louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02652325: Nasal Swab studyComparison of Effectiveness of Povidone-iodine Versus Saline Versus 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP Swabs for Decolonizing Intranasal MSSA/MRSA
Official title: Comparison of Effectiveness of Povidone-iodine Versus Saline Versus 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP Swabs for Decolonizing Intranasal MSSA/MRSA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: MRSA/ MSSA Colonization of the Nares
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2016-01-11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: To determine if routinely available 10% povidone-iodine swabs are more effective than saline and 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP for decolonizing MRSA.


Eligibility criteria: Inclusion Criteria:

1. All potential total hip and total knee arthroplasty candidates
2. All femoroacetabular osteoplasty patients
3. All pelvic acetabular osteotomy patients
4. All core decompression patients

Exclusion Criteria:

1. Any trauma patients
2. Any tumor patients
3. Any patient with periprosthetic joint infection
4. Any patient with surgical site infection
5. Any patient with known MRSA infection
6. Any patients allergic to povidone-iodine
7. Patients with thyroid disease

Primary outcomes:
measure: MSSA/MRSA colonization in the nares
timeFrame: 4 hours
measure: MSSA/MRSA colonization as tested by PCR
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Rezapoor M, Nicholson T, Tabatabaee RM, Chen AF, Maltenfort MG, Parvizi J. Povidone-Iodine-Based Solutions for Decolonization of Nasal Staphylococcus aureus: A Randomized, Prospective, Placebo-Controlled Study. J Arthroplasty. 2017 Sep;32(9):2815-2819. doi: 10.1016/j.arth.2017.04.039. Epub 2017 May 3.
Clinical trial NCT01335425: The Rolandic Epilepsy/ESES/Landau-Kleffner Syndrome and Correlation With Language Impairment Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rolandic Epilepsy
Nocturnal Frontal Lobe Epilepsy
Landau-Kleffner Syndrome
Electrical Status Epilepticus During Slow Wave Sleep
Keywords: Language problems
childhood epilepsy
bening (rolandic) epilepsy (of childhood) with centro temporal spikes
brain maturation
structral connectivity
functional connectivity
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Epilepsiecentrum Kempenhaeghe
First posted: 2011-04-14
Enrollment: 47
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 6 to 18 years seen in tertiary referral center for epilepsy Kempenhaeghe with a proven diagnosis of Rolandic epilepsy and without intracerebral lesions (e.g. tumour) on structural MRI or other pathology, which may influence cognition.

In addition, children with electrical status epilepticus of sleep (ESES), ESES-like, or Landau-Klefner syndrome might be included.

Brief summary: In clinical practice language impairment is frequently reported in association with nocturnal epileptiform activity. There is a spectrum of epileptic conditions that are characterized by nocturnal epileptiform activity. From mild to severe this spectrum involves: Rolandic epilepsy (RE), nocturnal frontal lobe epilepsy (NFLE), Landau-Kleffner syndrome (LKS) and electrical status epilepticus during slow wave sleep (ESES). The exact characteristic of the relationship between nocturnal epileptiform activity and language impairment is yet to be explored. The investigators suggest that nocturnal epileptiform EEG discharges and nocturnal epileptic seizures during development will cause diseased neuronal networks that involve language. The diseased neuronal networks are less efficient compared with normal neuronal networks.

Objective: Identification of a diseased neuronal network characteristic in children with nocturnal epileptiform activity, which can explain language impairment in these children. For this the investigators will use functional magnetic resonance imaging (MRI) to analyse brain activity and diffusion weighted MRI to investigate white matter connectivity.


Eligibility criteria: Inclusion Criteria:

* aged between 6-18
* diagnosis of Rolandic epilepsy (or other childhood epilepsies as listed in study population description)

Exclusion Criteria:

* structural brain lesions which might influence cognition

Primary outcomes:
measure: Mechanism that causes language problems in childhood epilepsy
timeFrame: course of study
Secondary outcomes:
Other outcomes:
Locations:
city: Heeze
country: Netherlands
facility: Epilepsiecentrum Kempenhaeghe
state: Noord-Brabant
Study officials:
References:
Clinical trial NCT02284425: Study of REGN1193 in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-11-06
Enrollment: 72
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of REGN1193 in patients with Type 2 Diabetes Mellitus.


Eligibility criteria: Inclusion Criteria:

1. Metformin monotherapy at a dose of ≥1000 mg/day (up to the maximum daily dose of 2550 mg per day) for ≥8 weeks prior to randomization
2. Hemoglobin A1c value of ≥7.0% to ≤10.0%
3. Fasting plasma glucose value ≥130 mg/dL and ≤240 mg/dL

Exclusion Criteria:

1. Type 1 diabetes mellitus
2. Use of insulin or oral or injectable antihyperglycemic medications during the 8 weeks prior to randomization
3. A severe hypoglycemic event in the 6 months prior to randomization

Note: The eligibility criteria listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.

Primary outcomes:
measure: Incidence and severity of treatment emergent adverse events (TEAEs)
timeFrame: Day 1 through Day 57
Secondary outcomes:
measure: Pharmacodynamic profile of REGN1193 as measured by plasma glucose over time
timeFrame: Day 1 through Day 57
measure: Concentration of REGN1193 in serum over time
timeFrame: Day 1 through Day 57
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Knoxville
country: United States
state: Tennessee
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
Clinical trial NCT04962425: Risk Assessment Model of Trastuzumab-related Cardiotoxicity in Breast Cancer Patients
Official title: Risk Assessment Model of Trastuzumab-related Cardiotoxicity in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Toxicity
Antitumor Drugs
Breast Cancer
Keywords: Cardiac Toxicity
Antitumor drugs
Breast Cancer
Trastuzumab
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects were women aged \>18 years, diagnosed with HER2-positive breast cancer and already receiving trastuzumab treatment.

Brief summary: According to the existing clinical data in our hospital, retrospective study was conducted to screen the risk factors with predictive value for TRC(trastuzumab-related cardiotoxicity) risk, and to construct the risk prediction model for TRC.

Detailed description: The breast cancer patients with cardiotoxicity caused by trastuzumab were selected as the case group, and the breast cancer patients without cardiotoxicity were selected as the control group. The clinical baseline data, echocardiographic parameters and serum markers of the case group and the control group were compared to find out the risk factors that may have predictive value for the risk of TRC. The target factors were analyzed by univariate analysis and multivariate Logistic regression analysis, and the TRC risk prediction model was established.

Eligibility criteria: Inclusion Criteria:

1. Female patients diagnosed with HER2-positive breast cancer treated in our hospital.
2. Surgical treatment combined with chemotherapy or radiotherapy was completed according to NCCN guidelines, and trastuzumab standard treatment was received for at least half a year.

(3) Cardiac function (including echocardiography or biomarkers) was assessed at least once within 3 months before trastuzumab treatment, and at least once during or after treatment was performed for heart-related tests.

(4) Complete case data.

Exclusion Criteria:

1. Patients who have not been properly treated with trastuzumab or have been treated for less than half a year;
2. Patients who did not receive cardiac function assessment before trastuzumab treatment, during or after treatment;
3. Patients whose case data were missing or lost to follow-up.

Primary outcomes:
measure: Cardiac toxicity
timeFrame: 12 months
measure: Cardiac toxicity
timeFrame: 12 months
measure: Cardiac toxicity
timeFrame: 12 months
measure: Cardiac toxicity
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02328625: Scleroderma Treatment With Celution Processed ADRCs Registry
Official title: Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (ADRCs) Registry
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Scleroderma
Keywords: Scleroderma
Device
ADRCs
adipose derived regenerative cells
hand
Lead sponsor: Cytori Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-12-31
Enrollment: 0
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: Patients who are scheduled to receive or have received ADRCs prepared by Celution to treat hand scleroderma.

Brief summary: This registry study will assess the safety and performance of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand scleroderma.

Detailed description: This registry study will assess the safety and performance of the Celution System in preparation of adipose derived regenerative cells in the treatment of scleroderma affecting the hands. This will be a multi-center, multi-national study.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of scleroderma and presence of hand scleroderma
* Cochin score ≥ 20 units

Exclusion Criteria:

* Body Mass Index \< 17 kg/m2
* Infection in any finger
* Stable medications for the treatment of scleroderma for ≥ 1 month
* Pregnant or lactating status.

Primary outcomes:
measure: Change in Cochin score
timeFrame: Day 90
Secondary outcomes:
measure: Change in Cochin score
timeFrame: Days 30 and 180
measure: Scleroderma Health Assessment Questionnaire (SHAQ)
timeFrame: Days 7, 30, 90 and 180
measure: Physician and Patient Global Assessment
timeFrame: Days 7, 30, 90 and 180
measure: Raynaud's Condition Score
timeFrame: Days 7, 30, 90 and 180
measure: EQ-5D
timeFrame: Days 7, 30, 90 and 180
Other outcomes:
Locations:
Study officials:
affiliation: Cytori Therapeutics
name: Steven Kesten
role: STUDY_CHAIR
References:
Clinical trial NCT00177125: Evaluating the Effect of the VCD on Erectile Function and Penile Length Post RRP
Official title: Evaluating the Effect of the Vacuum Constriction Device on Erectile Function and Penile Length Post Radical Retropubic Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostatic Neoplasms
Prostatectomy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Endocare, Inc.
name: Manoj, Monga, M.D.
First posted: 2005-09-15
Enrollment: 220
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to perform a randomized prospective study to evaluate whether the vacuum erection device facilitates an earlier return of erectile function post radical prostatectomy. A secondary measure will be to evaluate if the vacuum erection device can help prevent penile shortening.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing a radical prostatectomy for prostate cancer who are able to attain a partial or full erection preoperatively and are sexually active.

Exclusion Criteria:

* Patients on anticoagulation therapy and those with bleeding diatheses
* Insufficient manual dexterity of patient or spouse
* IIEF(International Index of Erectile Function) at baseline \< 11, indicating severe erectile dysfunction

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: VAMC Minneapolis
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota and VAMC Minneapolis
name: Manoj Monga, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01071525: The Effect of Niacin Administration on Oxidative Stress in Patients With Hypercholesterolmia, as Measured by the Use of a Novel Biomarker
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2010-02-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 1. Treatment of Hypercholesterolemic patients with niacin will cause a significant decrease in oxidative stress and a decrease in the atherogenecity in blood samples of the patients.
2. A possible correlation between oxidative stress in hypercholesterolemic patients taking niacin to clinical hypercholesterolemia parameters is possible.
3. Using a novel biomarker will enable a precise detection of the change in the oxidative stress in hypercholesterolemic patients.


Eligibility criteria: Inclusion Criteria:

* Hypercholesterolemia,
* age above eighteen

Exclusion Criteria:

* Treatment with fibrates,
* Pregnant/Breast feeding women

Primary outcomes:
measure: Effect on oxidative stress
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Study Coordinator
name: Liz Phima
role: STUDY_DIRECTOR
References:
Clinical trial NCT06136325: Treatment of Anal Fistulas With Obsidian RFT®
Official title: Treatment of Anal Fistulas With Obsidian RFT® - a Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anal Fistula
Minimal Invasive Surgery
Platelet-rich Fibrin Foam
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients, receiving an anal fistula closure with Obsidian RTF®, were included into the final analysis.

Brief summary: The study conducted a retrospective analysis from January 2018 to December 2022 on patients who received anal fistula closure with Obsidian RTF® at the Department of General Surgery, Medical University of Vienna.

Detailed description: Anal fistulas present a significant challenge in colorectal surgery, featuring abnormal passages between the anal canal and surrounding tissues. Traditional treatments, while effective, may risk damaging the anal sphincter complex and subsequent fecal incontinence. Sphincter-preserving techniques like autologous compound platelet-rich fibrin foam have gained popularity, offering potential for better functional outcomes in anal fistula treatment. In this context, our retrospective study aims to evaluate the efficacy and safety of autologous compound platelet-rich fibrin foam, specifically Obsidian RFT®, analyzing its success in fistula closure and functional outcomes, thus contributing to the advancement of sphincter-preserving methods in anal fistula management.

The study conducted a retrospective analysis from January 2018 to December 2022 on patients who received anal fistula closure with Obsidian RTF® at the Department of General Surgery, Medical University of Vienna.

Clinical diagnosis, complemented by radiographic imaging, was employed to confirm inconclusive cases.

Demographic, comorbidity, fistula characteristics, and postoperative data were collected from electronic records.

Eligibility criteria: Inclusion Criteria:

* patients who received anal fistula closure with Obsidian RTF® at the Department of General Surgery, Medical University of Vienna

Exclusion Criteria:

* unclear documentation

Primary outcomes:
measure: Closure rate anal fistula
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Christopher Dawoud, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06383325: Livertoxcicity in Acute Leukemia Patients During Chemotherapy Treatment
Official title: Evaluation of Liver Function Test to Identify Hepatotoxcicity Among Acute Leukemia Patients Who Are Receiving Chemotherapy Induction
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Liver Toxicity, Chemically-Induced
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who will be diagnosed as acute leukemia and going to receive chemotherapy after

Brief summary: Detection of hepatotoxcicity in acute leukemia and study the outcome of acute leukemia patients that suffer from hepatic toxiciyt

Detailed description: Chemotherapy induction associated with hepatotoxicity during the induction has never been studied the study aimed to determine whether chemotherapy induction is associated with livertoxicity or not

Eligibility criteria: Inclusion Criteria:

* patients newly diagnosed with acute leukemia who are going to start chemotherapy treatment

Exclusion Criteria:

* patients previously diagnosed Acute leukemia and started treatment or in post treatment follow up

Primary outcomes:
measure: Detection of hepatotoxcicity in acute leukemia during chemotherapy treatment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Mekonnen AT, Wondmeneh TG. Evaluation of liver function tests to identify hepatotoxicity among acute lymphoblastic leukemia patients who are receiving chemotherapy induction. Sci Rep. 2022 Aug 2;12(1):13215. doi: 10.1038/s41598-022-17618-w.
Clinical trial NCT02281825: Correlating Real and Virtual World Behavioral Fluctuations in Adolescence
Official title: Correlating Real and Virtual World Behavioral Fluctuations in Adolescence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention-Deficit and Hyperactivity Disorder
Anxiety
Disruptive Mood Dysregulation Disorder
Depression
Oppositional Defiant Disorder
Conduct
Keywords: Attention-Deficit and Hyperactivity Disorder
Anxiety
Impulsivity
Computer Games
Depression
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
Collaborators: name: University of Haifa
First posted: 2014-11-04
Enrollment: 20
Sex: MALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male adolescents, 13-18, with and without psychopathology, evaluated and diagnosed by psychiatrists. Adolescents will be recruited from Shalvata MHC children and adolescents outpatient clinic and from convinience sample in the community.

Brief summary: The present study will explore a new approach to ongoing evaluation and monitoring of fluctuations in personality traits via commercial video games. The aim of this longitudinal study is to examine the influence of everyday life event on video games performance as a function of individual differences in gaming behavioral patterns. focusing on the ongoing performance vacillations of the patient on commercial video games will offer insights in to possibly new generation of real time assessment medium of ongoing behavior.


Eligibility criteria: Inclusion Criteria:

* All subjects will have normal or corrected to normal vision with no sensory/motor disturbance
* An accessible computer at the house hold
* Previous experience in playing computer games.

Exclusion Criteria:

* drug abuse
* head injury
* living in a boarding school and a major psychiatric or neurological disorder.

Primary outcomes:
measure: Impulsivity manifested within game-play
timeFrame: 3 weeks
measure: Activity manifested within game-play
timeFrame: 3 weeks
measure: Aggresion manifested within game-play
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hod Hasharon
country: Israel
facility: Shalvata MHC
Study officials:
affiliation: Shalvata MHC, Sackler Faculty of Medicine, TA Uni.
name: Aviv Segev, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03509025: Follow-up Study for Participants Jointstem Clinical Trial
Official title: Open, Multicenter Follow-up Trial About Active Group of Phase IIb Clinical Trial of JOINTSTEM in Patients With Degenerative Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Knee Osteoarthritis
Lead sponsor: R-Bio
Sponsor class: INDUSTRY
First posted: 2018-04-26
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a long term follow-up study to investigate the safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Knee Osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Patients must consent in writing to participate in the study by signing and dating an informed consent document
* Patients who transplanted Jointstem on phase 2b clinical trial

Exclusion Criteria:

* Preparing for Pregnancy or Pregnant women or lactating mothers.
* Patients who the principal investigator considers inappropriate for the clinical tria

Primary outcomes:
measure: Adverse Events
timeFrame: 60 months
Secondary outcomes:
measure: WOMAC score
timeFrame: Baseline and 12 months
measure: WOMAC 3 subscale score
timeFrame: Baseline and 12 months
measure: X-ray
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: KyungHee University Gangdong Hospital
city: Seoul
country: Korea, Republic of
facility: GangNam Severance Hospital
Study officials:
affiliation: KyungHee University Gangdong Hospital
name: KangIl Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: