louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05673304: Preoperative Boost Associated With Neoadjuvant Chemotherapy in Luminal B Breast Cancer
Official title: Immune and Pathological Response in Breast Cancer After Preoperative Irradiation With Stereotactic Technique and Neoadjuvant ChemOtherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Radiotherapy
Keywords: Luminal B Breast Cancer
Neoadjuvant radiation therapy
Neoadjuvant chemotherapy
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: IBISCO TRIAL is a phase II trial aimed to demonstrate the improvement of pathological complete response (pCR) in Luminal B breast cancer (BC) patients treated with stereotactic radiation therapy (SBRT) as an anticipated boost associated with neoadjuvant chemotherapy (NAC).

As a secondary objective, histochemical and molecular analysis of the tumour and the inflammatory microenvironment will be performed.

Detailed description: IBISCO TRIAL is a phase II trial aimed to demonstrate the improvement of pCR in Luminal B breast cancer (BC) patients treated with stereotactic radiation therapy (SBRT) as an anticipated boost associated with neoadjuvant chemotherapy (NAC).

The primary endpoint will be evaluated on surgical specimen using the residual cancer burden (RCB) index.

Thirty patients with clinical stage T1-2 Luminal B BC, suitable for conservative surgery and with a clinical indication for NAC, will be enrolled in two years. An observation cohort will also be created with patients fulfilling inclusion criteria who refuse enrollment in the interventional cohort and for patients where SBRT boost appears not feasible after enrollment for technical issues.

As a secondary objective, histochemical and molecular analysis of the tumour and the inflammatory microenvironment will be performed.

After the completion of neoadjuvant treatments, surgery and adjuvant therapies (endocrine therapy and whole breast irradiation) will be performed as for clinical practice

Eligibility criteria: Inclusion Criteria:

* Luminal B-like BC, cT1-2
* Indication for neoadjuvant chemotherapy

Exclusion Criteria:

* Pregnancy
* Breast feeding
* Patient not available for follow up

Primary outcomes:
measure: pCR
timeFrame: 6 month after SBRT (at surgery)
Secondary outcomes:
measure: acute toxicity
timeFrame: immediate to 6 months after SBRT
measure: late toxicity
timeFrame: from 6 months after SBRT
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Alessio G Morganti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02052804: Understanding and Treating Heart Failure With Preserved Ejection Fraction: Novel Mechanisms, Diagnostics and Potential Therapeutics
Official title: Understanding and Treating Heart Failure With Preserved Ejection Fraction: Novel Mechanisms, Diagnostics and Potential Therapeutics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2014-02-03
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of Alberta, Canada with heart failure or at risk for developing heart failure

Brief summary: The objectives of this study are: 1) to design new diagnostic criteria used to accurately define heart failure with preserved ejection fraction (HFpEF); 2) to better define the risk factors associated with HFpEF; 3) to elucidate the clinical, cellular and molecular mechanisms involved with the development and progression of HFpEF; 4) to design and test new therapeutic strategies for patients with HFpEF.


Eligibility criteria: Inclusion Criteria:

* Group 1 No clinically overt heart failure
* Group 2 Known coronary artery disease
* Group 3 Known heart failure with preserved ejection fraction
* Group 4 Known heart failure with reduced ejection fraction
* Group 5 Healthy age-matched controls

Exclusion Criteria:

* Age \<18 years
* Known malignancy with expected survival \<1 year
* Pregnant or recent pregnancy \<6 months
* Recent event (\<2 weeks since Acute Coronary Syndrome, Heart failure or other admission
* Severe mitral or aortic stenosis

Primary outcomes:
measure: Percent of patients meeting new diagnostic criteria for HFpEF
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Jason Dyck, PhD
role: STUDY_DIRECTOR
References:
citation: Zordoky BN, Sung MM, Ezekowitz J, Mandal R, Han B, Bjorndahl TC, Bouatra S, Anderson T, Oudit GY, Wishart DS, Dyck JR; Alberta HEART. Metabolomic fingerprint of heart failure with preserved ejection fraction. PLoS One. 2015 May 26;10(5):e0124844. doi: 10.1371/journal.pone.0124844. eCollection 2015.
citation: Ezekowitz JA, Becher H, Belenkie I, Clark AM, Duff HJ, Friedrich MG, Haykowsky MJ, Howlett JG, Kassiri Z, Kaul P, Kim DH, Knudtson ML, Light PE, Lopaschuk GD, McAlister FA, Noga ML, Oudit GY, Paterson DI, Quan H, Schulz R, Thompson RB, Weeks SG, Anderson TJ, Dyck JR. The Alberta Heart Failure Etiology and Analysis Research Team (HEART) study. BMC Cardiovasc Disord. 2014 Jul 25;14:91. doi: 10.1186/1471-2261-14-91.
Clinical trial NCT01141504: Effect of Oral Adenosine-triphosphate (ATP) on Human Muscle Performance
Official title: Effect of Oral ATP on Human Muscle Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Supplemental ATP
Muscle Work Performed
Muscle Fatigue
Lead sponsor: Metabolic Technologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Iowa State University
First posted: 2010-06-10
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Adenosine-triphosphate (ATP) serves as the sole energy source for muscle contraction. Therefore human performance of brief maximal exercise is limited, in part, by the availability of ATP to the contracting muscle. Because muscle ATP storage is small (enough to sustain maximal exercise for less than 1 second), factors that enhance either storage or resynthesis of ATP may have a positive impact on repeated muscle contractions. The current study will test the hypothesis that increasing ATP availability to muscle via oral supplementation will improve performance of repeated high intensity exercise as measured by a) work performed in each of the three 50 contraction fatigue tests, b) sum of total work performed, and c) percentage decrement in total work from the first to third third 50 contraction test.

Detailed description: To date we have studied 10 subjects who have followed through with all 3 of the original interventions (Placebo, 250 mg PeakATP/d and 400 mg PeakATP/d). Currently we have received approval and are expanding the study with 5 additional subjects who will receive the Placebo, 400 mg PeakATP/d and the 400 mg PealATP/d plus proprietary blend interventions.

Eligibility criteria: Inclusion Criteria:

* No major medical conditions;
* Able to perform fatigue testing procedures;
* Not currently taking prescription medications;
* Not currently taking dietary supplements (a daily multi-vitamin not exceeding RDA is permitted)

Exclusion Criteria:

* Major medical condition affecting metabolism or general function;
* Not able to perform fatigue testing;
* Taking prescription medications;
* Taking a dietary supplement other than a multi-vitamin not exceeding RDA

Primary outcomes:
measure: Work Performed
timeFrame: Measured after 15 days of intervention
Secondary outcomes:
measure: Decrease in work performed in each successive test
timeFrame: Measured after 15 days of intervention
Other outcomes:
Locations:
city: Ames
country: United States
facility: Iowa State University
state: Iowa
Study officials:
affiliation: Metabolic Technologies Inc.
name: John A Rathmacher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00724204: Safety Assessment of Lactobacillus Salivarius CECT5713 in 6 Months Old Children
Official title: Functional Evaluation of a Follow on Formula Supplemented With Lactobacillus Salivarius CECT5713
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infection
Keywords: probiotics
safety
fecal microbiota
infections
Lead sponsor: Puleva Biotech
Sponsor class: INDUSTRY
Collaborators: name: Hospital Clinico Universitario San Cecilio
First posted: 2008-07-29
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of the trial is to evaluate safety of a follow on formula supplemented with Lactobacillus salivarius CECT5713. A randomized double blind placebo controlled trial was carried out. Eighty six months old children were recruited by the department of pediatrics of Hospital Univeristario San Cecilio. Children were divided in two groups that consumed a follow on formula supplemented or not with the probiotic strain during 6 months. Fecal samples were obtained at the recruitment, at 3 months and at the end of the trial. In addition revision by the pediatrician was performed once a month and possible adverse effects were recorded both by the pediatrician and by parents.


Eligibility criteria: Inclusion Criteria:

* Healthy six months old children

Exclusion Criteria:

* Lactose intolerance
* Cow's milk protein allergy
* Serious metabolic diseases
* Antibiotic treatment
* Serious gastrointestinal diseases

Primary outcomes:
measure: Adverse reactions
timeFrame: 3 months and 6 months
Secondary outcomes:
measure: growth parameters (height, length, head circumference)
timeFrame: 3 months and 6 months
measure: Fecal microbiota
timeFrame: 3 months and 6 months
measure: Fecal short chain fatty acids
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
Study officials:
affiliation: Department of Pediatrics. Hospital Universitario San Cecilio
name: José A Maldonado, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nutrition and Health. Puleva Biotech. Granada
name: Mónica Olivares, PhD
role: STUDY_CHAIR
affiliation: Department of Nutrition and Helath. Puleva Biotech. Granada
name: Federico Lara-Villoslada, PhD
role: STUDY_DIRECTOR
References:
citation: Maldonado J, Lara-Villoslada F, Sierra S, Sempere L, Gomez M, Rodriguez JM, Boza J, Xaus J, Olivares M. Safety and tolerance of the human milk probiotic strain Lactobacillus salivarius CECT5713 in 6-month-old children. Nutrition. 2010 Nov-Dec;26(11-12):1082-7. doi: 10.1016/j.nut.2009.08.023. Epub 2009 Dec 16.
Clinical trial NCT01177904: Early Progesterone Cessation After in Vitro Fertilization
Official title: Early Progesterone Cessation After in Vitro Fertilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnant Women
Lead sponsor: IVI Madrid
Sponsor class: OTHER
First posted: 2010-08-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There seems to be a general consensus on the supplementation of progesterone (P4) for luteal phase support (LPS) to all women after in vitro fertilization (IVF) treatment. However, there is no agreement about the precise duration of LPS.

Detailed description: The objective of the study is to investigate the effect of early cessation of progesterone for LPS after IVF treatment on the pregnancy outcome, with special interest in determining the miscarriage rate and episodes of bleeding between the date of the first ultrasound (US) and up to 12 weeks of gestation.

Patients start to receive 200 mg twice a day of P4 on the day after oocyte retrieval.

All patients which show a gestational sac in their uterus in the first US are included in this study and randomized.

Inclusion criteria:

1. Patients who underwent ovarian stimulation using GnRH analogues,
2. Fresh embryo transfer,
3. LPS by vaginal micronized P4,
4. Clinical pregnancy demonstrated by US and
5. Informed consent signed.

Exclusion criteria:

Patients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.

Eligibility criteria: Inclusion Criteria:

1. Patients who underwent ovarian stimulation using GnRH analogues,
2. Fresh embryo transfer,
3. LPS by vaginal micronized P4,
4. Clinical pregnancy demonstrated by US and
5. Informed consent signed.

Exclusion Criteria:

Patients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.

Primary outcomes:
measure: Number of Bleeding Episodes
timeFrame: Up to year
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: IVI-Madrid
Study officials:
affiliation: IVI Madrid
name: Juan A Garcia-Velasco, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Kohls G, Ruiz F, Martinez M, Hauzman E, de la Fuente G, Pellicer A, Garcia-Velasco JA. Early progesterone cessation after in vitro fertilization/intracytoplasmic sperm injection: a randomized, controlled trial. Fertil Steril. 2012 Oct;98(4):858-62. doi: 10.1016/j.fertnstert.2012.05.046. Epub 2012 Jun 29.
Clinical trial NCT03035604: Comprehensive Nutritional Geriatric Assessments in Identifying Malnutrition in Older Cancer Participants
Official title: Malnutrition in Older Cancer Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 180
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with hematologic and solid tumor cancers, undergo a comprehensive geriatric assessment by a geriatrician

Brief summary: This trial studies how well comprehensive nutritional geriatric assessments work in identifying malnutrition in older cancer participants. Comprehensive nutritional geriatric assessments may help doctors learn about ways to check for malnutrition (loss of weight/appetite that may result in health problems) that is due to cancer or cancer treatment.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate whether nutritional status, as determined by each of 4 screening tools (Mini Nutritional Assessment \[MNA\], weight loss, body mass index \[BMI\], and lean muscle mass), correlates with 6-month and 12-month mortality in older cancer patients after geriatric assessment, after adjusting for covariates.

II. To evaluate whether nutritional status, as determined by each of by 4 screening tools (MNA, weight loss, BMI, and lean muscle mass) correlates with 6-month and 12-month unplanned hospitalization in older cancer patients who undergo geriatric assessment, after adjusting for covariates.

III. To evaluate whether nutritional status, as determined by each of 4 screening tools (MNA, weight loss, BMI, and lean muscle mass) correlates with 6-month and 12-month hospital readmissions in older cancer patients who undergo geriatric assessment, after adjusting for covariates.

OUTLINE:

Participants undergo nutritional geriatric assessment over 15 minutes in person or on the phone every 3 months for 12 months.

Eligibility criteria: Inclusion Criteria:

* With hematologic and solid tumor cancers.
* Undergo a comprehensive geriatric assessment by a geriatrician.

Exclusion Criteria:

* Unable or unwilling to sign consent form.
* Life expectancy under 6 months.

Primary outcomes:
measure: Mortality
timeFrame: At 6 months
Secondary outcomes:
measure: Mortality
timeFrame: At 1 year
measure: Unplanned hospitalization rate
timeFrame: At 6 months and 1 year
measure: Hospital readmission rate
timeFrame: At 6 months
measure: Re-hospitalization rate
timeFrame: At 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Mehnaz Shafi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00569504: Prevalence of the Metabolic Syndrome in SPR Taking Antipsychotics
Official title: Prevalence of the Metabolic Syndrome in Patients With Schizophrenia Taking Antipsychotics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metabolic Syndrome
Schizophrenia
Keywords: schizophrenia
antipsychotics
metabolic syndrome
prevalence
Lead sponsor: Seoul National Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Korea Otsuka Pharmaceutical Co., Ltd.
First posted: 2007-12-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: DSM-IV diagnosis of schizophrenia

Brief summary: The purpose of this study is to assess the cross-sectional prevalence of the metabolic syndrome in patients with schizophrenia taking antipsychotics.

Detailed description: Schizophrenic patients taking any kind of antipsychotics for at least 1 year at the Seoul National Hospital will be participated in this study.

we are planning to enroll approximately 1000 patients with schizophrenia.

For each subject

* abdominal circumference
* body mass index
* lipid profile : TG, HDL-chlo, total chol
* systolic/diastolic blood pressure
* fasting blood glucose will be measured.

we will calculate the rates of patients who meet the criteria for the Metabolic syndrome.

1. Abdominal obesity : absolute criteria
2. 2 or more of followings

   1. Triglyceride ≥ 150mg/dL or ongoing treatment
   2. HDL-cholesterol \< 40mg/dL (men) HDL-cholesterol \< 50mg/dL (female) or ongoing treatment
   3. Hypertension 130mmHg ≥ systolic 85mmHg ≥ diastolic or ongoing treatment
   4. FBS ≥ 100mg/dL or previous diagnosis of type II DM

Eligibility criteria: Inclusion Criteria:

* Patients taking a same antipsychotics at least more than one year
* schizophrenia or schizoaffective disorder

Exclusion Criteria:

* none

Primary outcomes:
measure: metabolic syndrome
timeFrame: cross-sectional
Secondary outcomes:
measure: each factor of metabolic syndrome
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National Hospital
Study officials:
affiliation: Seoul National Hospital
name: Jong-il Lee, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06446804: Follow-up of Migraine Patients on Eptinezumab
Official title: Feedback on the Use of Eptinezumab: Efficacy at 6 Months in Severe Migraine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients with severe migraine with at least 8 migraine days per month and failure of at least 2 disease-modifying therapies, treated with quarterly infusions of eptinezumab since March 2023 in a day hospital at the Saint-Denis hospital and the Nîmes university hospital.

Brief summary: The October 2022 Transparency Commission considers that VYEPTI (eptinezumab) is a treatment option for patients suffering from severe migraine with at least 8 migraine days per month, who have failed at least two prophylactic treatments and have no cardiovascular impairment.

Since the beginning of 2023, eptinezumab has been available in France as an inpatient treatment prescribed by a migraine neurologist in a growing number of centres. The Saint-Denis Hospital and the Nîmes University Hospital are among the first centres to have started. The investigators from these 2 centres have therefore decided to pool their data to provide the first French feedback on its effectiveness.


Eligibility criteria: Inclusion Criteria:

* Adult patients suffering from severe migraine with at least 8 migraine days per month

  * Patients who have failed at least 2 disease-modifying treatments,
  * Patients treated with quarterly infusions of eptinezumab since March 2023 in a day hospital at Saint-Denis Hospital and Nîmes University Hospital.

Exclusion Criteria:

* Patient refusing to participate

Primary outcomes:
measure: Headaches and migraines per month
timeFrame: 6 months
measure: Responders
timeFrame: 6 months
measure: Duration
timeFrame: 6 months
measure: HIT6 scores (disability score)
timeFrame: 6 months
measure: HAD (anxiety/depression score)
timeFrame: 6 months
measure: Concomitant treatments
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
city: Saint-Denis
country: France
facility: CH de Saint Denis
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Anissa MEGZARI
role: STUDY_DIRECTOR
References: