louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00001381: A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder
Official title: A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bladder Neoplasms
Carcinoma, Transitional Cell
Keywords: Adult
Intravesical Chemotherapy
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Patients with superficial transitional cell carcinoma of the bladder will be treated with intravesical suramin in a phase I dose escalating study. The toxicity of suramin administered in this fashion will be evaluated.

Detailed description: Patients with superficial transitional cell carcinoma of the bladder will be treated with intravesical suramin in a phase I dose escalating study. The toxicity of suramin administered in this fashion will be evaluated.

Eligibility criteria: DISEASE CHARACTERISTICS:

Histologically confirmed superficial transitional cell carcinoma of the bladder pathologically staged as Tis, Ta, or T1. Visible tumors at time of treatment not required. No metastatic disease or muscle invasion.

Clinically useful pretreatment bladder function required.

No significant prostatic obstructive symptoms associated with impaired or incomplete bladder emptying.

No active urinary tract infection.

PRIOR/CONCURRENT THERAPY:

At least 1 course of prior standard intravesical therapy required.

At least 4 weeks since intravesical treatment, with resolution of any local or systemic toxicity.

PATIENT CHARACTERISTICS:

Age: 18 and over.

Performance status: ECOG 0 or 1.

Hematopoietic:

WBC at least 3,300;

Hemoglobin at least 10 g/dL.

Hepatic:

Bilirubin no greater than 1.5 mg/dL;

AST and ALT no greater than 2 times normal.

Renal: Creatinine no greater than 1.5 mg/dL.

OTHER:

Medically able to undergo cystoscopy.

No pregnant women.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute (NCI)
state: Maryland
Study officials:
References:
citation: Gansler T, Vaghmar N, Olson JJ, Graham SD. Suramin inhibits growth factor binding and proliferation by urothelial carcinoma cell cultures. J Urol. 1992 Sep;148(3):910-4. doi: 10.1016/s0022-5347(17)36776-9.
citation: Walther MM, Figg WD, Linehan WM. Intravesical suramin: a novel agent for the treatment of superficial transitional-cell carcinoma of the bladder. World J Urol. 1996;14 Suppl 1:S8-11. doi: 10.1007/BF00182057.
citation: Walther MM, Trahan EE, Cooper M, Venzon D, Linehan WM. Suramin inhibits proliferation and DNA synthesis in transitional carcinoma cell lines. J Urol. 1994 Nov;152(5 Pt 1):1599-602. doi: 10.1016/s0022-5347(17)32486-2.
Clinical trial NCT05716581: Prognostic Factors for Ablation of Atrial Fibrillation
Official title: The Identification of Prognostic Factors for Patients Undergoing Ablation for Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atrial Fibrillation
Catheter Ablation
Spectral Analysis
Vectorcardiography
Heart Rate Variability
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients indicated for the catheter ablation for atrial fibrillation in our center will be enrolled.

Brief summary: The aim of the study is to find factors associated with sinus rhythm maintenance after catheter ablation for atrial fibrillation.

Detailed description: Catheter ablation presents the most effective kind of treatment for atrial fibrillation (AF). However, its efficacy is still limited, and AF reoccurs in approx. 30% of patients during the first year after ablation.

Several factors associated with AF recurrences were found, such as dilated left atrium, higher age, or the duration of AF before the ablation. As it was shown, the detailed analysis of the ECG before the ablation could also serve several important factors that could predict AF reoccurrence.

In the study, all participants who will be referred for AF ablation in the study center will be enrolled. Pre-procedural ECG on the day of the ablation (just during the procedure) will be analysed using several methods: 1) spectral analysis (dominant AF frequency will be determined), 2) heart rate variability (for time and frequency domain analysis), 3) vectorcardiography. All ECG recordings will be analyzed using matlab software.

All participants will have regular follow-up checks at 3, 6, and 12 months after ablation including 24-hour Holter recordings. Based on the rhythm presence during the follow-up, participants will be divided in two groups: 1) AF group (patients with AF recurrences) and 2) sinus rhythm (SR) group (patients without AF reoccurrence during follow-up). AF reoccurrence will be determined at a presence of AF or any other atrial tachycardia lasting \> 30 sec. The results of pre-procedural ECG analysis will be compared between both groups. Logistic regression will be done to determine optimal combination of parameters associated with AF freedom.

Eligibility criteria: Inclusion Criteria:

* atrial fibrillation

Exclusion Criteria:

* absent of informed content

Primary outcomes:
measure: AF reoccurrence during follow-up
timeFrame: 1 year after the ablation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04103281: Expression Profiles of Integrin αDβ2 on Neutrophils in Sepsis
Official title: Expression Profiles of Integrin αDβ2 on Neutrophils in Sepsis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 75
Sex: ALL
Minimum age (years): 2
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from 2-50 years old at Boston Children's Hospital either in an ICU with sepsis or a healthy control coming for a surgical procedure.

Brief summary: In this research study we want to learn more about the characteristics of neutrophils that are present in the blood and secretions from a breathing tube of patients with sepsis. Sepsis is a severe type of infection, affecting various parts of the body. Neutrophils are a type of white blood cell that are part of the body's immune system. Even though neutrophils are important in getting rid of germs, they also may be harmful to parts of the body by causing injury in the lungs in patients with sepsis. Neutrophils can change their character in sepsis. Because of this, it is important for doctors to know what kind of neutrophils are in the blood and secretions from the breathing tube of patients with sepsis so that they can work to develop therapies to prevent these cells from being harmful.


Eligibility criteria: Case Inclusion Criteria:

* sepsis patient in the ICU with a breathing tube

Control Inclusion Criteria:

* scheduled for an elective surgical procedure and need preoperative blood draw or will have an intravenous catheter placed for the purpose of their surgical procedure
* Plan to have endotracheal tube for planned procedures.

Exclusion Criteria:

* On chronic immunosuppressive drugs such as chronic corticosteroid use, or preexisting immunodeficiency diseases (oncology patients, patients with transplantation)

Primary outcomes:
measure: Neutrophil characteristics
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Koichi Yuki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00858481: A Pilot Dose Ranging Study of Spinosad Creme Rinse
Official title: Efficacy and Safety of Different Strengths of Spinosad Topical Creme (0%, 0.5%, 1.0% or 2%) in Subjects With Pediculosis Capitis - a Dose Ranging Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pediculosis Capitis
Head Lice
Keywords: Pediculosis capitis
Head Lice
Lead sponsor: ParaPRO LLC
Sponsor class: INDUSTRY
First posted: 2009-03-09
Enrollment: 36
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A pilot dose ranging study to evaluate the safety and efficacy of different strengths of Spinosad Creme versus a vehicle control.

Detailed description: A Phase 2a, randomized, single investigational site, investigator/evaluator-blind, four-arm, parallel-group, vehicle-controlled, pilot study to evaluate the safety and efficacy of different strengths of Spinosad Creme rinse verses vehicle control.

Eligibility criteria: Inclusion Criteria:

* Active head lice infestation
* Male or female, 2 years of age or older
* Good general health
* Appropriately signed Informed Consent
* Subject agreement to not use any other form of lice treatment during the course of the study
* Subject agreement to not cut or chemically treat their hair between visits

Exclusion Criteria:

* History of irritation or sensitivity to pediculicides or hair care products
* Individuals with any visible skin/scalp condition that would interfere with the evaluation
* Individuals previously treated with a pediculicide within 4 weeks prior to study enrollment
* Individuals using hair dyes, bleaches, permanent waves or relaxing solutions 2 weeks prior to study enrollment
* Individuals who have participated in any clinical trial within 30 days of enrollment
* Individuals with family members who were infested with lice but were unwilling or unable to enroll in the study or use a standard course of lice treatment
* Females who were pregnant or nursing
* Sexually active females not using effective contraception

Primary outcomes:
measure: Efficacy of various doses of Spinosad, based on the presence or absence of live lice at 7 and 14 days post-treatment. The efficacy evaluation was performed by a trained evaluator.
timeFrame: 14 days
Secondary outcomes:
measure: Safety of various doses of Spinosad, based on the occurrence of adverse events, especially scalp irritation.
timeFrame: 14 days
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: Hill Top Research
state: Florida
Study officials:
affiliation: Hill Top Research
name: Dyal Garg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02184481: Working Memory Training for Dysphoric Students
Official title: Working Memory Training to Decrease Depression, Anxiety and Rumination in Dysphoric Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Anxiety
Working memory
Rumination
Cognitive training
Executive functioning
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2014-07-09
Enrollment: 94
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Depression is associated with impairments in executive functions, including working memory (WM) which is needed to maintain and manipulate goal-relevant information. Due to these WM impairments depressed individuals have difficulties inhibiting and shifting from irrelevant (negative) information and updating goal relevant information. This study explored whether training WM decreases these impairments and reduces clinical symptoms of depression, anxiety and rumination. Sixty-one students with an elevated score on the BDI-II, representing a dysphoric mood state, executed a working memory training (n = 34) or placebo training (n = 27). Before and after training their depression, anxiety, rumination and working memory were assessed. Furthermore, they executed a working memory task while their pupil dilation was measured to assess their fatigue. Moreover, the investigators compared the dysphoric students with a healthy student population on all measures.


Eligibility criteria: Inclusion Criteria:

* BDI 10 of higher for dysphoric group
* BDI 5 or lower for healthy control group

Primary outcomes:
measure: Beck Depression Inventory Second Edition (BDI-II) score change between pre and post measurement
timeFrame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
Secondary outcomes:
measure: State-Trait Anxiety Inventory (STAI) scores change from pre to post training measurement
timeFrame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
Other outcomes:
measure: Ruminative Response Scale (RRS) score change between pre and post training
timeFrame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
measure: Spanboard task
timeFrame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
measure: N-back task
timeFrame: Pre training (baseline), post training (6 weeks after baseline, training starts 1 day after baseline)
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University Rotterdam
state: Zuid Holland
Study officials:
References:
citation: Hopstaken JF, Wanmaker S, van der Linden D, Bakker AB. Does Dysphoria Lead to Divergent Mental Fatigue Effects on a Cognitive Task? PLoS One. 2015 Jun 15;10(6):e0130304. doi: 10.1371/journal.pone.0130304. eCollection 2015.
Clinical trial NCT02714881: Lipids, Inflammation, and CV Risk in RA
Official title: Lipids, Inflammation, and Cardiovascular Risk in Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Cardiovascular Disease
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2016-03-22
Enrollment: 76
Sex: ALL
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The objective of this study is to elucidate the relationship between inflammation and lipoprotein atherogenicity, and to determine the relative contribution of inflammation and lipids to CV risk in RA. The central hypothesis of this study is that inflammation and lipoprotein atherogenicity is tightly linked such that both factors are important to assess CV risk in RA. Further, the investigators hypothesize that this relationship is obscured by a consideration of routine lipids alone.


Eligibility criteria: Inclusion Criteria:

* RA diagnosed by a rheumatologist
* Fulfills the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Criteria for RA
* Age\>35
* Active RA as defined by treating rheumatologist
* Biologic DMARD naive

Exclusion Criteria:

* Patients on statin or PCSK9 inhibitor therapy
* Corticosteroid therapy \>10mg prednisone or its equivalent as a maintenance treatment
* Pregnancy
* Unstable angina (chest pain) or shortness of breath
* Severe valvular heart disease
* Myocarditis
* Pericarditis
* Asthma with active wheezing
* History of lymphoproliferative disease or melanoma (stage two or higher), active malignancy, or cancer treatment in the last 5 years
* Active infectious disease (HIV, Tuberculosis, or Hepatitis B/C)

Primary outcomes:
measure: coronary flow reserve (CFR) measured by cardiac PET
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Katherine P Liao, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weber B, Weisenfeld D, Seyok T, Huang S, Massarotti E, Barrett L, Bibbo C, Solomon DH, Plutzky J, Bolster M, Di Carli M, Liao KP. Relationship Between Risk of Atherosclerotic Cardiovascular Disease, Inflammation, and Coronary Microvascular Dysfunction in Rheumatoid Arthritis. J Am Heart Assoc. 2022 Jun 7;11(11):e025467. doi: 10.1161/JAHA.121.025467. Epub 2022 Jun 3. No abstract available.
Clinical trial NCT03870581: AI-based Social Software to Manage wARfarin Therapy
Official title: Artificial Intelligence-based Social Software Management Model to Improve Warfarin Anticoagulation Therapy: a Prospective, Single-blind, Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anticoagulant-induced Bleeding
Warfarin Sodium Causing Adverse Effects in Therapeutic Use
Keywords: Artificial intelligence
social software
warfarin
anticoagulation therapy
INR
Lead sponsor: Wuhan Asia Heart Hospital
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators have demonstrated that social software could improve warfarin therapy quality by Human management. however,the efficiency of management will decline if patients' number expands huge. So it is needed that a human-like and automatic management tool could replace the human work. The aim of this study is to evaluate whether an AI-based social software management model could replace human to guide warfarin therapy.

Detailed description: 1. The investigators have developed an AI-based miniprogram, and embedded in the Wechat social application.
2. The investigators invited patients receiving warfarin therapy to participant this randomized controlled trial .
3. Participants were randomized to the experimental group and control group in a ratio of 1:1.
4. Participants' warfarin therapy were managed by an AI-based social miniprogram and a Human-based social miniprogram respectively.
5. International normalized ratio(INR) was monitored once a month at least, and the time in therapeutic range was calculated to evaluate the warfarin anticoagulation quality.
6. Participants were followed-up for 24 months, and clinical events, including major bleedings and thrombotic events were recorded during follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients with Atrial fibrillation
* Patients with Mechanical valve replacement
* Patients receiving warfarin therapy

Exclusion Criteria:

* Plan to stop warfarin therapy within 1 years
* Bleeding within 3 months
* Refuse to participate in this study
* Other conditions that the physician considers inappropriate for participation

Primary outcomes:
measure: Time in therapeutic range
timeFrame: 24 months
measure: INR variability
timeFrame: 24 months
Secondary outcomes:
measure: Bleeding events
timeFrame: 24 months
measure: Thrombotic events
timeFrame: 24 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: WAHH
state: Hubei
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT05044481: "Impact of the Third Molars in Oral Health-related Quality of Life"
Official title: "Impact of the Third Molars in Oral Health-related Quality of Life"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health-related Quality of Life
Third Molar
Keywords: Health-related quality of life
third molar
Lead sponsor: Hospital Carlos Van Buren
Sponsor class: OTHER
Collaborators: name: Universidad de La Frontera
First posted: 2021-09-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years old submmited to third molars surgical removal

Brief summary: The aim of this study is to evaluate the impact of the third molars in oral health-related quality of life, before and after surgical removal using a validated and frequently used in international investigations instrument (OHIP-14).

Detailed description: This is a prospective study that evaluates the oral health-related quality of life through the application of the self-administered OHIP-14 before and after the surgical removal of third molars. The inclusion criteria were adults' patients older than 18 years, referred for oral surgery. Patients with chronic diseases and acute pericoronitis were excluded. The assessment was performed at three times: pre-surgical planning 1 day before surgery (T0), 10 days (T1) and 2 - 3 months after surgery (T2)

Eligibility criteria: Inclusion Criteria:

* Adults patients over 18 years old

Exclusion Criteria:

* Patients with chronic diseases and acute pericoronitis

Primary outcomes:
measure: changes in oral health related quality of life after orthognathic surgery assessed with Short form Oral Health Impact Profile (OHIP-14)
timeFrame: baseline to 10 days and 2 - 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Valparaíso
country: Chile
facility: Valentina Duarte
Study officials:
affiliation: Hospital Carlos Van Buren
name: Valentina Duarte
role: PRINCIPAL_INVESTIGATOR
References: