louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01310673: Initiation of Allopurinol at First Medical Contact for Acute Attacks of Gout
Official title: Therapy for Acute Gout: Does Initial Use of Allopurinol Effect Duration and/or Recurrence Rate of Acute Attacks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gout
Gout Acute
Keywords: Gout
Allopurinol
Acute gout
Lead sponsor: White River Junction Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2011-03-08
Enrollment: 57
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Medical teaching suggests allopurinol should not be initiated in the setting of an acute attack of gout, as rapid lowering of serum urate may exacerbate the attack. This study tests the hypothesis that there is no difference in patient reported daily pain or flair occurrences with early versus delayed institution of allopurinol during an acute gout attack.

Detailed description: Design: Randomized, placebo-controlled, double-blind trial. Setting: Outpatient clinics, White River Junction Veterans Affairs Medical Center.

Patients: 57 men with crystal proven acute gout attack, at first medical contact, and within 7 days onset.

Intervention: Subjects were randomized to receive allopurinol 300mg daily or matching placebo for 10 days. All patients received indomethacin 50mg TID for 10 days, prophylactic dose colchicine 0.6mg BID for 90 days, and open-label allopurinol starting at day 11.

Measurements: Primary outcomes were patient reported pain on visual analogue scale (VAS) for the primary joint, and self reported flares in any joint days 1-30. Secondary endpoints included urate, sedimentation rates, C-reactive protein levels.

Eligibility criteria: Inclusion Criteria:

* First medical contact for acute attack of gout.
* ACR criteria for acute attack of gout
* Crystal proven by arthrocentesis on day of enrollment
* Primary gout

Exclusion Criteria:

* Secondary Gout
* Tophaceous Gout
* Prior steroid, colchicine, or uric acid lowering therapy in the past 6 months.
* Uncontrolled CHF
* Unstable angina
* Renal insufficiency (entry CREAT \> 1.3)
* Anticoagulant therapy
* Immunosuppressive therapy or chemotherapy in the past 6 months
* Pregnancy; OR
* Known allergy to NSAID, colchicine, or allopurinol

Primary outcomes:
measure: Daily pain scores and recurrence attack rate.
timeFrame: 30 days after initiation of treatment
Secondary outcomes:
measure: sedimentation rates and C-reactive protein at 0, 3, 10, and 30 day visits
timeFrame: 30 days
Other outcomes:
Locations:
city: White River Junction
country: United States
facility: White River Junction VA Medical Center
state: Vermont
Study officials:
affiliation: White River Junction VA Medical Center
name: Thomas H Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taylor TH, Mecchella JN, Larson RJ, Kerin KD, Mackenzie TA. Initiation of allopurinol at first medical contact for acute attacks of gout: a randomized clinical trial. Am J Med. 2012 Nov;125(11):1126-1134.e7. doi: 10.1016/j.amjmed.2012.05.025.
Clinical trial NCT02090673: Post-Marketing Surveillance Study: 12 To 24 Weeks Study On The Treatment Emergent Adverse Events In Patients With Type 2 Diabetes Taking Exenatide In Korea
Official title: Post-Marketing Surveillance Study: 12 To 24 Weeks Study On The Treatment Emergent Adverse Events In Patients With Type 2 Diabetes Taking Exenatide In Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus Type 2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-03-18
Enrollment: 1711
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic, hospital and teaching hospitals

Brief summary: The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the clinical usefulness of Exenatide through collecting, reviewing, identifying and verifying the safety and effectiveness information about Exenatide in general practice.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Male or female at least 18 years of age
* Patients who are to initiate Exenatide treatment for type 2 diabetes at baseline, following their treating physicians' advice
* Patients, who in the opinion of the treating physicians, comply with all the recommendations stated in the relevant product information

Exclusion Criteria:

* Are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug
* Are pregnant or have intentions of becoming pregnant within the duration of the study
* Contraindications

Primary outcomes:
measure: The proportion of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients who are treated with Exenatide for type 2 diabetes mellitus
timeFrame: At 12 weeks ± 4 weeks or 24 weeks ± 4 weeks
Secondary outcomes:
measure: Change from baseline to endpoint in Hemoglobin A1c (HbA1c)
timeFrame: Baseline (Day 1) and 12 or 24 weeks ± 4 weeks
measure: Change from baseline to endpoint in Body weight
timeFrame: Baseline (Day 1) and 12 or 24 weeks ± 4 weeks
measure: Change from baseline to endpoint in Fasting plasma glucose
timeFrame: Baseline (Day 1) and 12 or 24 weeks ± 4 weeks
measure: Change from baseline to endpoint in subjective measures include improvement of main indication
timeFrame: Baseline (Day 1) and 12 or 24 weeks ± 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Hwang YC, Kim A, Jo E, Yang Y, Cho JH, Lee BW. Effectiveness and safety of exenatide in Korean patients with type 2 diabetes inadequately controlled with oral hypoglycemic agents: an observational study in a real clinical practice. BMC Endocr Disord. 2017 Oct 25;17(1):68. doi: 10.1186/s12902-017-0220-4.
Clinical trial NCT04912973: Assessment With Gait Analysis of Robotic Total Knee Arthroplasty Using Inverse Kinematic Alignment
Official title: Clinical & Biomechanical Outcome After Robotic Total Knee Arthroplasty by Comparing Inverse Kinematic Alignment and Mechanical Alignment - Gait Analysis and Performance Testing
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: total knee arthroplasty
robotic surgery
alignment
inverse kinematic alignment
mechanical alignment
gait analysis
performance testing
Lead sponsor: AZ Delta
Sponsor class: OTHER
Collaborators: name: AZ Delta
First posted: 2021-06-03
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative function and patient satisfaction are becoming increasingly relevant in patients after knee arthroplasty surgery. Despite adequate preoperative planning, improved surgical techniques and rehabilitation protocols, only 75%-85% of patients seems satisfied after TKA procedurs. Implant positioning and component alignment are determining factors in patient outcome. Currently, different alignment strategies in TKA surgery are used such as Mechanical Alignment (MA) and Kinematical Alignment (KA). Recently, a new and individualized alignment strategy (inverse Kinematic Alignment/iKA) was introduced. Preliminary 1-year results of iKA are promising, however, clinical and functional outcome on the medium and longterm should be investigated. This project aims to compare patients with iKA TKA with MA TKA on clinical, functional and biomechanical outcomes.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent must be obtained prior to any screening procedures
2. Received a primary total knee replacement (incl. patella) robotically-assisted
3. Male or female
4. Age between 50 and 80
5. Able to walk independently

Exclusion Criteria:

1. Revision surgery
2. Patient with a history of neurological, psychiatric or neurodegenerative disease
3. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
4. Other musculoskeletal lesions that may affect the gait pattern

Primary outcomes:
measure: Gait Analysis - walking speed - faster is better
timeFrame: 2 year
measure: Performance Testing - step-up step-down speed - faster is better
timeFrame: 2 year
Secondary outcomes:
measure: Patient Reported Outcome Measures - Oxford Knee Score (OKS): maximum score (best) is 48/48; worst score is 0/48
timeFrame: baseline - 1 year - 2 year
Other outcomes:
Locations:
city: Roeselare
country: Belgium
facility: AZDelta
Study officials:
References:
Clinical trial NCT02961673: The Safety and Efficacy Study of HU-014 Versus Botox® in Subject With Moderate to Severe Glabellar Lines
Official title: A Phase I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 Versus Botox® in Subject With Moderate to Severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glabellar Lines
Lead sponsor: Huons Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-11-11
Enrollment: 57
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 versus Botox® in Subject with Moderate to Severe Glabellar Lines


Eligibility criteria: Inclusion Criteria:

* Facial Wrinkle Scale (FWS) score \> 2 when Subject knits brow extremely

Exclusion Criteria:

* Volunteer who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
* From screening, Subject who get a plastic Surgery including fascioplasty, Prosthesis implantation within 6 Weeks
* Subject who has skin disorder including infection and scar on injection site
* Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc.
* Subject who takes a medication including anticoagulant, antithrombotic drug except low dose aspirin (below 325 mg/day)
* Any condition that, in the view of the investigator, would interfere with study participation

Primary outcomes:
measure: Assessment of Treatment-Emergent Adverse events (TEAs), Adverse Drug Reactions (ADRs) and Serious Adverse Events (SAEs) after injecting Investigational Product(Phase 1)
timeFrame: Week 4
measure: Change from Baseline of Glabellar Lines improvement rate(Frown)
timeFrame: Week 4
Secondary outcomes:
measure: Assessment of Columbia Suicide Severity Rating Scale(C-SSRS)
timeFrame: Week 4, Week 8, Week 12
measure: change from Baseline of Glabellar Lines improvement rate (Frown)
timeFrame: Week 8, Week 12
measure: change from Baseline of Glabellar Lines improvement rate (Not frown)
timeFrame: Week4, Week 8, Week 12
measure: Efficacy Outcome Measure (Phase 2) by colleting Subject Satisfaction assessment
timeFrame: Week 4, Week 8, Week 12
measure: Assessment of TEAs (Treatment-Emergent Adverse events), ADRs (Adverse Drug Reactions) and SAEs (Serious Adverse Events) after injecting Investigational Product
timeFrame: Week 4, Week 8, Week 12
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Huons
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT03857373: Renal Cancer Detection Using Convolutional Neural Networks
Official title: Renal Cancer Detection Using Convolutional Neural Networks
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Cancer
Keywords: Renal Cancer
Machine Learning
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with RCC

Brief summary: We aim to experiment and implement various deep learning architectures in order to achieve human-level accuracy in Computer-aided diagnosis (CAD) systems. In particular, we are interested in detecting renal tumors from CT urography scans in this project. We would like to classify renal tumor to cancer, non cancer, renal cyst I, renal cyst II, renal cyst III and renal cyst VI, with high sensitivity and low false positive rate using various types of convolutional neural networks (CNN). This task can be considered as the first step in building CAD systems for renal cancer diagnosis. Moreover, by automating this task, we can significantly reduce the time for the radiologists to create large-scale labeled datasets of CT-urography scans.

Detailed description: We aim to experiment and implement various deep learning architectures in order to achieve human-level accuracy in Computer-aided diagnosis (CAD) systems. In particular, we are interested in detecting renal tumors from CT urography scans in this project. We would like to classify renal tumor to cancer, non cancer, renal cyst I, renal cyst II, renal cyst III and renal cyst VI, with high sensitivity and low false positive rate using various types of convolutional neural networks (CNN). This task can be considered as the first step in building CAD systems for renal cancer diagnosis. Moreover, by automating this task, we can significantly reduce the time for the radiologists to create large-scale labeled datasets of CT-urography scans.

Eligibility criteria: Inclusion Criteria:

* All patient with RCC, who underwent surgery

Exclusion Criteria:

* Patients with RCC, who did not underwent surgery

Primary outcomes:
measure: Predicting recurrences
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Zealand University Hospital
Study officials:
References:
Clinical trial NCT02931773: Autonomic Cardiovascular Neuropathy in Recently Diagnosed DM2 Patients (ACNDM2)
Official title: Autonomic Cardiovascular Neuropathy in Recently Diagnosed DM2 Patients and in Pre-Diabetes Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dysautonomia
Keywords: Diabetes Autonomic Cardiovascular
Lead sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those patients included as the cohorts of the GEA registry

Brief summary: The investigators are studying the initial autonomic alterations in participants recently diagnosed with DM2 and in those patients classified as Pre-Diabetes, mainly focused on the baroreceptor sensitivity and on the peripheral sympathetic innervation.

Detailed description: Until now the autonomic dysfunction in Diabetes Mellitus type 2 (DM2)has been broadly studied in long term patients. Thus, clinical features as cardiac autonomic neuropathy (CAN) and the lack of the baroreceptor reflex were widely described in patients with a long standing Diabetes. However, there hasn´t been a description of the initial autonomic imbalance in both Pre-Diabetes and recently diagnosed DM2 patients. This is the goal of the present research study, to assess the autonomic dysfunction among these sets of patients.

Yet CAN is finding mostly happening in late stages of DM2 and so the lack of Baroreceptor reflex sensitivity there are other subtle indicators of dysautonomia which hasn't been extensively analyzed. In fact, rest tachycardia and orthostatic intolerance may point to an early dysautonomia. A description of the impairment of the cardiovascular autonomic regulation is still missing. Therefore, the investigators intend to evaluate this regulation through the means of a Task Force System.

Eligibility criteria: Inclusion Criteria:

* patients who have not suffered Hypertension, Parkinson Diseae, Parkinsonic Syndrome, Guillain-Barré Disease, Myocardial Infarction, Obesity nor Ischemic Stroke

Exclusion Criteria:

* Those older than 55 years old, or younger than 18 years old.
* Those who have suffered Hypertension, Parkinson Diseae, Parkinsonic Syndrome, Guillain-Barré Disease, Myocardial Infarction, Obesity or Ischemic Stroke

Primary outcomes:
measure: Sympathetic hyperactivity in recently diagnosed DM2 patients
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Laboratio de Síncope
state: DF
Study officials:
affiliation: Instituto Nacional De Cardiología "Ignacio Chávez"
name: Manuel A Sierra-Beltrán, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04438473: Pectin Supplemented Enteral Feedings in Critically Ill Patients
Official title: The Effect of Pectin Supplement on Enteral Nutrition-related Complications in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Enteral Nutrition
Dietary Fiber
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The current study will enroll critically ill patients who are going to require enteral nutrition support and randomize them to standard formula enteral nutrition or pectin-supplemented enteral nutrition in 7 days. The occurrence of enteral nutrition-related complications will be recorded and compared between groups.

The study is trying to assess whether the use of pectin will improve the enteral nutrition-related complications in critically ill patients.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-80 years old, with informed consent to participate;
* Critically ill patients who require enteral nutrition support

Exclusion Criteria:

* Patients with lung infection at admission
* Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
* Lack of enteral access
* Any condition that would contraindicate use of the enteral nutrition
* Require enteral nutrition support for less than 1week or more than 4 weeks from enrollment

Primary outcomes:
measure: Complication of enteral feeding
timeFrame: 7 days
Secondary outcomes:
measure: feeding time of enteral nutrition
timeFrame: 7 days
measure: total energy intake
timeFrame: 7 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Huzhou
country: China
facility: Huzhou central hospital
state: Zhejiang
city: Jiaxing
country: China
facility: The first hospital of Jiaxing
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua municipal central hospital
state: Zhejiang
city: Quzhou
country: China
facility: Quzhou Kecheng People's Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Wenzhou
country: China
facility: The first affiliated hospital of Wenzhou medical university
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Pianhong Zhang, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02520973: Screening for TB in Pregnancy. on HIV-Infected Pregnant Women
Official title: Screening for TB in Pregnancy A Supplement to: The Effect of Tuberculosis and Its Treatment on HIV-Infected Pregnant Women and Their Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: University of Witwatersrand, South Africa
First posted: 2015-08-13
Enrollment: 1400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Pregnant women who develop active Tuberculosis (TB) are at increased risk of poor maternal and infant outcomes. Our data from South Africa show that up to 3% of HIV-infected pregnant women have active TB , many with advanced disease, contributing to the 40% of maternal mortality associated with TB or HIV in South Africa . Screening for TB in pregnant women in this setting is therefore essential to reduce maternal mortality. Symptom-directed screening for TB has been recommended by the World Health Organization and by the South African National Department of Health; however, no implementation framework is in place to operationalize the guidelines. Symptom-based testing is an efficient process that limits use of diagnostic tests, but may miss many cases. In Soweto, we found that 0.7% (700/100,000) of HIV-infected women had active TB when a symptom-based strategy was employed once, but in Klerksdorp we found that 3.3% (3,300/100,000) had active TB when universal testing, regardless of symptoms, was performed; most TB cases were newly diagnosed among women who reported no symptoms .


Eligibility criteria: Inclusion Criteria:

1. HIV seropositive by two rapid tests, or documented history of a positive Enzyme Immunoassay EIAs, or HIV RNA \>1000 copies/mL
2. Pregnancy confirmed by urine pregnancy test or clinical exam
3. Estimated gestational age of 13 weeks or older
4. Age 18 years or greater
5. Willing to provide verbal consent

Exclusion Criteria:

1. Currently diagnosed with TB
2. Completed TB treatment within the last 6 months
3. Inability to communicate in one of the study languages.
4. Lack of comprehension of the study based on inability to meet basic understanding questions during the screening process.

Primary outcomes:
measure: Proportion of women diagnosed with TB
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Klerksdorp
country: South Africa
facility: Perinatal HIV Research Unit
state: Northwest
Study officials:
affiliation: Johns Hopkins University
name: Richard Chaisson, MD
role: PRINCIPAL_INVESTIGATOR
References: