louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00998621: ADHEPTA Study: Adherence Questionnaire in Hepatitis C
Official title: Development and Validation of a Questionnaire Measuring Treatment Adherence in Patients With Hepatitis C
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
HIV Infection
Keywords: Hepatitis C, Chronic
HIV Infection
Medication Adherence
Questionnaire Design
Treatment experienced
Lead sponsor: Fundacion IMIM
Sponsor class: OTHER
First posted: 2009-10-20
Enrollment: 1120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HCV and with HCV + HIV

Brief summary: Main objective: To study and validate a questionnaire measuring treatment adherence in patients with Hepatitis C virus (HCV) infection.

Design of the study: Multicentric, prospective, epidemiological study in the field of usual clinical practice.


Eligibility criteria: Inclusion Criteria:

* Ambulatory patient infected by HCV according to diagnosis criteria used en usual clinical practice.
* Patient no treated previously and beginning a treatment for HCV.
* Patient that signed the informed consent to participate in the study.
* Group A: patient with HCV monoinfection.
* Group B: patient with HCV and HCV co-infection (according to diagnosis criteria used en usual clinical practice).

Exclusion Criteria:

* Patient that received previous treatment for HCV.
* Patient that is going to participate in a clinical trial Turing the HCV treatment period.
* Patient with cognitive impairment or patient unable to understand and answer the auto-administered questionnaire.
* Patient unable to read or write Spanish.

Primary outcomes:
measure: Main objective of the study is the development and validation of a Questionnaire measuring treatment adherence in patients with HCV infection.
timeFrame: 2 years
Secondary outcomes:
measure: Adherence will be measured according to 80/80/80 rule.
timeFrame: 2 years
measure: Establish a relationship between adherence, virological response (VR) and Sustained virological response (SVR).
timeFrame: 2 years
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
References:
Clinical trial NCT06552221: Finistere Myeloma Observatory (OMYFIN)
Official title: Finistere Myeloma Observatory: Retrospective Study of Chromosome 1 Abnormalities and Prognostic Value of a CKS1B (on 1q21)/CDKN2C (on 1p32) Copy Number Ratio in Myeloma.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive symptomatic multiple myeloma patients seen and treated i Hematology Department at Brest University Hospital from January 1, 2012 whose CKS1B/CDKN2C copy number ratio at diagnosis is calculable.

Brief summary: Current molecular risk stratification of multiple myeloma (MM), based on the presence of t(4 ;14) and 17p deletion, cannot fully explain treatment outcome heterogeneity, as other features also predict prognosis. About 30% of genetic events map to chromosome 1 : most upregulated genes to 1q and most downregulated ones to 1p. CKS1B gains on 1q21 and CDKN2C loss on 1p32, both favoring cell cycle progression, portended impaired outcome in many but not all studies. Based on their recurrence and considering their functional convergence, we hypothesized CKS1B/CDKN2C copy number ratio to be a risk factor fitter than each aberration alone.

Detailed description: This single-center retrospective study, is designed to enroll all consecutive newly diagnosed adult patients aged ≥18 years, transplant-eligible and not. All patients are routinely tested for CKS1B and CDKN2C and treated according to consensus guidelines. Data are being collected from 2012. For each subject, we calculate a FISH-based ratio by CKS1B on CDKN2C copy number : it is equal to 1 with no change in copy number and \>1 in case of CKS1B gains, CDKN2C loss or both. In patients with CDKN2C biallelic loss, the ratio is not equal to 0, but to CKS1B copy number, as functional consequence should prevail over arithmetic result. We will, then, analyze separately the impact of CKS1B gains, CDKN2C loss and CKS1B/CDKN2C ratio on PFS and OS.

Eligibility criteria: Inclusion Criteria:

* Age at or over 18 years
* Symptomatic multiple myeloma
* Informed consent given
* FISH-based cytogenetic results obtained

Exclusion Criteria:

* Age under 18 years
* MGUS or SMM
* No informed consent
* No FISH-based cytogenetic results

Primary outcomes:
measure: Response rate
timeFrame: 10 years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 10 years
Other outcomes:
measure: Overall survival (OS)
timeFrame: 10 years
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: CHU de Brest
name: Jean-Richard Eveillard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02041221: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPARC1316
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Asthma
Keywords: pharmacokinetics, pharmacodynamics, asthma
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2014-01-20
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sun Pharma Advanced Research company Limited has developed a dry powder inhaler of compound SPARC1316 for oral inhalation. This clinical study is a Phase I/IIa study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of S0597 administered by oral inhalation to healthy volunteers and asthma patients.


Eligibility criteria: Inclusion Criteria:

* Subjects willing to provide informed consent
* Male or female subjects aged 18 to 65 years inclusive
* Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive
* Non-smokers or ex-smokers

Exclusion Criteria:

* Subjects with a supine systolic blood pressure ≥160 mmHg and/or a supine diastolic blood pressure ≥100 mmHg
* Subjects who have a significant infection or known inflammatory process on screening or admission.
* Subjects who are unlikely to co-operate with the requirements of the study.
* Positive serology for infectious disease (hepatitisB or C , HIV) at screening

Primary outcomes:
measure: Number of Subjects With Adverse Events
timeFrame: Two (2) Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: SPARC study site
Study officials:
References:
Clinical trial NCT00308321: Long Term Tapering or Standard Steroids for Nephrotic Syndrome
Official title: Long Term Tapering or Standard Steroids for Nephrotic Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Nephrotic Syndrome
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
First posted: 2006-03-29
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Parallel group double blind randomised in patients with first episode corticosteroid sensitive nephrotic syndrome comparing time to relapse and adverse effects associated with a longer tapering steroid regimen with standard regime


Eligibility criteria: Inclusion Criteria:

* newly presenting nephrotic syndrome, urine albumin/protein creatinine ratio \>200mg/mmol on early morning urine sample, hypoalbuminemia (\<25g/L)

Exclusion Criteria:

* prior treatment with steroids or cytotoxic agents underlying systemic disorder or exposure to agents known to be associated with newly presenting steroid sensitive nephrotic syndrome

Primary outcomes:
measure: Time to first relapse
timeFrame: 5 months
measure: Assessment of steroid induced morbidity
timeFrame: 5 months
Secondary outcomes:
measure: frequent relapsing and steroid dependant disease
timeFrame: 5 months
measure: Time to relapse
timeFrame: 5 months
measure: serious adverse events
timeFrame: 5 months
measure: use of other immunosuppressive agents
timeFrame: 5 months
measure: Achenbach child behaviour checklist
timeFrame: 5 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Institute of Child Health
Study officials:
affiliation: Great Ormond Street Hospital
name: Richard Trompeter
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital, Leicester
name: Peter Houtman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02656121: Correction of Vitamin D Deficiency and Its Effect on Ovulation Induction in Women With PCOS (VIDEO): A Feasibility RCT
Official title: Correction of Vitamin D Deficiency and Its Effect on Ovulation Induction in Women With PCOS (VIDEO): A Feasibility RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: PCOS
Keywords: PCOS, vitamin D
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recently, a special emphasis has recently been directed to the potential role of vitamin D and some regulatory peptides (e.g. adipokines and follistatin) and their associated metabolic roles and genetic factors in the development of PCOS and its related co-morbidities. The aim of this study was to assess the feasibility of conducting a pragmatic RCT assessing the effectiveness of adopting a protocol of screening for and correcting Vitamin D deficiency in women with PCOS seeking fertility treatment in a low/middle income care (LMIC) setting

Detailed description: Research question:

In PCOS patients, is there any effect of vitamin D testing and correction on ovulation induction in women with PCOS?

Research hypothesis:

There is effect of testing and correcting vitamin D status as regard ovulation in patients with PCOS

Eligibility criteria: Inclusion Criteria:

* diagnosed PCOS cases according to the National Institute of Health criteria (NIH consensus criteria) and Rotterdam criteria

Exclusion Criteria:

* 1- PCOS patients not in child bearing age; less than 18 years or more than 45 years.

  2- Patients with congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia and virilizing ovarian or adrenal tumors.

  3- PCOS patients with any other medical illness. 4- PCOS patients already on vitamin D supplements.

Primary outcomes:
measure: cumulative clomiphene citrate-induced ovulation rates
timeFrame: 6 months
Secondary outcomes:
measure: Cumlative clinical pregnancy rate
timeFrame: 6 months
measure: median ovulating dose of clomiphene citrate
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Ain Shams University
state: Al Qahirah
Study officials:
affiliation: Ain Shams University
name: Ahmed M kotb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02601521: Comparative Effectiveness of Two Tobacco Cessation Interventions for Employees of Partners HealthCare, Inc.
Official title: Comparative Effectiveness of Two Tobacco Cessation Interventions for Employees of Partners HealthCare, Inc.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Tobacco Use Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Partners HealthCare, Inc.
First posted: 2015-11-10
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Specific Aim: To conduct a randomized controlled trial among permanent employees of Partners HealthCare, Inc., and their adult dependents, who are current tobacco smokers. The trial will compare two interventions designed to help smokers stop using tobacco: (1) External Coaching Program (Standard Care) and (2) Internal Coaching Program, a chronic disease management strategy for treating tobacco use and dependence.


Eligibility criteria: Inclusion Criteria:

* Current permanent employee of Partners Healthcare, Inc. or their adult dependent
* Current tobacco smoker (smoked a cigarette, even a puff, in the past 30 days)

Exclusion Criteria:

* Temporary, per diem or former employee of Partners Healthcare, Inc.
* Plan to leave Partners employment in the next 12 months
* Inability to give informed consent or participate in counseling due to serious psychiatric disorder or cognitive disorder

Primary outcomes:
measure: Tobacco abstinence for the past 30 days
timeFrame: 6 months after enrollment
Secondary outcomes:
measure: Tobacco abstinence for the past 30 days
timeFrame: 3 months after enrollment
measure: Tobacco abstinence for the past 30 days
timeFrame: 12 months after enrollment
measure: Quit attempt
timeFrame: Intentional tobacco abstinence for at least 24 hours since enrollment
Other outcomes:
measure: Duration of use of tobacco cessation pharmacotherapy
timeFrame: at 3 months and at 6 months after enrollment
measure: Smoking cessation counseling contacts
timeFrame: at 3 months and at 6 months after enrollment
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Nancy A Rigotti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00573521: Risk Factors for Piperacillin/Tazobactam Resistance in Extended-Spectrum Beta-Lactamase (ESBL) Producing Organisms
Official title: Risk Factors for Piperacillin/Tazobactam Resistance in Extended-Spectrum Beta-Lactamase (ESBL) Producing Organisms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enterobacteriaceae Infections
Keywords: ESBL positive cultures
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2007-12-14
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ESBL positive cultures

Brief summary: This research will be conducted to determine whether risk factors exist for piperacillin/tazobactam resistance in ESBL organisms.

Detailed description: This is chart review at UPMC. NO human subject interaction will occur.

Eligibility criteria: Inclusion Criteria:

* Clinical information is collected by chart review of "case" and "control" patients.
* A "case A" patient is defined as follows: One or more clinical cultures are positive for an ESBL producing bacteria and the organism is piperacillin/tazobactam resistant.
* A "case B" patient is defined as follows: One or more clinical cultures are positive for an ESBL producing bacteria and the organism is piperacillin/tazobactam susceptible.
* Additionally, 1 control patient in the hospital at the same time as the case patients will be randomly selected for each case and are not in either case group.

Exclusion Criteria:

* Patients \< 18 years of age

Primary outcomes:
measure: This research will help to identify risk factors for resistance to an antibiotic that is commonly used in the empiric treatment of critically ill patients.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Brian Potoski, Pharm D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01054521: A Randomized Study of Temperature-controlled and Bipolar Radiofrequency for Inferior Turbinate Reduction
Official title: A Randomized Comparison Study of Temperature-controlled and Bipolar Radiofrequency for Inferior Turbinate Reduction in Patients With Chronic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Chronic Rhinitis Who Failed Medical Treatment
Keywords: radiofrequency turbinate reduction
nasal obstruction
Temperature-controlled radiofrequency
Bipolar radiofrequency
chronic rhinitis.
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2010-01-22
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Currently, there are several alternative treatments for patients with chronic rhinitis (CR) who failed medication. Although, most of the researches have been focusing on temperature-controlled RF (TCRF), the cost is a major limitation for applying it worldwide. The investigators objective of this study is to compare the subjective and objective outcomes of Bipolar RF (BRF) with the more popular TCRF for CR treatment. The investigators hypothesized that both have equivalent outcomes but with less operative time and potentially at lower cost.


Eligibility criteria: Inclusion Criteria:

* Adults with snoring and chronic nasal obstruction.
* Respond to topical decongestant but not respond to nasal steroids, oral anti-histamine and oral decongestant
* Consent to the protocol.

Exclusion Criteria:

* Chronic active sinusitis, severe Deviated nasal septum (DNS), nasal polyps, sinonasal tumor, previous sinonasal surgery or head neck irradiation.
* Uncontrolled bleeding disorders, hypertension, or cardiovascular diseases
* Not complete the protocol

Primary outcomes:
measure: Visual Analog scale scores of nasal obstructive symptom.
timeFrame: Up to 1 year follow-up
Secondary outcomes:
measure: VAS scores of nasal discharge, sneezing, hyposmia, postnasal drip
timeFrame: Up to 1 year follow-up
measure: Postoperative crust, mucociliary transportation time (MTT), minimal cross sectional area (MCA), total nasal volume (VOL), nasal airway resistance (NAR) at 75 Pa
timeFrame: Up to 1 year follow-up
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: Wish Banhiran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Banhiran W, Assanasen P, Tantilipikorn P, Nujchanart N, Voraprayoon S, Bunnag C. A randomized study of temperature-controlled versus bipolar radiofrequency for inferior turbinate reduction. Eur Arch Otorhinolaryngol. 2015 Oct;272(10):2877-84. doi: 10.1007/s00405-014-3410-y. Epub 2014 Nov 29.
Clinical trial NCT02344121: Intra- and Inter-fraction Changes in Radiation Therapy
Official title: Intra- and Inter-fraction Changes in Radiation Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2015-01-22
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients who have completed treatment.

Brief summary: Analysis to quantify intra-fraction, inter-fraction and post-treatment changes in tumor target volumes and surrounding normal organs in radiation therapy.

Detailed description: The accurate and detailed knowledge of the changes (e.g., anatomically/biologically intra- and inter-fraction changes) to be obtained from this study would allow the research team to determine how Adaptive Radiation Therapy (ART) should be performed for a given tumor site/type. Radiation oncologists then can choose a proper ART strategy for a given tumor type to account for the anatomic/biological intra- and inter-fraction changes, improving accuracy of radiation therapy delivery, and in turn reducing treatment related toxicities and/or improving tumor local control.

Eligibility criteria: Inclusion Criteria:

°Completed radiation therapy

Exclusion Criteria:

°Subjects who refuse voluntary participation

Primary outcomes:
measure: Changes of volumes from baseline of organs at risk during and after radiation therapy.
timeFrame: 2 years
Secondary outcomes:
measure: Changes of volumes from baseline or tumors during and after radiation therapy.
timeFrame: 2 years
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Eric Paulson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01878721: Positron Emission Tomography of Infection and Vasculitis
Official title: Positron Emission Tomography of Infection and Vasculitis (PETU)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Vasculitis
Keywords: PET/CT
infection
vasculitis
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2013-06-17
Enrollment: 117
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 of Turku University Hospital

Brief summary: The purpose of this study is to evaluate the value of positron emission tomography/computed tomography in various inflammatory conditions caused by bacterial infection or vasculitis. Glucose analog FDG is sensitive to detect inflammation foci but we hypothesize that other imaging agents such as PK11195 and Ga-citrate may have added value in certain applications.

Detailed description: The purpose of this study is to evaluate the value of PET/CT in various inflammatory conditions caused by bacterial infection or vasculitis. Our aim is to:

1. investigate whether FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) PET/CT and 68Ga-(Gallium-68) citrate PET/CT enable the early and accurate detection of metastatic infection foci in Staphylococcus aureus bacteremia.
2. study the usefulness of FDG PET/CT in detection of endovascular infection in bacteremia caused by Salmonella spp.
3. find an optimal FDG PET/CT protocol for detection of infectious endocarditis and metastatic infection foci related to endocarditis.
4. study the value of FDG PET/CT in the diagnosis of infection of pacemaker or implantable cardioverter defibrillator.
5. investigate the usefulness of FDG PET/CT, 68Ga-citrate PET/CT, and 11C- (carbon-11) translocator protein ligand (PK11195) PET/CT in diagnosis of vasculitis and in imaging of the magnitude of the vascular changes.

Eligibility criteria: Inclusion Criteria:

Adults with

* Staphylococcus aureus bacteremia or
* Salmonella spp. bacteremia or
* infective endocarditis or
* infection of pacemaker or implantable cardioverter defibrillator or
* vasculitis

Exclusion Criteria:

* underage, pregnant, breastfeeding, handicapped or prisoner

Primary outcomes:
measure: Detection of infection or vasculitis in PET images
timeFrame: within 1 week after starting the treatment
Secondary outcomes:
measure: Standardized uptake value of PET imaging agent at the site of infection or vasculitis
timeFrame: within 1 week after starting the treatment
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
References: