outcomes:
measure: Visual Analogue score for thigh pain
timeFrame: The VAS for thigh pain was measured in the day 14 after operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03623009: Gender Stigma Consciousness and Surgical Training
Official title: The Effect of Gender-stigma Consciousness on General Surgery Trainees' Experiences and Skill Performance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gender Issues
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: University of Washington
First posted: 2018-08-09
Enrollment: 85
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Previous investigations have focused on challenges that surgeons face once they have entered into practice. We have yet to explore difficulties in the training environment, and whether these have an effect on professional development. In this study, we investigate how certain environmental factors can affect skill acquisition for the resident surgeon. Our trial tests whether psychosocial constructs affect task-performance. This study is a multi-center endeavor with the University of North Carolina-Chapel Hill, the University of Washington, and UPMC. Over an 12 month period, residents will be asked to complete surveys and a laparoscopic skills assessment, which will be administered after residents are randomized to an intervention or control arm. The intervention arm will be asked to read an article that is meant to trigger psychosocial constructs that we hypothesize will affect skill performance. The control arm will receive a neutral article prior to completing the laparoscopic skills assessment.


Eligibility criteria: Inclusion Criteria: Categorical General surgery residents who completed undergraduate medical education in the United States

Exclusion Criteria: Residents who have completed graduate medical education training in a subspecialty prior to their general surgery residency.

Primary outcomes:
measure: Score on laparoscopic skills assessment
timeFrame: 12 months
Secondary outcomes:
measure: Changes in psychosocial constructs
timeFrame: 12 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Sara P Myers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Myers SP, Dasari M, Brown JB, Lumpkin ST, Neal MD, Abebe KZ, Chaumont N, Downs-Canner SM, Flanagan MR, Lee KK, Rosengart MR. Effects of Gender Bias and Stereotypes in Surgical Training: A Randomized Clinical Trial. JAMA Surg. 2020 Jul 1;155(7):552-560. doi: 10.1001/jamasurg.2020.1127.
Clinical trial NCT00893009: The Effect on Small Airways of Addition of Theophylline as Inducer of Histone Deacilase Activity for Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Treated With Inhaled Steroids and Long Acting Beta Agonists
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Keywords: Forced expiratory volume in one second
Inspiratory capacity
endurance time
residual volume
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-05-05
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Chronic obstructive pulmonary disease (COPD) is a chronic progressive respiratory disorder causing disability with an increasing burden to the patient, his family and to the health services. Treatment of COPD patients depends on the stage of the disease. COPD responds poorly to corticosteroids, in spite of inflammation is a major component in its pathogenesis. A major barrier to therapy of COPD is resistance to the anti-inflammatory effects of corticosteroids. The molecular mechanisms for this corticosteroid resistance are now being elucidated, particularly as the molecular basis for the anti-inflammatory effects of corticosteroids is better understood (12). An important mechanism of corticosteroid resistance in COPD, which is also linked to amplification of the inflammatory process, is a reduction in the critical nuclear enzyme histone deacetylase (HDAC)2 . Since the major changes are at the level of small airways. We will examine the effect of addition of theophylline product to stable COPD patients treated with combined inhaler of inhaled corticosteroids.


Eligibility criteria: Inclusion Criteria:

* stable stage II and III (GOLD) COPD, diagnosed 2 years ago and up

Exclusion Criteria:

* Heart failure Malignancy Immune suppressed

Primary outcomes:
measure: Air trapping
timeFrame: 1 year
Secondary outcomes:
measure: endurance time
timeFrame: 1 year
Other outcomes:
Locations:
city: Beer Yaakov
country: Israel
facility: Pulmonar Institute, Assaf Harofeh Medical Center
Study officials:
References:
Clinical trial NCT00256009: Treatment of Late Abortion: Evacuatio Uteri or Conservative Treatment
Official title: Evacuatio Uteri or Conservtive Treatment After Late Abortion. A Randomize Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Abortion, Spontaneous
Abortion, Induced
Keywords: Late abortion
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2005-11-21
Enrollment: 200
Sex: FEMALE
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: A randomize trial: expectation or evacuatio uteri for the treatment after late abortion

Detailed description: A randomize trial adressing 200 women consecutively recruited from clinical practice at Rigshospitalet.Expectation: administration of 800 microgram Cytotec half an hour after delivery. Surgery: Evacuation of the uterus

Eligibility criteria: Inclusion Criteria:

abortion at gestational age (ultrasound) 14+0 - 20+0

Exclusion Criteria:

Allergy to cytotec

Primary outcomes:
measure: Side-effect
measure: Complication
Secondary outcomes:
measure: Quality of life
Other outcomes:
Locations:
Study officials:
affiliation: Rigshospitalet, Denmark
name: Lars Alling Møller, MD phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00213109: Open Trial of Miglitol in Type 1 Diabetic Patients With Insulin Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes Mellitus
Keywords: alpha-glucosidase inhibitor,Insulin
Lead sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2005-09-21
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is evaluate the clinical efficacy and safety of Miglitol in patients with Type1 Diabetes Mellitus treated with insulin.


Eligibility criteria: Inclusion Criteria:

* Type1 Diabetes
* Criteria of postprandial glucose and HbA1c are met

Exclusion Criteria:

* Type2 Diabetes
* Patients with antidiabetic drugs
* The other exclusion criteria are met

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chiba
country: Japan
city: Fukuoka
country: Japan
city: Gifu
country: Japan
city: Ibaraki
country: Japan
city: Kanagawa
country: Japan
city: Kumamoto
country: Japan
city: Oita
country: Japan
Study officials:
affiliation: Sanwa Kagaku Kenkyusho Co., Ltd.
name: Clinical Promotion Group
role: STUDY_DIRECTOR
References:
Clinical trial NCT06886009: Spesolimab Post-marketing Surveillance in Korean Patients With Flares With Generalized Pustular Psoriasis
Official title: A Regulatory Requirement Non-interventional Study to Monitor the Safety and Effectiveness of Spesolimab in Korean Patients With Flares With Generalized Pustular Psoriasis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Generalized Pustular Psoriasis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2025-03-20
Enrollment: 21
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with generalized pustular psoriasis (GPP) in Korea

Brief summary: The primary and secondary objectives are to respectively monitor the safety and effectiveness of Spesolimab IV in Korean patients with flares with generalized pustular psoriasis (GPP) in a routine medical practice.


Eligibility criteria: Inclusion criteria:

* Patients starting Spesolimab IV for the first time in accordance with the approved label in Korea (complete enumeration for the first 2 years after product launch)
* Patients with generalized pustular psoriasis (GPP) flare
* Age \>/=19 years at enrolment
* Patients who have signed the data release consent form

Exclusion criteria:

* Patients with Severe or life-threatening hypersensitivity to Spesolimab or to any of the excipients
* Patients with clinically important active infections (e.g. active tuberculosis)

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to 24 weeks
measure: Incidence of adverse drug reactions (ADRs)
timeFrame: Up to 24 weeks
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 24 weeks
measure: Incidence of serious adverse drug reactions (SADRs)
timeFrame: Up to 24 weeks
measure: Incidence of unexpected adverse drug reactions
timeFrame: Up to 24 weeks
measure: Incidence of adverse events of special interest (AESIs)
timeFrame: Up to 24 weeks
measure: Incidence of adverse events leading to temporary or permanent discontinuation
timeFrame: Up to 24 weeks
measure: Incidence of adverse events leading to death
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Physician's Global Assessment for Generalized Pustular Psoriasis (GPPGA) pustulation sub-score of 0 indicating no visible pustules at Week 1
timeFrame: At Week 1
measure: A GPPGA pustulation sub-score of 0 indicating no visible pustules at Week 4
timeFrame: At Week 4
measure: A GPPGA score of 0 or 1 at Week 1
timeFrame: At Week 1
measure: A GPPGA score of 0 or 1 at Week 4
timeFrame: At Week 4
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT06372509: A Proteomic Analysis for Understanding the Link Between Migraine and Cardiovascular Disease
Official title: A Proteomic Analysis for Understanding the Link Between Migraine and Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Migraine
Cardiovascular Diseases
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
Collaborators: name: IRCCS Policlinico S. Donato
First posted: 2024-04-18
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients admitted for non coronary disease, will follow their clinical pathway. They will be classified into symptomatic for migraine with aura (N=45) and free from migraine (N=45) and will be enrolled in the study.

Brief summary: This is a multicenter, prospective observational study. Will be collecting data from 90 consecutive patients (aged 25- 60 years ) with and without migraine admitted at our Hospital. Primary aim of the study will be to assess the correlation between migraine and proteomic profiling of plasma and their possible correlation with known cardio and cerebrovascular disease and Cardiovascular (CV) risk factors.

Detailed description: Ninety consecutive patients hospitalized for noncoronary artery disease will follow their clinical course. They will be classified into symptomatic for migraine with aura (N=45) and migraine free (N=45) and will be enrolled in the study. Patients will be screened for migraine characteristics and a comprehensive clinical analysis, including sex-related cardiovascular risk factors, will be collected. To achieve the study objective, blood will be drawn to do targeted proteomic evaluation of proteins relevant to Cardiovascular disease (CVD), inflammation, immune response, and neurological disorders, in order to compare the profile of migraine patients with that obtained in patients without migraine.

Eligibility criteria: Inclusion Criteria:

* Age \>25 years and \> 60 years
* Signed patient informed consent form (ICF)
* Non-coronary disease

Exclusion Criteria:

* Age \< 25 years and \> 60 years
* Acute myocardial infarction (MI)
* Chronic kidney disease: glomerular filtration rate (GFR) \< 30 ml/min
* Severe mitral or aortic valvular disease
* Acute heart failure
* Reduced left ventricular (LV) function (Ejection Fraction \< 35%)
* Atrial Fibrillation

Primary outcomes:
measure: Correlation between migraine and proteomic profiling of plasma
timeFrame: October 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
state: Milan
Study officials:
References:
Clinical trial NCT00109109: A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma (0683-004)
Official title: Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-04-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purposes of this study are:

* To determine the maximum tolerated dose (MTD) of SAHA administered every 12 hours for 14 consecutive days followed by 7 days of rest during the first two cycles (i.e., first 6 weeks) in patients with advanced multiple myeloma;
* To assess the safety and overall response rate to SAHA in patients with advanced multiple myeloma.


Eligibility criteria: Inclusion Criteria:

* Adult patients with refractory or relapsed multiple myeloma, ECOG performance status 0-2 (ECOG)
* Adequate bone marrow reserve
* Adequate hepatic and renal function
* Ability to swallow capsules
* 3 weeks or more from prior chemotherapy and have recovered from prior toxicities

Exclusion Criteria:

* Patients who plan to go for bone marrow transplant within 4 weeks of start of treatment
* Patients with prior treatment with other investigational agents with a similar anti-tumor mechanism
* Patients with other active/uncontrolled clinically significant illnesses
* Pregnant or nursing female patients

Primary outcomes:
measure: PHASE I: Maximum tolerated dose (MTD) of vorinostat in patients with advanced multiple myeloma.
measure: PHASE II: Safety and overall response rate to SAHA in patients with advanced multiple myeloma.
Secondary outcomes:
measure: 1) Anti-tumor activity in patients with advanced multiple myeloma; 2) Biological effects of SAHA in peripheral mononuclear cells and bone marrow plasma cells; 3) Correlation of biological effects of SAHA with serum drug concentration.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Richardson P, Mitsiades C, Colson K, Reilly E, McBride L, Chiao J, Sun L, Ricker J, Rizvi S, Oerth C, Atkins B, Fearen I, Anderson K, Siegel D. Phase I trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) in patients with advanced multiple myeloma. Leuk Lymphoma. 2008 Mar;49(3):502-7. doi: 10.1080/10428190701817258.
Clinical trial NCT06632509: BD SiteRite(TM) 9 Ultrasound System - Clinical Study
Official title: BD SiteRite(TM) 9 Ultrasound System - Clinical Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: BD SiteRite 9 for VAD Insertion
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2024-10-09
Enrollment: 149
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects are defined as patients who need to receive insertion of a vascular access devices (VAD) as part of their medical treatment.

Brief summary: This post-market study is being conducted to generate safety and performance data on the SiteRite 9 System. The data will be utilized to support regional registrations (for example, EU MDR), and document any unforeseen residual risks.

Detailed description: This is an observational post-market, human subject study to evaluate the safety and performance of the SiteRite 9 System. Subjects will be recruited for participation based on need for Vascular Access Device (VAD) placement in a hospital setting.

Enrolled subjects will go through ultrasound-guided Vascular Access Device (USGVAD) placement as part of their clinical care. USGVAD is defined as a procedure in which an ultrasound machine is used to assist a qualified health care provider with IV cannulation from skin puncture through venipuncture via direct visualization on the ultrasound machine in real time.

Eligibility criteria: Inclusion Criteria

* Age 1 years, or older
* A patient who is a candidate for an ultrasound-guided VAD placement procedure using SiteRite 9 System as assessed per their clinician(s)
* Able and willing to provide informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the subject

Exclusion Criteria:

* Any patient in whom ultrasound procedure might interfere with medical care or create undue hardship
* Known, or suspected, allergy to materials contained in the SiteRite 9 System or accessories that may come in contact with the patient
* Localized skin, tissue, or other clinical factors that would prevent completion of the ultrasound procedure
* Previous medical history that would prevent completion of the ultrasound procedure

Primary outcomes:
measure: Primary Performance: To provide visualization of the target vessel in which to insert the chosen vascular access device.
timeFrame: During the procedure
measure: Primary Performance: To have successful vascular access either by cannulation or blood return.
timeFrame: During the procedure
measure: Primary Safety: To determine the incidence of device related adverse events, experienced by patient or user, when using the BD SiteRiteTM 9 Ultrasound System.
timeFrame: During the procedure and 15 minutes after the procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06762509: The Clinical Study of Botulinum Toxin Type A Injection in the Treatment of Wilson Disease
Official title: The Clinical Study of Botulinum Toxin Type A Injection in the Treatment of Wilson Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wilson Disease
Keywords: botulinum toxin type A
wilson disease
Lead sponsor: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE

Brief summary: In order to expand the treatment of Wilson disease and improve the quality of life of patients with Wilson's disease, the clinical effect of botulinum toxin type A injection on Wilson's disease was discussed.


Eligibility criteria: Inclusion Criteria：1.Conform to the diagnosis of "2012 European Liver Study Guidelines for Diagnosis and Treatment of hepatolenticular degeneration". 2. Aged from 15 to 65 years.

Exclusion Criteria:Non-Wilson's disease

Primary outcomes:
measure: Unified Dystonia Rating Scale(UDRS)
timeFrame: 4 weeks
measure: Unified Wilson's Disease Rating Scale(UWDRS)
timeFrame: 4 weeks
measure: Numeric Rating Scales(NRS)
timeFrame: 4 weeks
measure: Activity of Daily Living Scale(ADL)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, #117 Meishan Street, Shushan District Hefei 230037, China
Study officials:
References: