louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05456763: Butyrate in Pediatric Inflammatory Bowel Disease
Official title: Sodium Butyrate Effectiveness in Children and Adolescents With Newly Diagnosed Inflammatory Bowel Diseases - Randomized Placebo-controlled Multicentre Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: Crohn's disease
ulcerative colitis
sodium butyrate
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The first prospective randomised placebo-controlled study in the IBD pediatric population was conducted to evaluate the effectiveness of oral sodium butyrate as add-on therapy in IBD.

Detailed description: Butyric acid's effectiveness has not yet been assessed in the pediatric inflammatory bowel disease (IBD) population. This study aimed to evaluate the effectiveness of oral sodium butyrate as an add-on to standard therapy in children and adolescents with newly diagnosed IBD.

This was a prospective, randomized, placebo-controlled multicentre study. Patients aged 6-18 years with colonic Crohn's disease or ulcerative colitis, who received standard therapy depending on the disease's severity, were randomized to receive 150 mg sodium butyrate twice a day (group A) or placebo (group B). The primary outcome was the difference in disease activity and fecal calprotectin concentration between the two study groups measured at 12 weeks of the study.

Eligibility criteria: Inclusion Criteria:

* 6 to 18 years of age;
* newly diagnosed, based on the modified Porto criteria, IBD with colon involvement;
* informed consent of the child's parents or guardians to participate in the study.

Exclusion Criteria:

* age \<6 years;
* taking probiotics or dietary supplements in the last 2 weeks prior to study enrollment;
* lack of consent of parents or guardians to participate in the study.

Primary outcomes:
measure: difference in remission rate (PCDAI for Crohn's disease)
timeFrame: 12 weeks
measure: difference in remission rate (PUCAI ulcerative colitis)
timeFrame: 12 weeks
Secondary outcomes:
measure: difference in disease activity for CD and UC patients
timeFrame: 12 weeks
measure: difference in calprotectin concentration
timeFrame: 12 weeks
measure: side effects
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00005563: Multicenter Asthma Research Collaboration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lung Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To study the epidemiology of emergency asthma by focusing on three Multicenter Asthma Research Collaboration (MARC) databases collected over a two-year period in adult and pediatric emergency departments.

Detailed description: BACKGROUND:

The Multicenter Airway Research Collaboration (MARC) was created by 12 emergency physicians in May 1996 to determine the best management of acute asthma in the emergency department. The principal investigator of MARC, Dr. Carlos Camargo, formed the MARC Steering Committee to help guide this collaboration. The MARC Coordinating Center is based at the Massachusetts General Hospital (Boston, MA). Financial support for MARC has come from a variety of sources, including government, foundations, and industry. The NHLBI study used MARC databases.

DESIGN NARRATIVE:

Five representative aims were to: 1) characterize acute asthma management in urban emergency departments (EDs) and then compare current practice with that recommended in the 1997 national guidelines; 2) examine gender differences in acute asthma; 3) identify reasons why minority patients with asthma go to (and possibly prefer) the ED for their asthma care; 4) characterize important clinical subgroups, such as acute asthma among pregnant women and patients with sudden-onset severe acute asthma; and 5) examine risk factors for asthma hospitalization and for relapse after ED discharge.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Emerman CL, Cydulka RK, Crain EF, Rowe BH, Radeos MS, Camargo CA Jr; MARC Investigators. Prospective multicenter study of relapse after treatment for acute asthma among children presenting to the emergency department. J Pediatr. 2001 Mar;138(3):318-24. doi: 10.1067/mpd.2001.111320.
citation: Emond SD, Reed CR, Graff LG IV, Clark S, Camargo CA Jr. Asthma education in the Emergency Department. On behalf of the MARC Investigators. Ann Emerg Med. 2000 Sep;36(3):204-11. doi: 10.1067/mem.2000.109168.
Clinical trial NCT04258735: Genetic Characteristics of Metastatic Breast Cancer Patients
Official title: Genetic Characteristics of Metastatic Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metastatic Breast Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Genomic analysis for metastatic breast cancer(MBC) patients

* Participant (Inclusion criteria)

  1. Patients who diagnosed metastatic/stage IV breast cancer
  2. Patients who were not received treatment for metastatic breast cancer on palliative setting
* Process

  (1) Tissue/ Blood sample
* At diagnosis, MBC tissue / blood sample (20cc) will be obtained.
* At disease progression after 1st line treatment for MBC, blood sample (20cc) will be obtained (tissue; optional)

  (2) WES, RNASeq, ctDNA, Exosome
* We will analyze genomic characteritics using WES, RNASeq, ctDNA, Exosome.


Eligibility criteria: Inclusion Criteria:

* Patients who diagnosed ad metastatic breast cancer
* Patients who were not received treatment on palliative setting

Exclusion Criteria:

* Patients who did not agree this study
* Patients who did not have any pathologic specimen at MBC diagnosis.

Primary outcomes:
measure: Genomic profiling of MBC patients
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan University School of Medicine
Study officials:
References:
Clinical trial NCT03282435: Treatment of Non-small Cell Lung Cancer With Cytokine-induced Killer (CIK) Cells Blocked by PD-1 Antibody
Official title: Treatment of Non-small Cell Lung Cancer With CIK Cells Blocked by PD-1 Antibody
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Dalian University
Sponsor class: OTHER
First posted: 2017-09-14
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: to evaluate the prognosis of non-small cell lung carcinoma patients under CIK cellular treatment with PD-1 blocking on top of the standard therapy


Eligibility criteria: Inclusion Criteria:

* non-small cell lung cancer;
* more than 50% tumor tissues positive with PD-L1;
* EGFR and ALK wild type
* no other tumors

Exclusion Criteria:

* with systematic diseases shortening survival

Primary outcomes:
measure: progression-free survival
timeFrame: 5 years
measure: metastasis-free survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Affiliated Zhongshan Hospital of Dalian University
name: xiaolin Yuan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03490435: Intestinal Parasites in Inhabitants of Kuyavian-Pomeranian Province in Poland
Official title: Diagnostics of Intestinal Parasitosis in Inhabitants of Kuyavian-Pomeranian Province in Poland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intestinal Disease, Parasitic
Chronic Disease
Keywords: Per os invasions
Giardiasis
Toxoplasmosis
Taeniasis
Cryptosporidiosis
Trichinosis
Ascariasis
Echinococcosis
Lead sponsor: Nicolaus Copernicus University
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 22
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy people and inviduals with undiagnosed diseases or/and chronic symptoms such as: hay fever, skin and food allergies or eg. chronic fatigue.

Brief summary: The goal of the proposed study is to assess the prevalence of intestinal parasitic diseases in adults and children. These invasions are included to "dirty hand diseases" (per os invasions), therefore it applies mainly preschool children.

Detailed description: It is estimated that 75% of the world's population is infected with parasites and although parasitic diseases are mostly observed in the poor tropical and subtropical countries, there are also many diseases caused by parasites in Poland. In Poland, particular attention is paid to the following parasitic diseases closely related to the digestive system: giardiasis, taeniasis (including cysticercosis), ascariasis, cryptosporidiosis, toxoplasmosis, trichinosis, echinococcosis.

Symptoms of such invasions may include: allergic rhinitis of unknown origin, chronic fatigue or food intolerance. Moreover, many of them are asymptotic, therefore the study group will consist of both healthy people and individuals with undiagnosed diseases or/and chronic symptoms.

Eligibility criteria: Inclusion Criteria:

* healthy and ailing individuals
* men and females
* adults and children

Exclusion Criteria:

* the participants were not be: incapacitated persons, soldiers, prisoners and persons dependent in any way from the investigators

Primary outcomes:
measure: Intestinal parasites
timeFrame: 1 day (single evaluation of current samples)
measure: Giardia antigen test
timeFrame: 1 day (single evalutaion of all samples through study completion)
Secondary outcomes:
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University
state: Kujawsko-Pomorskie
Study officials:
affiliation: Nicolaus Copernicus Univeristy
name: Paweł Sutkowy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01426035: Safety And Efficacy Study Of Topic Mucopolysaccharide Polysulfate Cream In The Superficial Varicose Veins Treatment
Official title: Phase III of Safety and Efficacy Study of Topic Mucopolysaccharide Polysulfate Cream 5mg/g in the Superficial Varicose Veins Treatment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: VARICOSE VEINS
Keywords: SUPERFICIAL VARICOSE VEINS
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2011-08-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the safety, tolerability and effectiveness of mucopolysaccharide polysulfate cream in the treatment of superficial varicose veins


Eligibility criteria: Inclusion Criteria:

* Patients must be able to understand the study procedures, agree to participate, and give written consent.
* Patients must be able to follow the study medication regimen.
* Patients with inflammatory process in superficial veins for more than 72 hours.
* Presence of symmetric lesions to compare one side to the other.

Exclusion Criteria:

* Pregnancy or risk of pregnancy.
* Lactation.
* Use of topical or systemic anti-inflammatory, antihistamine or immunosuppressive drugs within the last 48 hours prior to the study
* Any alteration at other deep veins.
* History of atopy or allergic diseases.
* History of allergy to any component of the formulations.
* Other conditions considered by the investigator as reasonable for non-eligibility

Primary outcomes:
measure: Efficacy - Symptoms reduction
timeFrame: Evaluation time: 15 days treatment
Secondary outcomes:
measure: Efficacy - patient evaluation
timeFrame: Evaluation time: 15 days treatment
Other outcomes:
Locations:
city: Osasco
country: Brazil
facility: Medcin Instituto Da Pele
state: São Paulo
Study officials:
affiliation: Medcin Instituto da Pele
name: FLAVIA ADDOR
role: PRINCIPAL_INVESTIGATOR
affiliation: EMS
name: Felipe Pinho, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00176735: Capecitabine and Radiation Therapy in Advanced Pancreatic Cancer
Official title: Pilot Trial of Capecitabine and Radiation Therapy With Pre and Post Combination Chemotherapy in Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2005-09-15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pancreatic cancer has traditionally been treated with chemotherapy and radiation therapy with limited results. Preliminary studies of parts of this program in patients with advanced pancreatic cancer have produced favorable results with acceptable side effects. We feel that this treatment sequence may help to slow and/or control the growth of pancreatic cancer.

This study will help doctors learn whether pancreatic cancer will respond to this treatment. This study will use the combination of two chemotherapy drugs, gemcitabine and cisplatin, before and after treatment with radiation therapy and an oral chemotherapy drug called capecitabine. This sequence of combination chemotherapy before and after radiation therapy, and radiation therapy with the drug capecitabine is what is under study. Parts of this sequence, for example, the combination of gemcitabine and cisplatin, have shown promising results in the treatment of pancreatic cancer. This research study is an attempt to combine these various parts.


Eligibility criteria: Eligibility Criteria

1. Patients must have cytologic or histologic confirmation of pancreatic carcinoma.
2. Patients must have unresectable disease with or without distant metastases. A status of unresectable will be based on review of helical CT scan and surgical consultation.
3. Patients with a history of previous abdominal irradiation or chemotherapy for pancreatic cancer are ineligible.
4. Patients must have an estimated life expectancy of at least 12 weeks and a Zubrod performance status of ≤ 2 (appendix I).
5. Patients must be 18 years of age or older. Patients with reproductive potential must agree to use an effective contraceptive method during treatment.
6. Patients must have adequate organ function defined as follows: bone marrow - granulocytes ≥ 1500/cmm, platelets \> 100,000/cmm, renal - serum Cre \< 1.5 mg/dl, hepatic - bilirubin \< 3 mg/dl.
7. Patients must be free of other active systemic malignancy or any other serious co-morbid medical or psychiatric condition that would interfere with safe delivery of protocol therapy.
8. Patients must be aware of the investigational nature of the therapy and provide written informed consent as per institutional guidelines prior to the initiation of treatment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Mark Zalupski, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03742635: Applying Prechtl's Assessment of General Movements for Preterm Infants Through Telemedicine
Official title: Feasibility and Reliability of Applying Prechtl's Assessment of General Movements for Preterm Infants Through Telemedicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Children's Miracle Network
First posted: 2018-11-15
Enrollment: 67
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Conduct General Movements Assessments (GMA) both in-person/via telemedicine ("real-time") and through recordings (standard of care).
Primary purpose: SCREENING

Brief summary: The investigators will implement a study to evaluate the hypothesis that applying General Movements Assessments (GMA) in a telemedicine setting with real-time scoring is feasible and comparable to scoring video recordings.

Detailed description: The investigators hypothesize that using telemedicine to conduct the GMA will improve early identification of risk for cerebral palsy and facilitate earlier referral and access to neurodevelopmental intervention. Preterm birth results from complex interactions of biological and socioeconomic risk factors, all of which continue to influence neurodevelopmental trajectories beyond the prenatal and neonatal period. Unfortunately many of the socioeconomic factors that contribute to increased risk of prematurity are also associated with decreased likelihood to attend appointments at high risk infant follow-up (HRIF) clinics. Early intervention has been shown to be most beneficial to infants with highest social risk. Additionally, mothers living in more rural communities tend to have higher social risk. They are often younger, more likely to be a single parent, and have lower income. Helping make follow-up more accessible and convenient for families through telemedicine and at an earlier age using the GMA has the potential to improve early identification, minimize loss to follow-up and ensure prompt referral to optimize outcomes for the most vulnerable babies in this already high-risk population.

Eligibility criteria: Inclusion Criteria:

* All preterm infants who meet the High-Risk Infant Follow Up (HRIF) Criteria (less than 32 weeks gestational age or birth weight less than 1500 grams) who are cared for at UC Davis Medical Center

Exclusion Criteria:

* Families who are non-English speakers requiring a translator
* Families who are unable to access data-capable wireless service to participate in telemedicine visits through Zoom.

Primary outcomes:
measure: Real-time versus video recording reliability
timeFrame: 9 months gestational age
Secondary outcomes:
measure: Video recording reliability
timeFrame: 9 months gestational age
measure: Early referral
timeFrame: 9 months gestational age
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California-Davis
state: California
Study officials:
References:
Clinical trial NCT06310135: Filtered Eyewear to Prevent Light-induced Melatonin Suppression - Aim 1
Official title: Filtered Eyewear to Prevent Light-induced Melatonin Suppression While Maintaining Visual Performance and Alertness in Night-shift Working Nurses - Aim 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Quality
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the relative effectiveness of monocular and binocular light exposures, with and without selective blue-blocking filtering, on nocturnal melatonin suppression, subjective sleepiness, and visual performance of night shift workers.

Detailed description: Over the course of six, 5-hour study nights, 30 participants will be randomized to 6 study conditions, 1) binocular dim-light control unfiltered, (2) monocular dim-light control (one eye occluded), (3) unfiltered binocular, (4) unfiltered monocular (non-dominant eye occluded), (5) filtered binocular (both eyes filtered), (6) filtered monocular (non-dominant eye filtered, the other non-filtered). Saliva samples will be collected every 30 minutes for melatonin levels. Participants will also be asked to provide subjective sleepiness and visual performance will be assessed. Study nights will be separated by one week and each participant will be randomized to one of the six study conditions each night. All participants will see all conditions.

Eligibility criteria: Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Bipolar disorder
* Seasonal depression
* Diabetes
* High blood pressure
* History of cancer
* Obstructing cataracts
* Macular degeneration
* Diabetic retinopathy
* Glaucoma
* Use of melatonin supplements
* Use of beta blockers
* Use of sleep medications
* Use of antidepressant medication

Primary outcomes:
measure: Melatonin Levels
timeFrame: Each night for 6 study nights
Secondary outcomes:
measure: Karolinska Sleepiness scale to measure Subjective Sleepiness
timeFrame: Each night for 6 study nights
measure: Numerical Verification Task (NVT)
timeFrame: Each night for 6 study nights
Other outcomes:
Locations:
city: Menands
country: United States
facility: Light and Health Research Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Mariana Figueiro
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00921635: A Study to Evaluate the Impact of Maintaining Hemoglobin Levels in Anemic Patients With Carcinoma of the Cervix
Official title: A Phase III Study to Evaluate the Impact of Maintaining Haemoglobin Levels Above 120g/L Verses Above 100g/L in Anaemic Patients With Carcinoma of the Cervix Receiving Concurrent Cisplatin and Radiation Therapy
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Cervical Cancer
Anemia
Keywords: Haemoglobin
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
First posted: 2009-06-16
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the feasibility, safety and short term effects on health related quality of life, of maintaining hemoglobin from 120 to 130 g/L versus from 100 to 110 g/L, with red cell concentrate (RCC) transfusion, in women having chemo-radiation for cancer of the cervix.


Eligibility criteria: Inclusion Criteria:

* Previously untreated cervix cancer
* FIGO stage IB2, II, IIIB, IVA
* Suitable for treatment with radical intent using concurrent cisplatin and pelvic radiation

Exclusion Criteria:

* Hemoglobin level above 125g/L
* Lower one-third vaginal involvement
* Para-aortic lymphadenopathy

Primary outcomes:
measure: The impact of maintaining hemoglobin levels above 120 g/L versus above 100 g/L
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Randiation Oncology
name: Yee-Min Jen
role: PRINCIPAL_INVESTIGATOR
References: