louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01436617: Assessing the Value of a Dosage of Anti-cetuximab in the Therapeutic Management of Patients With Colon Cancer or Upper Aero-digestive Tract and Candidates for Treatment With Cetuximab
Official title: Assessing the Value of a Dosage of Anti-cetuximab in the Therapeutic Management of Patients With Colon Cancer or Upper Aero-digestive Tract and Candidates for Treatment With Cetuximab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Head and Neck Cancer
Allergic Reaction
Keywords: cancer
colon
Head and neck
cetuximab
anti-cetuximab dosage
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: University Hospital, Caen
First posted: 2011-09-19
Enrollment: 303
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 colon cancer or upper aero-digestive tract and candidates for treatment with cetuximab

Brief summary: The main objective of this study is to validate the utility of IgE anti-cetuximab in the treatment strategy to identify patients at risk for a severe allergic reaction to cetuximab (grade 3 or 4 of the classification of NCI) and thus reduce the incidence of severe reactions.


Eligibility criteria: Inclusion Criteria:

* Patient informed consent,
* Patient aged over 18 years
* Patients with a WHO performance status ≤ 2,
* Colon cancer or upper aero-digestive tract cytologically or histologically proven
* Patients with an indication to the theoretical use of cetuximab for colon neoplasia or upper aero-digestive tract,
* Haematological and biochemical compatible with combination therapy with cetuximab.

Exclusion Criteria:

* Patients previously treated with cetuximab,
* A person deprived of liberty or under supervision.

Primary outcomes:
measure: Validate the utility of an IgE anti-cetuximab test in the treatment strategy
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU
city: Bayeux
country: France
facility: Centre hospitalier
city: Caen
country: France
facility: CHU
city: Caen
country: France
facility: Centre François Baclesse
city: Dijon
country: France
facility: Centre Georges-François Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: CHRU Lille
city: Rouen
country: France
facility: CHU Charles Nicolle
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Strasbourg
country: France
facility: Centre Paul Strauss
Study officials:
affiliation: Centre François Baclesse
name: GERVAIS Radj, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03555617: Food-effect, Drug-Drug Interaction (DDI), and Formulation Bridging Study
Official title: A Phase 1, Open-Label, 2-Cohort Study to Assess the Single Dose Pharmacokinetics of Two Formulations of TD-1473 and to Assess the Effect of a High-Fat Meal and Itraconazole on the Pharmacokinetics of TD-1473 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammatory Bowel Disease
Keywords: healthy volunteers
drug-drug interaction
itraconazole
CYP3A
P-gp
Inflammatory Bowel Disease
IBD
Irritable Bowel Syndrome
IBS
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2018-06-13
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a Phase 1, open-label, 2-cohort, food-effect, DDI, and formulation bridging study.


Eligibility criteria: Inclusion Criteria:

* Male or female between 18 to 55 years old
* Male subjects must abstain from sexual intercourse or use a highly effective method of birth control
* Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control
* Body Mass Index (BMI) 18 to 32 kg/m2
* Willing and able to give informed consent
* Additional inclusion criteria apply

Exclusion Criteria:

* Planning to conceive a child during the study or within 2 months after the last dose of study drug
* Is positive for hepatitis A, B or C, and/or HIV
* Has clinically significant abnormalities in baseline laboratory evaluations
* Subject has a clinically significant abnormal electrocardiogram (ECG)
* Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening or is currently participating in another trial of an investigational drug (or medical device)
* Additional exclusion criteria apply

Primary outcomes:
measure: Maximum observed concentration (Cmax) in Plasma
timeFrame: Up to 8 days post-dose
measure: Time to maximum observed concentration (tmax) in Plasma
timeFrame: Up to 8 days post-dose
measure: Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma
timeFrame: Up to 8 days post-dose
measure: Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma
timeFrame: Up to 8 days post-dose
measure: Apparent terminal elimination half-life (t1/2) in Plasma
timeFrame: Up to 8 days post-dose
measure: Apparent clearance (Cl/F) in Plasma
timeFrame: Up to 8 days post-dose
measure: Apparent volume of distribution (Vz/F) in Plasma
timeFrame: Up to 8 days post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03415217: Neighbourhood Team Development (NTD) Program
Official title: Neighbourhood Team Development (NTD) Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Homes
Quality of Health Care
Lead sponsor: Conestoga College
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the implementation and the effects of the Neighbourhood Team Development (NTD) Program, an innovative multi-component program that aims to provide resident centred care in long term facilities (LTC). As Canadians age, there is an increasing demand for LTC services. Older people residing in LTC homes and their families expect excellent care and services. However, literature and anecdotal evidence clearly indicate that LTC is not necessarily resident and family centred, nor are the care providers always collaborating as a team, thereby compromising the residents' quality of life.1-5 Residents with Alzheimer's Disease or Related Dementias (ADRD), who may have difficulty voicing their concerns, are at particular risk of receiving poor resident centred care.6,7 Decisions such as mealtimes in large dining rooms or early bedtimes are seldom in line with the residents' needs or wishes and add to the growing concern that the current LTC system is ill-designed and outdated. The NTD Program, designed by the investigators, aims to both enhance team development and resident centredness in LTC. The Program has three components, designed to modify the physical environment, the organization and delivery of services, and the alignment of staff members, to function independently and collaboratively in providing resident-centred care.


Eligibility criteria: * Long-stay resident, family member, or staff member in Schlegel Villages (chain of long-term care homes in Ontario, Canada)
* Able to obtain informed consent

Primary outcomes:
measure: The change in resident centredness (as assessed by the CARE Profile score) from baseline to 4 years
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Boscart VM, Sidani S, Ploeg J, Dupuis SL, Heckman G, Kim JL, d'Avernas J, Brown P. Neighbourhood Team Development to promote resident centred approaches in nursing homes: a protocol for a multi component intervention. BMC Health Serv Res. 2019 Dec 2;19(1):922. doi: 10.1186/s12913-019-4747-0.
Clinical trial NCT02463617: Impulsivity and Parkinson's Disease : a Neuropsychology With Magnetic Resonance Imaging Study
Official title: Impulsivity and Parkinson's Disease : a Neuropsychology With Magnetic Resonance Imaging Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to characterize the nature of impulsivity in Parkinson's Disease (PD).


Eligibility criteria: Inclusion criteria :

Early onset PD patients and late onset PD patients with siblings available PD patients with or without impulse control disorders Current or past treatment with dopamine agonists or levodopa PD patients without dementia Age \< 80 ans

Exclusion criteria :

Early onset PD patients and late onset PD patients without siblings available PD patients with dementia Age \> 80 years

Primary outcomes:
measure: Barratt Impulsiveness Scale
timeFrame: up to three months
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Pascal DERKINDEREN
city: Poitiers
country: France
facility: Chu de Poitiers
city: Rennes
country: France
facility: Marc VERIN
Study officials:
affiliation: Poitiers University Hospital, France
name: Jean-Luc HOUETO, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01372917: Evaluating AlloMax in Immediate Expander-Based Breast Reconstruction Study
Official title: Evaluating Sterile Human Acellular Dermal Matrix in Immediate Expander-Based Breast Reconstruction: A Multi-centered Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Neoplasm of the Breast
Acquired Absence of the Breast
Lead sponsor: National Center for Plastic Surgery, Virginia
Sponsor class: OTHER
Collaborators: name: Inova Health Care Services
name: Ohio State University Comprehensive Cancer Center
name: Walter Reed Army Medical Center
name: C. R. Bard
First posted: 2011-06-14
Enrollment: 39
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients who opt for immediate breast reconstruction with tissue expanders from clinic.

Brief summary: The study is a prospective multi-centered cohort study designed to determine the safety and efficacy of AlloMax in immediate expander-based breast reconstruction. Specifically, the study is designed to determine if sterility of human acellular dermal matrix results in a lower incidence of infection and seroma. The study will determine if gamma radiation, as a method of terminally sterilizing human acellular dermal matrix, has a negative impact on graft incorporation into the host tissue.


Eligibility criteria: Inclusion Criteria:

* Patients having immediate breast reconstruction with tissue expanders
* Unilateral or bilateral reconstructions
* Ages 25 - 65
* All breast cancer stages and types

Exclusion Criteria:

* BMI \> 35
* Active smokers
* Diabetics
* History of radiation or planned radiation
* Immunocompromised patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: McLean
country: United States
facility: National Center for Plastic Surgery
state: Virginia
Study officials:
References:
citation: Venturi ML, Mesbahi AN, Boehmler JH 4th, Marrogi AJ. Evaluating sterile human acellular dermal matrix in immediate expander-based breast reconstruction: a multicenter, prospective, cohort study. Plast Reconstr Surg. 2013 Jan;131(1):9e-18e. doi: 10.1097/PRS.0b013e3182729d4f.
Clinical trial NCT01185717: JC-virus (JCV) Epidemiology in Multiple Sclerosis (MS)
Official title: Epidemiology of Anti-JCV Antibody Prevalence in Multiple Sclerosis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2010-08-20
Enrollment: 7726
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple Sclerosis (MS) patients will be enrolled in Europe, Canada, and Australia.

Patient enrollment from each country will be commensurate with the distribution of MS patients among all participating countries.

Brief summary: The objective of the study is to estimate the prevalence of anti-JCV antibodies in multiple sclerosis (MS) participants.

Detailed description: This is a cross-sectional, multi-center, multi-national, epidemiological study to estimate the prevalence of anti-JCV antibody in MS participants. This study will provide an estimate of the prevalence of anti-JCV antibody in the MS population and will investigate inter-country differences.

Eligibility criteria: Key Inclusion Criteria:

* All candidates for this study must have the ability to understand the purpose of the study and provide signed and dated informed consent.
* All patients with a diagnosis of Multiple Sclerosis (MS) of any type, irrespective of their treatment, are eligible to participate once.

Key Exclusion Criteria:

* None

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Prevalence of anti-JCV antibodies
timeFrame: Single timepoint (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: da Silva AM, Santos ME; Portuguese JEMS Study Investigators. JCV epidemiology in MS (JEMS)--epidemiology of anti-JCV antibody prevalence in multiple sclerosis patients--Portuguese data. J Neurol Sci. 2014 Feb 15;337(1-2):119-22. doi: 10.1016/j.jns.2013.11.031. Epub 2013 Dec 1.
Clinical trial NCT04929717: Social Media and Breastfeeding Self Efficacy
Official title: The Effect of Social Media Based Support on Breastfeeding Self-efficacy of Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: breastfeeding self-efficacy
breastfeeding support
social media
WhatsApp
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to determine the effect of breastfeeding support on women's breastfeeding self-efficacy via social media. This study was conducted maternity unit at a state hospital in Turkey. Education and consulting about breastfeeding were given via WhatsApp application to women in the intervention group. Women in the control group receive only routine breastfeeding training.

Detailed description: The research was conducted as a randomized controlled trial. The stratified and permutation block randomization methods were used in the study. The personal information form and BSES-SF were administered to women in the hospital before the intervention. Breastfeeding education and counseling were provided via social media (WhatsApp) to support women for breastfeeding and to ensure the continuity of breastfeeding in the postpartum period. Breastfeeding education was given to women in the first four weeks after discharge from the hospital. The control group received the routine breastfeeding postpartum educational training given to all women by healthcare personnel as part of the hospital procedures. Except for routine breastfeeding training, no intervention was applied to the control group.

Eligibility criteria: Inclusion Criteria:

* being primipara
* being 18 years of age or older
* using the WhatsApp social media application
* having a newborn with a weight of 2500 grams and above
* agreeing to participate in the study

Exclusion Criteria:

* being multiparity
* having a physical or mental health problem that would prevent breastfeeding
* preterm labor (before 37 weeks)
* difficult labor
* either mother or baby having a health problem after birth
* mother's substance use (drug, smoking or alcohol)

Primary outcomes:
measure: The Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)
timeFrame: Baseline
measure: The Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)
timeFrame: 3rd month
measure: The Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)
timeFrame: 6th month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University
name: Sultan Ayaz-Alkaya, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01495117: Study of Chlorhexidine Gluconate as a Preoperative Antisepsis
Official title: Comparison of Chlorhexidine Gluconate and Povidone Iodine as a Preoperative Antisepsis in Clean-contaminated Abdominal Surgery : a Randomized Prospective Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgical Site Infection
Keywords: surgical site infection
chlorhexidine gluconate
povidone iodine
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2011-12-19
Enrollment: 534
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine which drug (chlorhexidine gluconate vs. povidone iodine) as a preoperative antisepsis in clean-contaminated abdominal surgery (liver, hepatobiliary, small or large bowel, stomach) is effective.


Eligibility criteria: Inclusion Criteria:

1. Resection of following organs (clean-contaminated open surgery)

   * Liver, Pancreas, Bile duct, Duodenum
   * Stomach
   * Colon, Small bowel
2. Aged 20 - 85 years old
3. Use Prophylactic antibiotics
4. Use Preoperative bowel preparation
5. Elective operation
6. ASA classification 1-2 ASA I : no known systemic disease ASA II : single systemic disease \& mild or well controlled ASA III : multiple systemic diseases or moderately controlled systemic disease ASA IV : poorly controlled systemic diseases
7. adequate organ functions defined as indicated below:

   * WBC 3000 \~ 12 000/mm3
   * \> Hb 8.0 g/dl
   * \> Plt 100 000/mm3
   * \< Cr 1.2 mg/dl

Exclusion Criteria:

1. allergy to chlorhexidine or povidone
2. clean surgery or contaminated surgery
3. patients who cannot be followed up during 1 month
4. patients taking immunosuppressant drugs or chemotherapy agents
5. emergent surgery and reoperation
6. uncontrolled diabetes, BMI \> 30 kg/m2
7. vulnerable patients

Primary outcomes:
measure: Number of patients with Surgical Site infection within 1month
timeFrame: within 1 month
Secondary outcomes:
measure: Identify the infection source
timeFrame: within 1month
measure: Number of patients with Drug Side effect.
timeFrame: Within 1 month
measure: Number of patients with the postoperative sepsis induced by wound infection
timeFrame: within 1 month
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center, Republic of Korea
state: Gyeonggi-do
Study officials:
affiliation: Liver Cancer Center, National Cancer Center, Republic of Korea
name: Sung-Sik Han, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park HM, Han SS, Lee EC, Lee SD, Yoon HM, Eom BW, Kim SH, Ryu KW, Park SJ, Kim YW, Park B. Randomized clinical trial of preoperative skin antisepsis with chlorhexidine gluconate or povidone-iodine. Br J Surg. 2017 Jan;104(2):e145-e150. doi: 10.1002/bjs.10395. Epub 2016 Nov 23.
Clinical trial NCT04855617: Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis
Official title: Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2021-04-22
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving Multiple Sclerosis care at the NYU Comprehensive MS Care Center or the Elliot Lewis MS Center will be recruited. A clinical list of patients currently receiving ocrelizumab, or potentially starting ocrelizumab will be screened for study inclusion/exclusion criteria.

Brief summary: This study is designed to determine whether symptom burden differs by time to infusion.


Eligibility criteria: Inclusion Criteria:

* Age 18-80
* Diagnosis of multiple sclerosis (revised 2017 criteria)
* EDSS 0-7
* Plans to initiate treatment with ocrelizumab within 6 months or has been on an approved regimen of ocrelizumab for \>12 months as part of their clinical care
* Individual must be able to provide consent, read/write/comprehend English Language

Exclusion Criteria:

* Clinical relapse within 3 months of first on-study infusion
* Cognitive impairment limiting the ability to consent or fill out the electronic survey
* Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding
* Untreated psychiatric illness (such as major depressive disorder, Bipolar disorder, psychotic disorder, schizophrenia)
* Active substance abuse disorder
* Significant medical comorbidities (such as history of severe traumatic brain injury, stroke, systemic cancer or chronic infection)
* Chemotherapy use within 6 months of first study infusion
* Prior treatment with alemtuzumab within 12 months of first study infusion
* Prior treatment with a B-cell depleting therapy other than ocrelizumab within 12 months of first on-study infusion

Primary outcomes:
measure: Change in Quality of Life in Neurologic Disorders (NeuroQoL) Scores
timeFrame: Week 4, Week 22
Secondary outcomes:
measure: Change in SymptoMScreen (SyMS) Scores
timeFrame: Week 4, Week 22
measure: Change in Work Productivity and Activity Impairment Questionnaire: MS (WPAI:MS) Scores
timeFrame: Week 4, Week 22
Other outcomes:
Locations:
city: Wellesley
country: United States
facility: Elliot Lewis Center for Multiple Sclerosis Care
state: Massachusetts
city: New York
country: United States
facility: NYU Langone Health Multiple Sclerosis Comprehensive Care Center (NYULH MSCCC)
state: New York
Study officials:
affiliation: NYU Langone Health
name: Ilya Kister, MD
role: PRINCIPAL_INVESTIGATOR
References: