louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01593527: Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease
Official title: A Randomized Double-blind Active-controlled Trial of Canakinumab Versus Triamcinolone Acetonide on Reducing the Proportion of Patients With Any New Gouty Arthritis Flare(s) in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Acute Gouty Arthritis
Keywords: Frequent flares
Frequent attacks
gout
gouty arthritis
Chronic kidney disease
renal impairment
Anti-interleukin-1β monoclonal antibody
anti-inflammatory therapy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-05-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to confirm the efficacy and safety results obtained in a chronic kidney disease (CKD) subgroup of patients participating in Phase III studies in a larger, independent patient population with difficult to treat gouty arthritis and moderate to severe CKD (stage 3 - 4).


Eligibility criteria: Inclusion criteria:

* Confirmed diagnosis of gouty arthritis History of ≥ 3 gouty arthritis flares within the previous 12 months
* Confirmed diagnosis/ documented history of chronic kidney disease (CKD) Stages 3or4
* Onset of current acute gouty arthritis flare within 3 days prior to randomization

Exclusion criteria:

* Hemodialysis CKD Stage 5 Organ transplantation
* Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
* Live vaccinations within 3 months prior to randomization Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Proportion of patients experiencing new gouty arthritis flares during 12-week follow-up from dosing
timeFrame: 12 Weeks
Secondary outcomes:
measure: The time to the first new gout flare
timeFrame: 12 Weeks
measure: Score on Visual Analog Scale at 72 hours to measure gouty arthritis pain intensity and resolution
timeFrame: 12 weeks
measure: Number of patients needing rescue medication use during acute gouty arthritis flare(s)
timeFrame: 12 Weeks
measure: Measurement of efficacy using inflammatory markers
timeFrame: 12 Weeks
measure: Time to 50% reduction of baseline pain intensity in the most affected joint
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02136927: Bioavailability Study of SPARC1210 and Reference1210 in Subjects With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2014-05-13
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pharmacokinetic, bioequivalence study


Eligibility criteria: Inclusion Criteria:

* The subject has given written, informed consent and is available for the entire study.
* Histologically or cytologically confirmed diagnosis of breast cancer;
* Locally recurrent or metastatic breast cancer for which taxane-based therapy is a rational treatment option;
* Age 18 years or more

Exclusion Criteria:

* Known hypersensitivity to both the study drugs or its excipients (Cholesteryl sulfate, Caprylic acid, Polyvinylpyrrolidone, Ethanol or Polyethylene glycol);
* Presence of clinically evident active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy;
* Pre-existing clinically significant peripheral neuropathy (Grade 2 or higher according to CTCAE, Version 4.0);
* Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study

Primary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Pre-dose, post-dose up to 3 days
Secondary outcomes:
Other outcomes:
measure: Adverse events
timeFrame: Day 3
Locations:
city: Hyderabad
country: India
facility: SPARC Site 12
state: Andhra Pradesh
city: Hyderabad
country: India
facility: SPARC Site 9
state: Andhra Pradesh
city: New Delhi
country: India
facility: SPARC Site 6
state: Delhi
city: Goraj
country: India
facility: SPARC Site 2
state: Gujarat
city: Cochin
country: India
facility: SPARC Site 8
state: Kerala
city: Mumbai
country: India
facility: SPARC Site 11
state: Maharashtra
city: Nagpur
country: India
facility: SPARC Site 5
state: Maharashtra
city: Nashik
country: India
facility: SPARC Site 4
state: Maharashtra
city: Pune
country: India
facility: SPARC Site 1
state: Maharashtra
city: Pune
country: India
facility: SPARC Site 3
state: Maharashtra
city: Chennai
country: India
facility: SPARC Site 10
state: Tamil Nadu
city: Madurai
country: India
facility: SPARC Site 7
state: Tamil Nadu
Study officials:
References:
Clinical trial NCT00167960: Study Evaluating Vancomycin-Resistant Enterococci in a Hematology Unit
Official title: Effects on the Emergence and Transmission of Vancomycin-Resistant Enterococci After Changes in Antibiotic Use in a Hematology Unit.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gram-Positive Bacterial Infections
Keywords: Bacterial Infections
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: To determine the impact of the restriction of the third and forth generation cephalosporins on the reduction of intestinal colonization or infection with vancomycin-resistant enterococci (VRE) in a surgical intensive care unit (SICU)


Eligibility criteria: Inclusion Criteria:

* All patients admitted to or transferred to the SICU.
* Eligible patients will be patients of either sex, 18 years of age or older who are admitted or transferred to the SICU.
* Provide written informed consent

Exclusion Criteria:

* Patients who have hypersensitivity to penicillin, cephalosporins or beta-lactamase inhibitors.
* Females who are pregnant and breast feeding
* Any underlying conditions or non-infectious diseases that will be ultimately fatal within 48 hours.
* Those who have already been participating other clinical study related with antibiotics.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
city: Ulsan
country: Korea, Republic of
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00291460: Inspiratory Muscle Training in Hypercapnic COPD
Official title: Randomized Controlled Trial of Inspiratory Muscle Training in Patients With Stable Hypercapnic Respiratory Failure Due to COPD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: COPD
Respiratory Failure
Keywords: COPD
respiratory failure
inspiratory muscle training
Lead sponsor: Krankenhaus Kloster Grafschaft
Sponsor class: OTHER
First posted: 2006-02-14
Enrollment: 40
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: The trial intends to investigate, whether inspiratory muscle training in hypercapnic patients improves inspiratory muscle strength, inspiratory muscle endurance and endurance to walk within six minutes.

Detailed description: Inspiratory muscle training is known to improve inspiratory muscle strength, inspiratory muscle endurance and walking distance within six minutes in patients with neuromuscular and thoraco-restrictive disease as well as in patients with COPD. Studies have only been conducted in patients without established respiratory failure. COPD patients with respiratory failure though are characterized by higher work rates of the inspiratory muscles and higher esophageal pressure swings compared to non-hypercapnic patients indication a discrepancy between muscle load and muscle capabilities. Therefore we hypothesize that for these patients training of their inspiratory muscles will be of benefit in terms of improvement of muscular and whole body endurance.

During this investigation inspiratory muscle training will be applied in a randomized controlled fashion in 40 patients over a period of four weeks parallel to physical rehabilitation.

Eligibility criteria: Inclusion Criteria:

* COPD with FEV1/FVC \< 70 %
* age \> 18
* stable disease
* able to walk
* carbon dioxide \>= 48 mmHg

Exclusion Criteria:

* ejection fraction of the heart \< 40 %
* active psychiatric disease
* bronchial hyperresponsiveness according to ATS criteria
* pregnancy
* renal insufficiency with a creatinine \< 2 mg/dl

Primary outcomes:
measure: inspiratory muscle strength
measure: inspiratory muscle endurance
measure: walking distance with dyspnea score
measure: Carbon dioxide level
Secondary outcomes:
Other outcomes:
Locations:
city: Schmallenberg
country: Germany
facility: Fachkrankenhaus Kloster Grafschaft
Study officials:
affiliation: FKKG
name: Dominic Dellweg, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: FKKG
name: Dieter Koehler, Prof. Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT01431560: Outcomes of Operative Treatment of Unstable Ankle Fracture - Comparison Between Metallic and Biodegradable Implants
Official title: Outcomes of Operative Treatment of Unstable Ankle Fracture - Comparison Between Metallic and Biodegradable Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankle Fracture
Keywords: ankle
metallic
biodegradable
Freedom
Lead sponsor: National Police Hospital
Sponsor class: OTHER_GOV
First posted: 2011-09-09
Enrollment: 109
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes of this study are to compare the outcomes of the biodegradable implants for the fixation of ankle fracture and those of metallic implants, and to assess the problems of the biodegradable implants. Null hypothesis is that the clinical outcomes of biodegradable plate and screws for ankle fracture are not different from those of metallic implants.


Eligibility criteria: Inclusion Criteria:

* skeletally mature subjects (≥16 years old) with unilateral ankle fractures

Exclusion Criteria:

* subjects less than 16 years old,
* subjects not followed up at this hospital,
* multiple injuries,
* bilateral ankle fractures,
* open fractures,
* pathologic fractures,
* concomitant tibial shaft fractures,
* previous history of immobilization due to significant injury or a fracture of either ankle,
* significant peripheral neuropathy,
* soft tissue infection in the region on either injured ankle,
* or inability to complete the study protocol

Primary outcomes:
measure: American Orthopaedic Foot and Ankle Society(AOFAS) score
timeFrame: 3 months, 6 months, 1 year
Secondary outcomes:
measure: Short Musculoskeletal Functional Assessment(SMFA) scale
timeFrame: 3 months, 6 months, 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: National Police Hospital
Study officials:
affiliation: National Police Hospital, Korea, Republic of
name: Jung Ho Noh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06784960: Communication Strategies to Increase HPV Vaccination Intention
Official title: A Cluster Randomized Controlled Trial Testing Communication Strategies to Increase HPV Vaccination Intention: a Survey Experiment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Papilloma Viral Infection
Vaccine Hesitancy
Communication
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 3689
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This research aims to identify communication strategies to improve the uptake of vaccines using an experimental design, focusing on the Human Papillomavirus (HPV) vaccine, which is highly effective in preventing HPV-related cancers. However, low HPV vaccination rates among adults remain a significant public health challenge. Although randomized controlled trials (RCTs) have demonstrated that interventions can increase vaccine uptake in children, few RCTs have been conducted on adults. To address this gap, a multidisciplinary investigative team with expertise in communication, medicine, nursing, and behavior-change intervention research, and a history of extensive collaboration, will conduct a survey experiment on a national sample of over 3,689 adults to identify the most promising theory-based messages to strengthen HPV vaccine intentions.


Eligibility criteria: Inclusion Criteria:

* 18-45 years old

Exclusion Criteria:

* Under 18 and over 45 years old
* Received HPV vaccine or unsure about receipt

Primary outcomes:
measure: Intention to Vaccinate
timeFrame: Immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03934060: Strength Training and ADLs in Childhood Leukemia and Lymphoma Patients
Official title: Effects of a Specific Strength Training Regarding Activities of Daily Living (ADLs) Associated With Movement During Treatment of Leukemia or Non-Hodgkin Lymphoma in Childhood and Adolescence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Cancer
Keywords: exercise
strength training
activities of daily living
childhood cancer
leukemia
Non-Hodgkin lymphoma
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Reduced activity levels and reduced muscular strength could severely impair the activities of daily living (ADLs) in pediatric leukemia and Non-Hodgkin lymphoma patients. Increased muscle strength is associated with improved accomplishment of ADLs and consequently greatest possible normality, autonomy and mobility. Primary outcome of this RCT (n=20/20) is the analysis of effects of a treatment-associated and close to every day life strength training (2-3 times/week) compared to a general exercise program (standard care).


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Acute Leukemia or Non-Hodgkin Lymphoma
* Diagnosed and/or treated at the Kinderklinik München Schwabing, Technische Universität München
* Informed consent as documented by signature

Exclusion Criteria:

* Medical contraindications regarding strength training (e.g. risk of bleeding, ...)
* Contraindications to one of the inclusion criteria mentioned above
* Inability to follow the procedures and understand the intervention and assessments of this study, e.g. due to cognitive impairment, language problems, psychological disorders etc.

Primary outcomes:
measure: Change of score of the Activities Scale for Kids - performance version
timeFrame: Change of the ASK score from baseline to 3 months, change from 3 months to 6 months, change from 6 months to 12 months
Secondary outcomes:
measure: Change of motor performance analyzed with the Motor performance test in Pediatiric Oncology (MOON)
timeFrame: Change of motor performance from baseline to 6 months
measure: Change of level of physical activity
timeFrame: Change of physical activity level from baseline to 3 months, from 3 to 6 months, from 6 to 12 months
measure: Change in performance in a parkour in activities of daily living
timeFrame: Change of score in the parkour from baseline to 6 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Kinderklinik München Schwabing TUM School of Medicine, Department of Pediatrics and Children's Cancer Research Center, Technical University of Munich
state: Bavaria
Study officials:
References:
Clinical trial NCT03420560: A Warmer Temperature Decrease Propofol Injection Pain
Official title: A Warmer Room-temperature at 27-28 Centi-degree Will Decrease Propofol Injection Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Injection Site Irritation
Propofol Syndrome
Temperature Change, Body
Lead sponsor: First People's Hospital of Chenzhou
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients for observation will sent to a warmer operating room,while Patients in controled Group will send to normal setting operating room at about 23 centigrade.
Primary purpose: PREVENTION

Brief summary: Propofol injection pain will be surfed by up to 70-80 percentage by the Patients who induced by propofol. Temperature of Operating room was set to a certain range in normal clinical practice, which is 22- 26 centigrade. Warm feeling will make skin vassal dilated and more blood will pass through to bring more heat out of our body. It had been reported that a bigger venous vessels will get less propofol injection pain.

The investigators hypothesis that Patients who stayed in a warmer room temperature will surf less injection pain while compare to a normal setting room temperature.


Eligibility criteria: Inclusion Criteria:

* ASA I\~III, aged 18，scheduled or emergency surgery with general anesthesia.

Exclusion Criteria:

* a history of allergy to propofol, allergy to soybean oil
* with peripheral blood diseases.

Primary outcomes:
measure: intensity of injection pain
timeFrame: 3 months
measure: numbers of lidocaine rescues for severe injection pain
timeFrame: 3 months
measure: incidences of injection pain
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chenzhou
country: China
facility: Chenzhou No.1 People's hopital
state: Hunan
Study officials:
References:
Clinical trial NCT03853460: Bilateral Quadraus LUMBORUM Block in Patients Under Going Cystectomy
Official title: Bilateral Quadraus LUMBORUM Block in Patients Under Going Cystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Acute
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: ultrasound guided quadratus lumborum will be given for patients under going partial or complete urinary bladder removal.

Detailed description: ultrasound guided quadratus lumborum will be given for patients under going partial or complete urinary bladder removal.

Eligibility criteria: Inclusion Criteria:

* elective surgery
* patients between 30 and 60 years

Exclusion Criteria:

* coagulopathy
* infection at insertion site
* patient refusal

Primary outcomes:
measure: pain score
timeFrame: 24 hours
Secondary outcomes:
measure: anaesthetic consumption
timeFrame: 4 hours
measure: diaphragmatic excursion
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
city: Asyut
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT00219960: The Effect of North American Ginseng on Blood Pressure in Individuals With Hypertension
Official title: The Effect of North American Ginseng on Blood Pressure in Individuals With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension
Blood Pressure
Ambulatory Blood Pressure Monitoring
Complementary and Alternative Medicine
Herbal
North American Ginseng
Panax Quinquefolius
Lead sponsor: Risk Factor Modification Centre
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Agriculture, Food and Rural Affairs
name: Ontario Ginseng Growers Association
First posted: 2005-09-22
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine the effect of North American ginseng on blood pressure in individuals with hypertension.

Detailed description: Ginseng lacks proper clinical scrutiny for its effect on blood pressure (BP), in spite of observational evidence linking its intake to hypertension. This should be addressed considering the potential overlap between the prevalence of ginseng use and hypertension.

We undertook a single centre, randomized, controlled, double-blinded, crossover trial to determine the effect of North American ginseng (NAG) on 24-hour BP and renal function. After a 4-week placebo run-in, we randomly assigned participants to NAG or placebo treatment for 12-weeks at a dose of 3g/day. This was followed by an 8-week washout, and a subsequent 12-week period in which the opposite treatment was consumed. At run-in, and at weeks 0 and 12 of each treatment period, participants were fitted with an ambulatory BP monitor to assess 24-hour BP and serum cystatin C was measured.

Eligibility criteria: Inclusion Criteria:

* aged 18 to 85 years
* hypertension as defined by the use of antihypertensive drugs or a seated systolic blood pressure greater than or equal to 140 mm Hg or a diastolic BP greater than or equal to 90 mm Hg at each of 3 pre-study visits.

Exclusion Criteria:

* secondary hypertension
* diabetes
* kidney
* liver disease
* unstable angina
* ginseng use for two months prior to or during the study
* any changes in the type or dose of antihypertensive drugs one month prior to or during the study

Primary outcomes:
measure: Mean 24 Hour Ambulatory Blood Pressure
Secondary outcomes:
measure: Mean Daytime Ambulatory Blood Pressure
measure: Mean Nighttime Ambulatory Blood Pressure
measure: Cystatin C
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Risk Factor Modification Centre, St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Risk Factor Modification Centre, St. Michael's Hospital
name: Vladimir Vuksan, PhD
role: PRINCIPAL_INVESTIGATOR
References: