louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06796517: Immunotherapy in Lymphoma
Official title: Risk Factor Analysis Study for the Efficacy Comparison Between Advanced Immunochemotherapy and Classical Immunochemotherapy: a Prospective Study for Relapsed/Refractory Lymphoma Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Relapsed/refractory High Grade B Cell Lymphoma
High Grade B-cell Lymphoma
Diffuse Large B Cell Lymphoma Relapsed
Primary Mediastinal Large B-Cell Lymphoma
Burkitt Lymphoma
Keywords: immunochemotherapy
B cell lymphoma
Relapsed
Refractory
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Yeouido St. Mary's Hospital
First posted: 2025-01-28
Enrollment: 72
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from Seoul St. Mary hospital and Yeoido St. Mary hospital

Brief summary: The goal of this observational study is to compare the efficacy of advanced immunochemotherapy and classical immunochemotherapy in relapsed/refractory high grade B cell lymophoma patients. The main question it aims to answer is:

Does advanced immunochemotherapy, including CAR-T therapy, bispecific antibody, and antibody-drug conjugate offer superior survival outcomes than when treated with classical immunochemotherapy, such as proteasome inhibitors, immune modulatory drugs, and monoclonal antibodies?

Researchers will compare patients receiving advanced immunochemotherapy with those receiving classical immunochemotherapy to determine if advanced therapies result in better survival outcomes.

Laboratory findings and electronic medical records (EMR) from participants will be used to assess survival outcomes and treatment-related safety profiles.


Eligibility criteria: Inclusion Criteria:

* Adults aged 19 to 74 years.
* Diagnosed with any of the following after January 2015: diffuse large B cell lymphoma, primary mediastinal large B cell lymphoma, high grade B cell lymphoma, or Burkitt lymphoma
* Patients who have received immunochemotherapy as treatment for relapsed/refractory lymphoma

Exclusion Criteria:

* Patients who have progressed to acute leukemia
* Patients who developed solid tumor during treatment
* Patients with active infectious status (acute pneumonia, viral infection, active hepatitis B state, or active pulmonary tuberculosis etc.)

Primary outcomes:
measure: Overall survival
timeFrame: From the start of treatment or the date of study enrollment until death from any cause, assessed up to 100 months.
Secondary outcomes:
measure: Progression-free survival
timeFrame: From the start of treatment or the date of study enrollment until disease progression or death from any cause, whichever comes first, assessed up to 100 months.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary Hospital
city: Seoul
country: Korea, Republic of
facility: Yeoido St. Mary Hospital
Study officials:
References:
Clinical trial NCT01189617: Safety Study for an All-in-One Body and Personal Lubricant
Official title: A Single-center, Medically Supervised, Safety Evaluation Study of an All-in-One Body and Lubricant Product
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lubricating Agents
Keywords: Personal Lubricant
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2010-08-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This is a one-week study designed to test the safety of an all-in-one body and personal lubricant product during in-home use.

Detailed description: This is a single-center, medically supervised, single-arm study to evaluate the safety of an all over body and personal lubricant product in home-use conditions via clinical assessment. The study will consist of 2 visits. Subjects who meet the entrance criteria will receive investigational product (IP) and 2 subjective questionnaires for at-home completion. The subjects will be required to use the IP at least 2 times, as instructed over the 1-week home-use period. At the end of the study (visit 2) subjects will return to the study site, at which time the unused IP and questionnaires will be returned and a final clinical assessment will be performed.

Eligibility criteria: Inclusion Criteria:

* Normal, healthy adults in a stable, monogamous, ongoing heterosexual relationship with current partner within protocol-specified parameters
* Subjects comfortable discussing sensitive topics such as personal hygiene, menstruation and sexuality
* Able to read and understand English
* Voluntarily signs an Informed Consent document after the trial has been explained
* Willing to follow all study procedures, including birth control requirements

Exclusion Criteria:

* Any medical or mental health history or condition, or use of any product, drug or medication that per protocol (or in the opinion of the Investigator) might compromise the participant's safety or the analysis of results
* Participation as a research subject in a different trial within timelines dictated by protocol
* Participants with relationships or employment outside protocol-defined parameters

Primary outcomes:
measure: Number of Subjects With Irritation Score of "0" at Baseline and One Week
timeFrame: Baseline and One Week
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Concentrics Research
state: Indiana
Study officials:
affiliation: Johnson & Johnson Consumer and Personal Products Worldwide
name: Sherryl Frisch
role: STUDY_DIRECTOR
affiliation: Johnson & Johnson Consumer and Personal Products Worldwide
name: Melissa Israel
role: STUDY_DIRECTOR
References:
Clinical trial NCT03982017: Heart Failure Self-care Mobile Application to Reduce Readmissions Trial
Official title: Heart Failure Self-care Mobile Application to Reduce Readmissions Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: readmission
quality of life
self-care
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2019-06-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a patient-centered comparative effectiveness feasibility pilot designed to examine an intervention to increase heart failure self-care and symptom recognition. The investigators will randomize 100 participants to receive either usual care at the time of discharge after heart failure admission or a smartphone application that enhances self-care.


Eligibility criteria: Inclusion Criteria:

* Inpatient admission for acute decompensated heart failure
* Left ventricular systolic or diastolic heart failure
* Owns a smartphone with a data plan

Exclusion Criteria:

* Hospice or life expectancy less than 6 months
* Palliative inotrope use
* Heart transplant listed, or status post transplant
* Ventricular assist devise present, or awaiting placement
* Not being discharged to home
* Unable to provide consent or comply with the intervention
* Current enrollment in a remote monitoring/ telehealth program

Primary outcomes:
measure: Percent of participants readmitted within 30 days
timeFrame: 30 days post index discharge
measure: Percent of participants readmitted within 90 days
timeFrame: 90 days post index discharge
measure: Time to readmission
timeFrame: from the date of enrollment until the date of first documented admission or date of death from any cause, whichever comes first, assessed up to 90 days
measure: Kansas City Cardiomyopathy Questionnaire at 30 days post enrollment
timeFrame: 30 days post index discharge
measure: Kansas City Cardiomyopathy Questionnaire at 90 days post enrollment
timeFrame: 90 days post index discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Amber E Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnson AE, Routh S, Taylor CN, Leopold M, Beatty K, McNamara DM, Davis EM. Developing and Implementing an mHealth Heart Failure Self-care Program to Reduce Readmissions: Randomized Controlled Trial. JMIR Cardio. 2022 Mar 21;6(1):e33286. doi: 10.2196/33286.
Clinical trial NCT05802017: Relation Between Adverse Reactions to Food, Physical Performance and Health in a Mediterranean Population
Official title: Relation Between Adverse Reactions to Food, Physical Performance and Health in a Mediterranean Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Food Allergy
Food Intolerance
Adverse Reaction to Food
Lead sponsor: Universidad Politecnica de Madrid
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Since the prevalence of adverse reactions to foodstuffs (ARFS) has been steadily increasing and has become an alarming health concern, the general objective of this study is to analyze the prevalence of ARFS in Spanish adults of different physical condition.

Detailed description: Individuals with associated diseases and symptomatology to ARFS will be selected and will be clinically and physically measured.

Eligibility criteria: Inclusion Criteria:

* Diseases and symptomatology associated to ARF.

Exclusion Criteria:

* Participation in other study.
* Pregnancy.
* Antibiotic treatment.
* Active Helicobacter pylori infection.
* Antidepressant, sleeping pill, or anxiolytic treatment.
* Job or lifestyle that potentially interferes with your regular sleep schedule.
* Active Cancer treatment.

Primary outcomes:
measure: Immunoglobulin G4 and E response in subjects with subjective symptoms of adverse reactions to food.
timeFrame: 4-month intervention
Secondary outcomes:
measure: Body composition in sedentary and physically active population.
timeFrame: 4-month intervention
measure: Physical condition in sedentary and physically active population.
timeFrame: 4-month intervention
measure: General health in subjects with subjective symptoms of adverse reactions to food.
timeFrame: 4-month intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Facultad de Ciencias de la Actividad Física y del Deporte
Study officials:
affiliation: Universidad Politecnica de Madrid
name: Lisset S Pantoja Arevalo, MSc
role: STUDY_CHAIR
affiliation: Universidad Politecnica de Madrid
name: Marcela Gonzalez Gross, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00108017: Comparison of the Effects of Two Glaucoma Drugs Over 24 Hours (0507A-137)(COMPLETED)
Official title: Randomized, Multicenter, Dbl-Masked, Parallel Study Evaluating the 24 Hr. Diurnal Ocular Hypotensive Effect of 2% Dorzolamide Hydrochloride/0.5% Timolol Maleate Combo. Ophthalmic Sol. in Patients w/ Open Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Ocular Hypertension
Keywords: Ocular hypertension (excessive pressure in the eye)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-04-13
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is comparing 2 medications for glaucoma and how effective they are at controlling glaucoma over the course of an entire day.


Eligibility criteria: Inclusion Criteria:

* Patients with glaucoma or ocular hypertension

Exclusion Criteria:

* Other eye conditions
* Poor vision
* Recent eye surgery
* Use of contact lenses
* Nursing or pregnant women
* Use of some other selected medications
* Drug or alcohol abuse
* Asthma
* Slow heart beat
* Allergy or previous reaction to study drugs

Primary outcomes:
measure: 24 hour diurnal IOP reduction after 8 weeks of treatment
timeFrame: After 8 weeks of treatment
Secondary outcomes:
measure: IOP reduction a) from baseline at 6 weeks; b) comparison with timolol; c) comparison day versus night
timeFrame: At 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Feldman RM, Stewart RH, Stewart WC, Jia G, Smugar SS, Galet VA. 24-hour control of intraocular pressure with 2% dorzolamide/0.5% timolol fixed-combination ophthalmic solution in open-angle glaucoma. Curr Med Res Opin. 2008 Aug;24(8):2403-12. doi: 10.1185/03007990802243366. Epub 2008 Jul 14.
citation: Olander KW, Galet VA, Jia G, Smugar SS, Stewart WC. Relationship between visual field severity and response to fixed combination dorzolamide/timolol or timolol alone. J Ocul Pharmacol Ther. 2009 Aug;25(4):357-64. doi: 10.1089/jop.2008.0104.
Clinical trial NCT01985217: Prevalence of Digestive Carriage of Integrons
Official title: Prevalence of Digestive Carriage of Integrons to Resistance in Two Populations in Limousin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Resistance to Antimicrobial
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2013-11-15
Enrollment: 492
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people working in the hospital kitchen

Brief summary: Bacterial resistance to antimicrobials is an increasing problem. Doctors occasionally face genuine therapeutic dead-ends, when attempting to cure nosocomial infections and, more and more frequently, community-acquired infections. Mastering antimicrobial resistance diffusion is nowadays a major Public Health issue.

Detailed description: Struggling against bacterial resistance to antimicrobials lays on three main measures:

* individual and collective hygiene.
* proper antibiotics practices, which could help reduce antibiotic selective pressure.
* better understanding of bacterial resistance mechanisms and resistance gene transfer between bacteria.

Integrons, gene capture and expression systems, are recognised as major players in resistance gene transfer, which accounts for the greater part of resistance emergence and dissemination. Integrons are typically described in Gram negative bacteria, isolated in man, environmental settings and animals. They encode resistances to nearly every class of antimicrobials. A strong link between integrons and resistance to multiple antibiotic compounds has been described and integron detection is a relevant indicator of resistance to multiple antibiotics.

The investigators project offers to study the impact of antibiotics on the frequency of integron intestinal carriage in the Limousin region and the genetic communities between the two groups.

This study will use an innovative real-time PCR technique to detect integrons directly in the sample without using traditional culture-based techniques. The investigators hope to detect new integron-carriers, notably patients for whom integrons are borne by non or poorly cultivable bacteria. Stool samples will be taken from two groups of subjects : 246 intensive-care unit patients under high antibiotic selective pressure, compared with 246 healthy individuals representative of the community, under a more usual selective pressure. In both groups, antibiotic consumption will be fully documented.

Eligibility criteria: Inclusion Criteria:

* adults \> 18 years
* patients Hospitalized in intensive care unit for at least 48 hours, including one antibiotic was found at least in the background (\<3 months).
* patients followed by the Department for Work and Health for bacteriological examination of stool
* possible information about antibiotic therapy provided

Primary outcomes:
measure: Positive PCR
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: Service de Virologie
Study officials:
References:
Clinical trial NCT01606917: Interventions for Lifestyle Changes to Promote Weight Reduction, a Randomized Controlled Trial in Primary Health Care
Official title: Interventions for Lifestyle Changes to Promote Weight Reduction, a Randomized Controlled Trial in Primary Health Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight/Obesity
Lead sponsor: Örebro County Council
Sponsor class: OTHER_GOV
First posted: 2012-05-28
Enrollment: 133
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: The purpose of this study is to examine the effects of a weight reduction program in adults, seen in a primary care setting, with overweight/obesity perceived as a health problem or with diseases related to overweight/obesity and ambitions to achieve weight reduction as part of treatment.

Detailed description: Patients seeking advice for overweight/obesity or illness related to overweight/obesity at eight primary health care centers in Sweden were randomized either to intervention or control care groups with both dietary advice and individualized advice on increased regular physical activity. Main outcome measures were reduction in body weight of 5 percent or more from study start.

Eligibility criteria: Inclusion Criteria:

* Adult patients between 18 and 70 years of age who consulted or were in care for overweight/obesity with or without type 2 diabetes
* Hypertension, CVD
* Coronary heart disease (CHD)
* Dyslipidemia
* Gallstone or musculoskeletal disorders

Exclusion Criteria:

* Patients were not eligible if they were already taking part in another weight control program
* Understood the Swedish language poorly
* Were mentally ill or had an alcohol or drug addiction.
* Nor were they eligible if they had a physical disability preventing intensified physical activity or were pregnant at study start.

Primary outcomes:
measure: Proportion of patients who achieved target weight at two years
timeFrame: 2 years
Secondary outcomes:
measure: Clinical or laboratory manifestations of their baseline illness (type 2 diabetes, hypertension, CHD, dyslipidemia) or death of any cause.
timeFrame: 5 years
Other outcomes:
Locations:
city: Orebro
country: Sweden
facility: Orebro County Council
Study officials:
affiliation: Family Medicine Research Centre, Örebro County Council, School of Health and Medical Sciences, Örebro University
name: Stefan P.O Jansson, MD PhD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jansson SP, Engfeldt P, Magnuson A, Pt GL, Liljegren G. Interventions for lifestyle changes to promote weight reduction, a randomized controlled trial in primary health care. BMC Res Notes. 2013 May 27;6:213. doi: 10.1186/1756-0500-6-213.
Clinical trial NCT05167617: Vitamin D Improves Clinical Manifestations in Asthmatic Children
Official title: Vitamin D Supplemental Therapy for Asthmatic Children May Improve Clinical Manifestations and Reduce IgE Serum Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma in Children
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 102
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objectives: Evaluation of the effect of vitamin D supplemental therapy (VDST) on clinical manifestation of bronchial asthma (BA) as judged by The International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire and estimated serum levels of immunoglobulin E (IgE).

Patients \& Methods: scores of ISAAC questionnaire and blood samples were obtained for estimation of serum IgE and 25-hydroxy VD (25-HVD) at booking time (T1) of 102 BA patients. VDST was provided as 2000 IU daily for 3 and 6 months for patients had moderate and mild HVD, respectively. At the end of 12-m after start of VDST (T2), ISAAC questionnaire and serum levels of 25-HVD and IgE were re-evaluated and the percentage of change was calculated.


Eligibility criteria: Inclusion Criteria:

* Patients in the age group of 6-14 years, free of exclusion criteria and complaining of chest wheezes were included in the study.

Exclusion Criteria:

* Presence of acute asthmatic attack, current or recurrent chest infection, allergic dermatological disorders, chronic rhino-sinusitis, deviated nasal septum, other nasal or palatal congenital anomalies, history of chronic exposure to allergens, or living in areas characterized by air pollution, being passive smokers since birth, presence of autoimmune disorders, serum 25-HVD \>50 nmol/L and presence of clinically evident HVD.

Primary outcomes:
measure: Clinical Improvement
timeFrame: 3 to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university
Study officials:
References:
Clinical trial NCT01639417: Pilot Functional Imaging Study to Evaluate Mechanisms Underlying Chronic Pain in Breast Cancer Patients
Official title: Pilot Functional Imaging Study to Evaluate Mechanisms Underlying Chronic Pain in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Breast Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2012-07-12
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Breast Cancer Survivors with and without Chronic Pain

Brief summary: The purpose of this study is to better understand why some women with breast cancer develop chronic pain.

Detailed description: Women with breast cancer who either have chronic pain or who do not have chronic pain will be asked to enroll. Those who participate will have pictures taken of their brain using MRI when they are lying still and also when pressure is being applied to their thumbnails. These pictures will be compared to patients without breast cancer who do not have pain and to those who have other types of pain, such as fibromyalgia. By taking and analyzing these pictures the investigators hope to understand more about why breast cancer survivors develop pain after their diagnosis and treatment. In the future the investigators hope to better treat the pain or possibly even prevent the pain from occurring in the first place.

Eligibility criteria: Inclusion Criteria:

* Breast Cancer Survivor with and without chronic pain
* Able to undergo MRI

Primary outcomes:
measure: Determination of differences in pain sensitivity and functional MRI in different groups of patients.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Lynn Henry, MD
role: PRINCIPAL_INVESTIGATOR
References: