louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01406782: DNA Analysis in Influencing Response to Rituximab in Samples From Patients With Follicular Lymphoma Treated on ECOG-E4402
Official title: The Influence of KIR and HLA Genotype on the Response to Rituximab Immunotherapy in Patients With Follicular Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-08-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from patients enrolled on E4402 from whom samples were submitted for research

Brief summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is studying DNA isolated from blood samples to see how well it influences response to rituximab in patients with follicular lymphoma treated on clinical trial ECOG-E4402.

Detailed description: OBJECTIVES:

* To test the influence of killer immunoglobulin-like receptor (KIR) and human lymphocyte antigen (HLA) genotype on response to anti-CD20 antibody lymphoma immunotherapy.

OUTLINE: DNA samples are analyzed for killer immunoglobulin-like receptor (KIR) and human lymphocyte antigen (HLA) genotyping with sequence-specific primers (SSP) by real-time PCR. KIR and HLA typing are analyzed according to KIR-HLA matched vs mismatched, KIR B haplotype content, and the number of inhibitory KIR-HLA pairs. Results are then correlated to each patient's overall response and duration of response to rituximab.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Patients diagnosed with follicular lymphoma enrolled on ECOG-E4402

  * Treated with single-agent rituximab; the trial compared two different rituximab-dosing strategies - maintenance vs retreatment as needed
* Available germline DNA samples isolated from peripheral blood as well as clinical evaluation of disease status prior to and at initial response to the therapy

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: KIR-HLA genotype predictive of antibody-dependent cell-mediated cytotoxicity (ADCC)-based cancer immunotherapy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Madison
name: Erik Ranheim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04724382: Healthy Eating Education for Latinos
Official title: Culturally-tailored Healthy Eating Education Intervention for Latinos in Massachusetts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Diet Habit
Obesity
Blood Pressure
Psychological
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 76
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This intervention aims to evaluate the efficacy of a pilot educational intervention with deep-structure cultural tailoring for Latino ethnic groups on diet quality compared to general, surface-level healthy-eating messages.


Eligibility criteria: Inclusion Criteria:

* Aged 25-65 y/o
* Self-reported Hispanic/Latino heritage
* Able to understand and answer questions in Spanish or English
* Living in the Boston, MA metro area for the past 6 months and not planning to move in the next 6 months
* Has a cellphone with the capacity of receiving text messages and gives consent for the Study to text this number as part of the intervention

Exclusion Criteria:

* Younger than 25y or older than 65y
* Not Hispanic/Latino heritage
* Has condition or impairment that affects mental, cognitive, or memory abilities; such as Alzheimer's disease or stroke
* Has been diagnosed with cancer, diabetes (type 1 or 2), heart condition, major stomach condition (examples: coronary heart disease, heart attack, stroke or stroke, allergies, or severe diet restrictions)
* Does not understand Spanish or English
* Pregnant
* Under the care of an institution
* Living in another state outside of Massachusetts or planning to move in less than 6 months
* No cellphone with text capabilities (or cannot be used to receive texts from the Study)

Primary outcomes:
measure: Changes in diet quality score
timeFrame: 4 months
measure: Changes in diet habits
timeFrame: 4 months
Secondary outcomes:
measure: Changes in diet satisfaction: diet satisfaction scale
timeFrame: 4 months
measure: Changes in attitude for eating: attitudes scale
timeFrame: 4 months
measure: Changes in reasons for eating: reasons scale
timeFrame: 4 months
Other outcomes:
measure: Changes in depression score: CESD
timeFrame: 4 months
measure: Change in levels of adipose risk factor
timeFrame: 4 months
measure: Change in levels of blood pressure risk factors
timeFrame: 4 months
measure: Changes in dysfunctional eating behaviors
timeFrame: 4 months
Locations:
city: Boston
country: United States
facility: Harvard TH Chan School of Public Health
state: Massachusetts
Study officials:
References:
Clinical trial NCT00525382: Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria
Official title: A Study Evaluating the Efficacy and Safety of 5 mg Levocetirizine Oral Tablets, Once Daily Versus 10 mg Loratadine Oral Tablets, Once Daily for the Treatment of Chronic Idiopathic Urticaria (CIU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urticaria
Keywords: Levocetirizine dihydrochloride
Xyzal tablets
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-09-05
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria.


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 to 60 years old (inclusive
* having chronic idiopathic urticaria
* at least 6-weeks history of CIU, had at least 3 days of wheals presence/week
* moderate to severe CIU defined as pruritus score ≥ 2, number of wheals ≥ 2, and total symptoms CIU score ≥ 2 at randomization

Exclusion Criteria:

* Asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn
* atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or dermal topical corticosteroids
* urticaria caused by physical factors or other known factors
* cholinergic urticaria
* had urticaria due to other systemic disorders
* were on antihistamine drug currently

Primary outcomes:
measure: pruritus severity, assessed by the investigator over 2 weeks of treatment
timeFrame: 2 weeks
Secondary outcomes:
measure: Symptom score reducing index; subject severity score at 1 and 2 weeks; investigator global evaluation after 2 weeks of treatment; safety
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05124782: Virtual Management of Rheumatoid Arthritis
Official title: Evaluation of Rheumatoid Arthritis at the Time of Telemedicine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Virtual consultation
Telemedicine
Patient reported outcome
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with rheumatoid arthritis followed in a tertiary center (University Hospital Cochin)

Brief summary: The purpose of this study is to optimize the care of patients with RA seen in virtual consultation.

Detailed description: This study will be organized in two consecutive steps:

1. A first descriptive step that will consist of a retrospective analysis of virtual consultation records of patients with RA during the pandemic and lockdown period in order to analyze on which criteria the patients were assessed and followed during this period.
2. The second step will consist in evaluating the interest of the systematic use in virtual consultation of a patient reported outcome (PRO), the RAID (Rheumatoid Arthritis Impact of Disease) questionnaire; and analyze how its results influence the rheumatologist decision-making.

Eligibility criteria: Inclusion Criteria:

* Patients with rheumatoid arthritis fulfilling the 2010 ACR/EULAR classification criteria
* Follow-up in the rheumatology department of Cochin Hospital
* Affiliated with a social security scheme
* Non-opposition to participating in the study
* Patients with a valid email address (registration to the virtual consultation system)

Exclusion Criteria:

* Opposition to participate to this research
* Inability to understand or speak French
* Patient under tutor or curator ship
* patients under medical state help

Primary outcomes:
measure: Rate of face to face consultation, hospitalization and therapeutic modifications
timeFrame: Inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Rheumatology Department, Cochin Hospital
state: IDF
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jérôme AVOUAC, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03034382: Morphine and/or Nalbuphine as Adjuvants in Ultrasound Guided Interscalene Block: for Shoulder Surgeries
Official title: Adjuvants to Ultrasonic Guided Interscalene Block In Arthroscopic Rotator Cuff Repair; Morphine and/or Nalbuphine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rotator Cuff Tear
Keywords: morphine
nalbuphine
arthroscopic rotator cuff repair
ultrasound guided interscalene block
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 80
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: PREVENTION

Brief summary: the aim of this study is to evaluate the duration of analgesia when either morphine or nalbuphine or both are used as adjuvants in sonar guided interscalene brachial plexus block for arthroscopic rotator cuff repair.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for arthroscopic repair of rotator cuff muscle tear of the shoulder.
* ASA physical status I - Ш.

Exclusion Criteria:

* Infection at the site of injection.
* Coagulopathy or other bleeding diathesis.
* Known allergy to drugs in the study
* Preexisting neurologic deficits in the area to be blocked.
* Inability to communicate with the investigator and the hospital staff.
* History of chronic opioid use.
* Morbid obesity BMI\>40.

Primary outcomes:
measure: the total number of analgesic requests
timeFrame: 72 hours postoperative followup
Secondary outcomes:
measure: duration of analgesia
timeFrame: 72 hours followup
measure: patient satisfaction
timeFrame: 72 hours followup
measure: The first time to ask for analgesics
timeFrame: 72 hours followup
measure: sedation score
timeFrame: 72 hours followup
measure: number of vomiting attacks
timeFrame: 72 hours followup
measure: itching
timeFrame: 72 hours followup
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospitals
Study officials:
affiliation: Assiut University Hospitals
name: Mahmoud A Aly, Prof
role: STUDY_CHAIR
affiliation: Assiut University Hospitals
name: Kawser H Mohammed, Prof
role: STUDY_CHAIR
affiliation: Assiut University Hospitals
name: Ayman A Mamdouh, Ass Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT01291082: Whole-body MR in Staging Bone and Soft Tissue Metastases in Breast Cancer Patients(MetaMaRBo)
Official title: Whole-body Magnetische Resonantie Voor Het Opsporen Van Bot- en Weke Delenmetastasen Bij patiënten Met Een Borstcarcinoom (MetaMaRBo)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Breast cancer
metastasis
bone
diffusion MRI
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-02-07
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer patients

Brief summary: Prospective MR-imaging study : role of magnetic resonance (MR) and Diffusion weighted imaging (DWI) MR in staging and therapy assessment in breast cancer patients with bone metastases.

Detailed description: About 50 patients with a proven breast cancer and bone metastases will be included.

First step : staging

* nuclear bone scan
* Positron Emission Tomography (PET/CT)
* MR (whole body short tau inversion recovery (STIR)-sequence and T1-sequence and Diffusion weighted imaging (DWI),no contrast administration

Aim :

* Validation of whole body diffusion weighted imaging in detection of bone metastases and visceral metastases, comparing to Bone scan en PET/CT results.
* To calculate cut-off values for DWI for bone and visceral metastases.

Second step : therapy follow-up/therapy assessment.

* Two groups of patients (oncologist takes the decision about therapy)

  1. Patients treated by chemotherapy
  2. Patients treated by hormonal therapy
* on week 3, 12-16 and 52 in the chemotherapy or hormonal therapy-setting, a whole body MR (same protocol, no contrast) will be performed.

End-point:

Whole body MR with DWI is useful and reliable to assess the treatment response.

Eligibility criteria: Inclusion Criteria:

1. Patients with a proven breast cancer (by biopsy or imaging)
2. Bone metastases proven by MR, PET-CT or Bone. Patients with visceral metastases can be included if bone metastases are also present.
3. Patient with an informed consent.

Exclusion Criteria:

1. Patients with a single bone metastasis treated by Radiotherapy will be excluded.
2. Patients with contra-indication for MRI: pacemaker, cochlear implant, non MR compatible devices (Baclofenpump).
3. Claustrophobia
4. Patient in a bad general condition.

Primary outcomes:
measure: Validation of whole body diffusion weighted MRI in breastcancer patients
timeFrame: 6 months
Secondary outcomes:
measure: Whole body MRI with diffusion weighted imaging is a reliable imaging tool for therapy assessment
timeFrame: 12 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: UZ Leuven Dept Radiology
name: Steven Pans, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02743182: HBsAg Loss Adding Pegylated Interferon in HBeAg-negative Patients
Official title: HBsAg Loss Adding Pegylated Interferon Alfa-2a in HBeAg-negative Patients Treated With Nucleos(t)Ide Analogues.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Hepatitis B (HBeAg-negative)
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2016-04-19
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Chronic hepatitis B (CHB) affects more than 350 million people worldwide. The most common form in Europe is CHB HBeAg-negative. Antiviral treatment of CHB HBeAg-negative patients includes chronic administration of nucleos(t)ide analogues (NUC) or pegylated interferon (PegIFN) during 12 months. Typically, PegIFN allows immune control of CHB and antigen "s" (HBsAg) loss in around 4% of patients compared to less than 0,1% using NUC. Recently, it has been described that HBsAg quantification (HBsAg-q) is useful to identify patients with high probability to lose HBsAg during follow-up. In addition, a proof-of-concept study with nine HBeAg-negative patients receiving NUC showed that adding PegIFN (16 weeks) achieved HBsAg loss in one patient (11%). The aim of our study is to evaluate the efficacy and safety adding PegIFN (48 weeks) in treated HBeAg-negative patients with NUC.


Eligibility criteria: Inclusion Criteria:

* Chronic hepatitis B (HBeAg-negative)
* Signed inform consent
* Aged \> 18

Exclusion Criteria:

* Contraindications for Pegylated interferon (cirrhosis, pregnancy, others)
* Previous treatment with interferon or Pegylated interferon
* Previous HBsAg loss
* Treatment duration with Nucleos(t)ide analogues less than 2 years
* Poor adherence to Nucleos(t)ide analogues

Primary outcomes:
measure: Number of patients with HBsAg loss
timeFrame: 1 year after treatment completion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00399620: Chromogranin-A-Derived Peptides and Periodontitis in Diabetic Patients
Official title: Chromogranin-A-Derived Peptides in the Gingival Crevicular Fluid and the Saliva of Diabetic Patients With or Without Periodontitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis and Diabetitis
Keywords: Periodontitis
Diabetes
Gingival crevicular fluid
GCF
Saliva
Chromogranin
Electrophorèse
Western Blot
RT-HPLC
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2006-11-15
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Periodontitis is a chronic disease of the supporting tissue of the teeth, characterized by bleeding and inflamed gingival, resorption of alveolar bone. This disease has a significant impact of the quality of life as the teeth become progressively mobile and may fall out spontaneously if no treatment is provided. Periodontal disease has been cited as the sixth complication of diabetes mellitus.Chromogranins / secretogranins are a family of proteins present in nervous endocrine and immune cells, released with catecholamines during stress situations. Chromogranin A (CGA) is the major member of this family.The aim of this study is to determine the level of CGA and its derived peptides in the gingival crevicular fluid (GCF) of health or diabetic patients with and without periodontitis.Then, we want to determine the antimicrobial activity of these peptides.


Eligibility criteria: Inclusion criteria:

* Patients from 20 to 80 years old
* A minimum of 10 teeth
* Healthy volunteers or diabetic patients with or without periodontitis

Exclusion criteria:

* a course of antibiotics
* a fungicidal therapy
* a corticotherapy
* a hormone therapy
* a pregnancy
* persons under guardianship

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Département de Parodontologie - Hôpital Civil
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Martine Soell, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02683720: Evaluating the Efficacy of a Novel Oral Supplement in Tackling Malnutrition in the Elderly
Official title: Evaluating the Efficacy of a Novel Oral Supplement in Tackling Malnutrition in the Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malnutrition
Muscle Health
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Vitalnext
First posted: 2016-02-17
Enrollment: 82
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: ProMO aims to investigate the effectiveness of a newly developed ONS in increasing body weight, muscle mass and function in malnourished elderly compared to standard care.


Eligibility criteria: Inclusion Criteria:

* age 65+
* at risk of malnutrition/ malnourished

Exclusion Criteria:

* • Mental status that is incompatible with the proper conduct of the study

  * Illness of such severity that life expectancy is considered to be less than 12 months
  * Use of diabetes medication (e.g. insulin, methformin)
  * Use of an oral nutritional supplement in the previous three months
  * Participating in any regular exercise training program (≥2h/w)
  * Renal insufficiency (eGFR \<30 mL/min/1.73 m2)
  * Unstable organ failure or organ failure necessitating a special diet
  * Chronic corticosteroids use
  * Recent (previous 2 months) use of antibiotics
  * Recent (previous 3 months) change in habitual medication use (e.g statins and thyroxin)
  * Recent blood donation (\<1 month prior to Day 01 of the study)
  * Not willing or afraid to give blood during the study
  * Allergic or sensitive for milk proteins
  * Reported vegan or macrobiotic life-style
  * Drug and/or alcohol abuse (current consumption of more than 21 alcoholic drinks per week)
  * Individual unable to give informed consent
  * Current participation in other research from the Division of Human Nutrition
  * Not having a general practitioner
  * Personnel of Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives

Primary outcomes:
measure: lean body mass
timeFrame: 12 weeks
Secondary outcomes:
measure: body weight
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University
Study officials:
References:
citation: Grootswagers P, Smeets E, Oteng AB, Groot L. A novel oral nutritional supplement improves gait speed and mitochondrial functioning compared to standard care in older adults with (or at risk of) undernutrition: results from a randomized controlled trial. Aging (Albany NY). 2021 Apr 2;13(7):9398-9418. doi: 10.18632/aging.202912. Epub 2021 Apr 2.