louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00661076: ADVANCE Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) + Adefovir Dipivoxil in Patients With Hbe(-) Chronic Hepatitis B
Official title: A Randomized, Open Label Study to Compare the Effect of Combination Treatment With PEGASYS + Adefovir Dipivoxil Versus PEGASYS Monotherapy on HBV-DNA and ALT Levels in Patients With HBeAg-negative, Chronic Hepatitis B.'
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-04-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 3 arm study will compare the efficacy and safety of combination therapy with PEGASYS + adefovir dipivoxil (ADV) versus PEGASYS monotherapy, in HBeAg-negative chronic hepatitis B patients.Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by ADV 10mg po monotherapy for an additional 48 weeks, and a further 48 week treatment-free follow-up, 2)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by a 96 week treatment-free follow-up, or 3)PEGASYS 180 micrograms sc monotherapy weekly for 48 weeks, followed by a 96 week treatment-free follow-up. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-70 years of age;
* chronic hepatitis B;
* positive HBsAg, positive anti-HBe, negative anti HBsAg, negative HBeAg for at least the prior 6 months;
* either nucleoside analogue naive, or has not received IFN-a in the past 6 months.

Exclusion Criteria:

* positive for hepatitis A, C, D or HIV;
* history or other evidence of a medical condition associated with chronic liver disease other than hepatitis B;
* antiviral, antineoplastic or immunomodulatory treatment \<=6 months prior to first dose of randomized treatment.

Primary outcomes:
measure: Normalization of ALT, and HBV-DNA <400 copies/mL
timeFrame: Week 96 for arm 1; week 48 for arms 2 and 3
measure: HBsAg quantitative loss and anti-HBs seroconversion
timeFrame: Weeks 48, 96 and 144
Secondary outcomes:
measure: AEs, lab parameters, vital signs
timeFrame: Throughtout study
Other outcomes:
Locations:
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Gaziantep
country: Turkey
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03513276: Effect of Local Infiltration Anesthesia in a Hip Arthroplasty Fast Track Program.
Official title: Effect of Local Infiltration Anesthesia in a Hip Arthroplasty Fast Track Program.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Osteoarthritis
Lead sponsor: Hospital Mutua de Terrassa
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fast-track programs in Orthopaedic Surgery require early motion that can only be achieved by optimal pain management protocols. Multimodal analgesia protocols including local infiltration anesthesia (LIA) have obtained excellent results in fast-track programs involving Total Knee Arthroplasty but further research and data is needed in Total Hip Arthoplasty programs.


Eligibility criteria: Inclusion Criteria:

* Hip osteoarthritis requiring Total Hip Replacement

Exclusion Criteria:

* Mental Disorders
* contraindications for epidural anesthesia
* Neurologic disorders that could interfere with pain evaluation
* allergy to drugs in multimodal analgesic protocol

Primary outcomes:
measure: Pain measured in Visual Analog Scale
timeFrame: Up to 48h postoperatively
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Up to 1 week
measure: Analgesic requirements
timeFrame: Up to 1 week
measure: Complications
timeFrame: Up to 1 week
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Hospital Universitari Mutua Terrassa
state: Barcelona
Study officials:
References:
citation: Bernaus M, Novellas M, Bartra A, Nunez JH, Angles F. Local infiltration analgesia does not have benefits in fast-track hip arthroplasty programmes: a double-blind, randomised, placebo-controlled, clinical trial. Hip Int. 2022 Nov;32(6):711-716. doi: 10.1177/1120700021992684. Epub 2021 Feb 18.
Clinical trial NCT03764176: Accuracy of Computer-assisted Template-based Implant Placement Using Conventional or Digital Impression
Official title: Accuracy of Computer-assisted Template-based Implant Placement Using Conventional Impression and Scan Model or Digital Impression: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Implant Failure
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Proper implant position has a significant impact in esthetic and functional outcomes of implant-supported restorations. Computer-assisted template-based implant placement (guided surgery) have become increasingly popular due to improved planning and the higher transfer accuracy of the virtual plan to the surgical site compared with freehand insertion or freehand final drilling. Digital impressions replace the need for traditional materials that can be inconvenient and messy for patients. To the best of our knowledge, at the time of planning this study, there were no published RCTs evaluating a fully digital approach for computer-assisted template-based implant placement.

The aim of the present study is to compare early implant failure, template-related complications, and virtual planning accuracy of computer-assisted template-based implant placement using conventional impression and scan model or digital impression.

The null hypothesis is that there will be no difference between these interventions.


Eligibility criteria: Inclusion Criteria:

* fully or partially edentulous patient, aged 18 years or older, able to sign an informed consent, in need of an implant-supported fixed restoration will be considered eligible for this study. Any potential implant locations based on individual patient requirements will be considered eligible in the present trial. No set location or group of locations will be excluded.

Exclusion Criteria:

* general medical contraindication to oral surgery (American Society of Anesthesiologist, ASA, class III or IV); irradiation in the head and neck area less than one year before implantation; psychiatric problems; alcohol or drug abuse; pregnant or nursing; untreated periodontitis; severe bruxism or clenching; uncontrolled diabetes; poor oral hygiene and motivation; and inability to complete the follow-up.

Primary outcomes:
measure: Linear distance between planned and real implant apex position
timeFrame: Immediate post-surgery
measure: Angle between the planned and real implant axis
timeFrame: Immediate post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis
Study officials:
References:
Clinical trial NCT05394376: Determining Change In Blood Pressure Due to Environment and Loudness
Official title: DECIBEL(S): Determining Change In Blood Pressure Due to Environment and Loudness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Vital Strategies
First posted: 2022-05-27
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: Determine the effects of environment and sound on initial and average triplicate screening blood pressure done according to clinical practice guidelines with an automated device.

Standardly obtained blood pressures obtained in a noisy, busy, public space will be higher than attended blood pressures obtained (1) in the same environment but with earplugs to minimize sound and (2) in a quiet, private space without surrounding activity.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years

Exclusion Criteria:

* Hearing loss requiring hearing aids
* Presence of the following on both arms: rashes, gauze dressings, casts, edema, paralysis, tubes, open sores or wounds, A-V shunts.
* Being mentally impaired
* Being pregnant
* Arm circumference exceeding 55 cm.

Primary outcomes:
measure: Difference between first systolic BP and average of 3 systolic BPs from measurements (mmHg)
timeFrame: Time of reading up to 90 minutes
measure: Difference between first diastolic BP and average of 3 diastolic BPs from measurements (mmHg)
timeFrame: Time of reading up to 90 minutes
measure: Systolic and Diastolic Differences in blood pressure measurement (mmHg)
timeFrame: Time of reading up to 90 minutes
Secondary outcomes:
measure: Difference in blood pressure measurement based on blood pressure level
timeFrame: Time of reading up to 90 minutes
measure: Difference in blood pressure measurement based on age
timeFrame: Time of measurement up to 90 minutes
measure: Difference in blood pressure measurement based on regular healthcare visits
timeFrame: Time of measurement up to 90 minutes
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Tammy Brady, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02027727: Individualized Infiximab Dosing-Proof of Concept Study
Official title: Individualized Infiximab Dosing-Proof of Concept Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Keywords: inflammatory bowel disease
infliximab
trough level
crohn's disease
ulcerative colitis
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2014-01-06
Enrollment: 56
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Males and females patients age 6 to 23

Brief summary: The purpose of this study is to determine which early infliximab pharmacokinetic level is most associated with clinical remission at weeks 30 and 54 in pediatric IBD patients.

Detailed description: Our aims are:

1. to determine which early pk level; week 6 (peak), week 8 (2 week) or week 14 (trough), is most associated with week 30 and 54 outcomes in pediatric IBD patients.
2. to determine if the forecasted PK determined by a newly developed Population PK Model software program is in agreement with the observed PK in IBD patients receiving infliximab.

Subject recruitment is limited to patients of the principal investigator only. Subjects will be approached for participation in the research in person during a routine clinic visit by a member of the study team.

Eligibility criteria: Inclusion Criteria:

1. Males and females on IFX
2. Patients with IBD
3. Age 6-23
4. Able to obtain consent

Exclusion Criteria:

1. Not receiving infliximab
2. On 10 mg/kg of IFX
3. Not able to obtain consent

Primary outcomes:
measure: Infliximab level and clinical remission at 54 weeks
timeFrame: 54 weeks
measure: Infliximab level and clinical remission at 30 weeks
timeFrame: 30 weeks
Secondary outcomes:
measure: Agreement between pk profiles predicted by the PK model and actual (measured) pk profiles
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Namita Singh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02091427: Circadian Variation of Cardiac Troponin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Individuals
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2014-03-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with no evidence of active cardiovascular disease

Brief summary: Acute myocardial infarction (AMI) is defined by an increase and/or decrease in the concentration of cardiac troponin, with at least one value above the 99th percentile value of the reference population together with evidence of ischemia. An objective tool to determine the magnitude of the cardiac troponin change is the use of reference change values (RCV). The basis for this tool is that, for a change to be significant, the difference in serial results must be greater than the inherent variation in two test results. The inherent variation of a laboratory test result is composed of analytical and within-subject biological variation. An important requirement to use RCVs is that the concentrations of cardiac troponins fluctuate randomly around a homeostatic set point in cardio-healthy individuals. Verification of this important condition has never been performed, and violation of this condition would preclude the use of RCV's in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Individuals with no evidence of active cardiovascular disease

Exclusion Criteria:

* History of acute myocardial infarction in the last year

Primary outcomes:
measure: cardiac troponins
timeFrame: measured every hour, total time 25h (08:30 day 1, till 09:30 day 2)
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
References:
citation: Breidthardt T, van Doorn WPTM, van der Linden N, Diebold M, Wussler D, Danier I, Zimmermann T, Shrestha S, Kozhuharov N, Belkin M, Porta C, Strebel I, Michou E, Gualandro DM, Nowak A, Meex SJR, Mueller C. Diurnal Variations in Natriuretic Peptide Levels: Clinical Implications for the Diagnosis of Acute Heart Failure. Circ Heart Fail. 2022 Jun;15(6):e009165. doi: 10.1161/CIRCHEARTFAILURE.121.009165. Epub 2022 Jun 7.
citation: Klinkenberg LJ, Wildi K, van der Linden N, Kouw IW, Niens M, Twerenbold R, Rubini Gimenez M, Puelacher C, Daniel Neuhaus J, Hillinger P, Nestelberger T, Boeddinghaus J, Grimm K, Sabti Z, Bons JA, van Suijlen JD, Tan FE, Ten Kate J, Bekers O, van Loon LJ, van Dieijen-Visser MP, Mueller C, Meex SJ. Diurnal Rhythm of Cardiac Troponin: Consequences for the Diagnosis of Acute Myocardial Infarction. Clin Chem. 2016 Dec;62(12):1602-1611. doi: 10.1373/clinchem.2016.257485. Epub 2016 Oct 5.
Clinical trial NCT01906827: P-wave Duration and Dispersion in Intrahepatic Cholestasis of Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intrahepatic Cholestasis of Pregnancy
Arrhythmia
Keywords: cholestasis
pregnancy
p wave dispersion
arrhythmia
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2013-07-24
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The pregnant women with intrahepatic cholestasis who admitted our clinic

Brief summary: The bile acids has been demonstrated to cause arrhythmia and abnormal calcium dynamics in cultured neonatal rat cardiomyocytes. Bile acids may alter maternal cardiomyocyte function like fetus.Increased P-wave duration and P-wave dispersion have been reported in various clinical settings. The investigators hypothesized that PWD and p wave duration may affect in pregnancy with ICP.

Detailed description: Intrahepatic cholestasis of pregnancy (ICP) is a pregnancy-specific liver disease. The most frequent laboratory abnormality is elevation of serum bile acid levels in ICP.

Bile acids increases both maternal and fetal circulation in ICP. The bile acids has been demonstrated to cause arrhythmia and abnormal calcium dynamics in cultured neonatal rat cardiomyocytes. Raised maternal bile acid levels have been associated with fetal distress and arrhytmia in fetus.

P-wave dispersion (PWD) is defined as the difference between the maximum and the minimum P-wave durations measured on a 12-lead surface electrocardiogram (ECG). Increased P-wave duration and PWD have been reported in various clinical settings, including atrial flutter, coronary artery disease, hypertension, rheumatic mitral stenosis, mitral annular calcification, obstructive sleep apnea, and obesity.

So the investigators think that bile acids may alter maternal cardiomyocyte function as fetus. The investigators hypothesized that PWD and p wave duration may affect in pregnancy with ICP.

The aim of this study is to investigate maternal P-wave duration and dispersion changes in pregnant women with intrahepatic cholestasis of pregnancy .

Eligibility criteria: Inclusion Criteria:

- Pregnants who with ICP

Exclusion Criteria:

* Chronic liver disease
* Disease during current pregnancy
* Multiple pregnancies

Primary outcomes:
measure: change in the range of P-wave Duration and Dispersion
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital
Study officials:
affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
name: ayse kirbas, md
role: PRINCIPAL_INVESTIGATOR
affiliation: Yuksek Ihtisas Hospital
name: ozgur kirbas, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03423927: Benefits of an Intervention Combining Hypnosis and Self-care for Prostate Cancer Patients
Official title: Benefits of an Intervention Combining Hypnosis and Self-care for Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: Free University of Brussels
First posted: 2018-02-06
Enrollment: 46
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants who agree to participate in the intervention are assigned in the experimental group, whereas participants who do not agree to participate in the intervention, but agree to answer the questionnaires, are assigned in the control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to assess the impact of a group intervention combining self-hypnosis and self-care techniques on prostate patients' well-being. More specifically, the investigators want to investigate the effects of that intervention on sleep, fatigue and emotional distress of the patients.


Eligibility criteria: Inclusion Criteria:

* 18-years-old,
* ability to read, write and speak French
* prostate cancer diagnosis
* treatment with surgery and/or radiotherapy.

Exclusion Criteria:

* metastases
* cancer recurrence at the moment of inclusion
* major cognitive or psychiatric disorder.

Primary outcomes:
measure: Change in Fatigue
timeFrame: T0 (before the intervention) and T1 (after the intervention : 6 months later).
measure: Change in emotional distress
timeFrame: T0 (before the intervention) and T1 (after the intervention : 6 months later).
measure: Change in sleep difficulties
timeFrame: T0 (before the intervention) and T1 (after the intervention : 6 months later).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Liege
name: Marie-Elisabeth Faymonville
role: STUDY_DIRECTOR
References:
citation: Gregoire C, Nicolas H, Bragard I, Delevallez F, Merckaert I, Razavi D, Waltregny D, Faymonville ME, Vanhaudenhuyse A. Efficacy of a hypnosis-based intervention to improve well-being during cancer: a comparison between prostate and breast cancer patients. BMC Cancer. 2018 Jun 22;18(1):677. doi: 10.1186/s12885-018-4607-z.
Clinical trial NCT03694327: Innovative Digital Therapeutic for Smoking Cessation
Official title: Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Nicotine Addiction
Drug Addiction
Drug Dependence
Tobacco Dependence
Tobacco Use Disorder
Substance Use Disorder
Tobacco Smoking
Lead sponsor: My Digital Study
Sponsor class: INDUSTRY
First posted: 2018-10-03
Enrollment: 158
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: This study is comparing the efficacy of two smoking cessation apps.

Detailed description: Given that tobacco smoking is the leading cause of preventable death in the US, the development of effective cessation programs is critical; mobile phone applications represent a novel, accessible platform for helping smokers quit. This research project seeks to compare the efficacy of two smoking cessation apps. In a blinded, randomized, controlled study, current smokers motivated to quit will use a smoking cessation app for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Male or female age 18 to 65
* Fluent in written and spoken English (confirmed by ability to read and comprehend Informed Consent Form)
* Lives in the United States
* Smokes at least 5 cigarettes daily
* Is interested in quitting in the next 30 days
* The participant owns and has access to an iPhone with iOS 9 or greater capabilities, or an Android with OS 7 or greater capabilities
* The participant is willing and able to receive SMS text messages on their smartphone
* The participant is willing and able to receive email messages.
* Ability to confirm download of installed treatment arm app via telephone on randomization date.
* One half of the study sample will be recruited from the general population of smokers via social media advertisements
* One half of the study sample will be recruited via mail form a Magellan Behavioral Health value-based care network

Exclusion Criteria:

* Prior use of Treatment A Digital Intervention or Treatment B Digital Intervention
* Current use of pharmacotherapy for smoking cessation or nicotine replacement therapy (NRT)

Primary outcomes:
measure: 30-Day Sustained Abstinence From Smoking
timeFrame: Upon completion of 8-week period
Secondary outcomes:
measure: Feasibility of Biochemical Verification of Smoking Cessation
timeFrame: Upon completion of 8-week period
measure: NRT and Smoking Cessation Pharmacotherapy Use
timeFrame: Upon completion of 8-week period
Other outcomes:
Locations:
city: New York
country: United States
facility: My Digital Study
state: New York
Study officials:
affiliation: My Digital Study
name: Brian M Iacoviello, PhD
role: PRINCIPAL_INVESTIGATOR
References: