louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05785078: Evaluation of a Flu Vaccination Program Directed at Pregnant Women Assisted at a Research Hospital in Italy.
Official title: Evaluation of the Impact of a Program to Raise Awareness About Flu Vaccination and a Vaccination Campaign Aimed at Women Participating in the Childbirth Preparation Course Held at Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza Vaccination
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 119
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women and their partners attending the childbirth preparatory course held at Fondazione Policlinico Universitario "A. Gemelli" IRRCS

Brief summary: Influenza is a serious Public Health problem, which causes a high number of cases and deaths worldwide each year. In Italy, about 8 million cases were reported in the 2018/2019 flu season, 809 of which were severe, with 198 deaths. Pregnant women are considered one of the most at-risk groups, as infection can lead to serious complications for the mother and fetus. The Italian Ministry of Health recommends free flu vaccination for pregnant women in the second or third trimester, as the vaccine is safe and effective in protecting the mother, fetus and newborn.

During the 2018-2019 flu season, the Fondazione Policlinico Universitario A. Gemelli IRCCS (FPG) held an educational session on maternal and childhood vaccinations in the context of the Childbirth Preparation Course held monthly at the FPG, offering the on-site flu vaccination to participants and their partners, if present.

The objectives of this study are: to improve knowledge and attitudes regarding vaccination in the course participants, assessing their changes through a pre-post anonymous questionnaire; to evaluate the impact of the flu vaccination strategy implemented, through the analysis of vaccination coverage.


Eligibility criteria: Inclusion Criteria:

* Attendance to the educational session about vaccination in the context of the childbirth preparatory course held at Fondazione Policlinico Universitario "A. Gemelli" IRRCS

Exclusion Criteria:

* None

Primary outcomes:
measure: Differences in knowledge and attitudes regarding vaccination
timeFrame: 4 months
Secondary outcomes:
measure: Vaccination compliance
timeFrame: 4 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario "A. Gemelli" IRCCS
state: RM
Study officials:
References:
Clinical trial NCT05961878: Diet in Elderly With Type 2 Diabetes
Official title: Efficacy of Diet in Elderly With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sarcopenia
Sarcopenic Obesity
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Complications
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sarcopenia is characterized by progressive and generalized loss of skeletal muscle mass which may affect performance. Diabetes can affect muscle cell function, making sarcopenia worse.

This is a prospective and interventional study on a elderly population affected by type 2 diabetes mellitus. All subjects, recruited will undergo tests for the diagnosis of sarcopenia according to the EWGSOP2 criteria. All subjects, both sarcopenic and non-sarcopenic, will be introduced to a targeted nutritional program aimed at improving the composition of the diet, in terms of both micro- and macro-nutrients.

Detailed description: The sample will consist of about 100 subjects (50 sarcopenic and 50 non-sarcopenic) who receive the nutritional program. Particular attention will be paid to the intake of an adequate protein intake for the elderly subject (1.1 g/kg/day). A food diary will be required to assess daily protein-calorie intake and questionnaires to assess daily physical activity and quality of life.

The primary objective is to assess the efficacy of nutritional intervention in elderly affected by type 2 diabetes mellitus and sarcopenia. The secondary objective is to identify the prevalence of sarcopenia in patients with type 2 diabetes mellitus compared to non-diabetic subjects and to verify the relationship between pharmacological therapy and the presence of sarcopenia as well as evaluate any changes in style and quality of life and of glycometabolic compensation.

Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes
* BMI \>20 kg/m2
* HbA1c ≥6.5% (48 mmol/mol) e ≤10% (86 mmol/mol)

Exclusion Criteria:

* T1DM or LADA
* Patients with serious primary diseases of heart, brain, liver, kidney and hematopoietic system

Primary outcomes:
measure: Handgrip test
timeFrame: 1 years
Secondary outcomes:
measure: Glycemic control
timeFrame: 1 year
measure: Anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS
timeFrame: 1 year
measure: Dietary lifestyle
timeFrame: 1 year
Other outcomes:
measure: health-related quality of life
timeFrame: 1 year
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Study officials:
References:
Clinical trial NCT03855878: Observation of the Incidence and Natural History of MGUS in Patients Undergoing Weight Reduction Surgery
Official title: Prospective Observation of the Incidence and Natural History of Monoclonal Gammopathy in Patients Undergoing Weight Reduction Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Monoclonal Gammopathy of Undetermined Significance
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 209
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To evaluate the incidence of MGUS in obese subjects 30 years and older planning to undergo weight reduction surgery or who have agreed to enter into a physician monitored weight loss program.

Brief summary: Screening study to determine incidence of MGUS in this patient population

Detailed description: This study is designed to observe the incidence of monoclonal gammopathy of undetermined significance (MGUS) among obese patients planning to have weight reduction surgery or planning to enter into a physician monitored weight loss program and to follow the regression or progression of MGUS following surgery or the initiation of the weight loss program.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients 30 years or older planning to undergo weight reduction surgery or planning to enter into a physician monitored weight loss program
2. Patients must be obese, defined as a BMI ≥ 30 as calculated by the formula:

   weight in pounds / height squared x 703 = BMI
3. Subject consent and authorization for the release of health information must be obtained according to local institutional guidelines.
4. To remain in the study for the follow-up phase, the baseline screening test must indicate that a patient has MGUS.

Exclusion Criteria:

1. No history of any malignancy except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years.
2. No concurrent or planned participation in randomized trials of weight loss.
3. A patient will be excluded from the follow-up phase if the baseline screening test indicates they do not have MGUS

Primary outcomes:
measure: Rate of MGUS
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Rafat Abonour, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02593578: Clinical Sequencing Project for Metastatic Cancer Patients for Personalized Cancer Clinic.
Official title: Clinical Sequencing Project for Metastatic Cancer Patients for Personalized Cancer Clinic.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-11-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with treatment-refractory malignancy

Brief summary: The next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly. The genome analysis needs systematic infra and database based on personal genetic information. Therefore, a big data of genome-clinical information is important.

To determine the feasibility of the use of tumor's molecular profiling and targeted therapies in the treatment of advanced cancer and to determine the clinical outcome(Response rate,PFS, duration of response and overall survival )of patients with advanced cancer, the investigators are going to take a tumor tissue of patients and process molecular profiling and receive molecular profile directed treatments.


Eligibility criteria: Inclusion Criteria:

1. Subject is at least 19 years of age.
2. Subject has a histologically or cytologically confirmed diagnosis of hepatocellular carcinoma/rare cancer, melanoma, neuroendocrine tumor, sarcoma etc.
3. Prior treatment with anti-PDL1 antibody or immune check point inhibitor or ramucirumab therapy in the First-line or maintenance setting is allowed
4. They must have refractory or progressive disease for which there is no further curative therapy available.
5. Be willing to provide fresh tissue for biomarker analysis, and, based on the adequacy of the tissue sample quality for assessment of biomarker status.
6. Must have a life expectancy of 3 months or more
7. Written and voluntary informed consent understood, signed and dated.

Exclusion Criteria:

1. Patients who do not have enough tissue for acquisition

Primary outcomes:
measure: Response rate
timeFrame: 1 year
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 1 year
measure: Duration of response
timeFrame: 1 year
measure: Overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT03337178: Fitbit Pilot Study in Post-operative Lumbar Degenerative Spinal Stenosis Patients
Official title: Fitbit Pilot Study to Increase Physical Activity and Overall Health in Post-operative Lumbar Degenerative Spinal Stenosis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Degenerative Spinal Stenosis
Lead sponsor: The London Spine Centre
Sponsor class: OTHER
First posted: 2017-11-08
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Spinal stenosis is a common orthopedic spine condition that limits individuals ability to walk and stand because of nerve compression. Surgical treatment can alleviate leg pain and improve function such as increasing physical activity. This study will use Fitbit technology to monitor patient's post-operative physical activity. It will evaluate the efficacy of a Fitbit incentive based walking program on improving post-operative physical activity and rehabilitation.


Eligibility criteria: Inclusion Criteria:

* 60 years of age and older
* diagnosed with neurogenic claudication or radiculopathy secondary to central or lateral recess stenosis between L3-L5 confirmed by CT or MRI
* consent for surgical treatment

Exclusion Criteria:

* traumatic stenosis from a pathologic fracture
* inflammatory spine disease
* peripheral arterial disease
* hip or knee arthritis or pulmonary or circulatory diseases for which exercise is contraindicated
* severe or progressive neurologic deficit effecting ambulatory ability
* cancer
* no access to a computer or mobile device
* inability to complete the questionnaires or provide follow-up (i.e. lack of permanent address, substance abuse, interfering psychiatric illness).

Primary outcomes:
measure: Self-Paced Walking Test
timeFrame: Change in 3 months post-op from baseline
Secondary outcomes:
measure: Patient Recruitment
timeFrame: Number consented by 17 months
measure: Self-paced walking test
timeFrame: Change in 3 months post-op from baseline
measure: Steps walked/day
timeFrame: Change in 3 months post-op from baseline
measure: Leg Pain
timeFrame: Change in 3 months post-op from baseline
measure: Back Pain
timeFrame: Change in 3 months post-op from baseline
measure: General Health
timeFrame: Change in 3 months post-op from baseline
measure: Functional Ability
timeFrame: Change in 3 months post-op from baseline
measure: Functional Ability
timeFrame: Change in 3 months post-op from baseline
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
References:
Clinical trial NCT05640778: Neoadjuvant Dalpiciclib Plus Aromatase Inhibitors in Luminal B/HER2-negative Breast Cancer (DANCER)
Official title: Efficacy and Safety of Neoadjuvant Dalpiciclib Combined With Endocrine Therapy in Luminal B/HER2-negative Breast Cancer and Biomarker Analysis: a Single-arm, Open-label Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Luminal B/HER2-negative Breast Cancer
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: GeneCast Biotechnology Co., Ltd.
First posted: 2022-12-07
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the efficacy and safety of Dalpiciclib combined with aromatase inhibitors as a neoadjuvant therapy in Luminal B/HER2-negative breast cancer.


Eligibility criteria: Inclusion Criteria:

* Patient is ≥ 18 years-old at the time of consent to participate this trial
* Famale stage I-III breast cancer patients
* HR-positive（ER≥10%）, HER2-negtive invasive breast cancer, either Ki67≥20% and/or PgR\<20%
* No prior anti-cancer treatment
* ECOG 0-1

Exclusion Criteria:

* Known to have other aggressive malignant tumor in the past 5 years.
* Bilateral breast cancer; Inflammatory breast cancer; Occult breast cancer; Distant metastasis confirmed by pathology.
* There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia.
* Female patients during pregnancy or lactation.
* The investigator determines that subjects are not appropriate to participate in the study due to other factors.

Primary outcomes:
measure: Complete cell cycle arrest（CCCA, defined as ki67≤2.7%）rate at 2 weeks of treatment
timeFrame: 3 years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: 3 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
Study officials:
References:
Clinical trial NCT06982378: GLP-1 RA on Liver OMICS in MASLD
Official title: Effect of Glucagon-like Peptide -1 Receptor Agonist on Liver Tissue and Plasma Lipids in MASLD
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: NAFLD
Diabetes
Obesity
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: known diagnosis of MASLD by histology, also have diabetes/ obesity

Brief summary: In patients with type II diabetes mellitus (T2DM) and obesity, an excess plasma-free fatty acid is found with an associated increased lipid accumulation in adipocytes and liver tissue. Lipid droplet accumulation in the hepatocytes is an initial step in the development of metabolic dysfunction associated steatotic liver disease (MASLD. Insulin resistance, which is associated with T2DM, mediates the inflammation of these lipids, resulting in the progression of MASLD to metabolic dysfunction associated steatotic hepatitis (MASH). Hence, in T2DM, obesity, and MASLD, changes in the lipid profile occur, and they are interrelated.

In this study, we aim to assess improvement in the lipidomic, its associated metabolic changes and evaluate the co-regulated genes in the liver tissue among patients with MASLD with intervention with GLP-1 RA, which has shown to benefit T2DM and obesity.

Detailed description: The study involves patients with a diagnosis of MASLD by histology and have diabetes/obesity. The 'omics' ( lipidomics, proteomics, metabolites, and inflammatory profiles and transcriptomics) data of liver tissue and plasma of patients will be compared between patients who have received 1 year of GLP-1 treatment with those who did not have GLP-1 agents.

The study will evaluate the changes in different 'omics' and metabolites in the liver tissue following the use of GLP-1 agents in these patients

Eligibility criteria: Inclusion Criteria:

* known diagnosis of MASLD by histology, also have diabetes/ obesity
* on treatment with GLP-1 RA at stable dose

Exclusion Criteria:

* unable to have a liver biopsy, recent change in medication for diabetes or hyperlipidemia
* on immunosuppression, liver or kidney transplant
* pregnancy

Primary outcomes:
measure: Changes in lipidomics profile on use of GLP-1 RA
timeFrame: 1 year
Secondary outcomes:
measure: Changes in associated proteomics and transcriptomics with the use of GLP-1 RA
timeFrame: 1 year
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
Study officials:
References:
Clinical trial NCT01108978: Evaluating the Efficacy and Safety of Dehypotin® in the Patients With Type 2 Diabetes Mellitus or Cardiovascular Disease
Official title: Phase IV Study for Evaluating the Efficacy and Safety of Dehypotin® in the Patients With Type 2 Diabetes Mellitus or Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Cardiovascular Disease
Hypercholesterolemia
Keywords: Type 2 Diabetes Mellitus
Cardiovascular Disease
hypercholesterolemia
Lead sponsor: Nang Kuang Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: National Taiwan University Hospital
First posted: 2010-04-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
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 evaluate the Efficacy and Safety of Dehypotin® in the Patients with Type 2 Diabetes Mellitus or Cardiovascular Disease. Eligible patients will be randomly assigned to 1 of 2 arms, either Dehypotin® or placebo, and will receive the diet advisement throughout the study.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age 20-75 years
* Diagnosis of type II Diabetes Mellitus for at least 3 months and/or clinical evident cardiovascular disease (CVD)
* A hemoglobin A1c concentration has to be \< 8% before screening

Exclusion Criteria:

* Women of child bearing potential who are pregnant, breastfeeding or not using effective contraceptives
* Known hypersensitivity to Pravastatin or any of its components
* Have a history of homozygous familial hypercholesterolemia or known type III hyperlipoproteinemia
* Significant medical illness
* Known serious conditions, e.g. serum creatine kinase(CK)levels 2.5 times upper limit of normal
* Subjects being treated with drugs influence serum lipid concentrations
* Subjects who have cancer or been receiving the cancer chemotherapy

Primary outcomes:
measure: Evaluation absolute and percentage reductions in low-density lipoprotein cholesterol (LDL-C) by fasting biochemistry examination
timeFrame: 12-week treatment
Secondary outcomes:
measure: Evaluation of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides by fasting biochemistry examination
timeFrame: 12-week treatment
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Nang Kuang Pharmaceutical Co., LTD
state: Xinhua Township
Study officials:
affiliation: National Taiwan University Hospital
name: Yang Wei Shiung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00309478: Randomized Study Comparing CMF and Goserelin + Tamoxifen in Premenopausal Receptor-positive Patients
Official title: A Randomized Phase III Study Comparing Cyclophosphamide + Methotrexate + Fluorouracil vs. Goserelin + Tamoxifen in Premenopausal, Hormone Receptor-positive, Lymph Node-positive or -Negative Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Early-stage Breast Cancer
Keywords: Cyclophosphamide
Methotrexate
Fluorouracil
Goserelin
Tamoxifen
Breast cancer
Lead sponsor: Austrian Breast & Colorectal Cancer Study Group
Sponsor class: NETWORK
Collaborators: name: AstraZeneca
First posted: 2006-04-03
Enrollment: 1099
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primarily, this clinical investigation compared the efficacy of cyclophosphamide + methotrexate + fluorouracil chemotherapy vs. goserelin + tamoxifen treatment in terms of prognosis (disease-free survival, overall survival) in premenopausal patients with potentially curative, operated hormone receptor-positive breast cancer.


Eligibility criteria: Inclusion Criteria:

* Premenopausal patients with histologically verified, lymph node-negative (pT1c-pT3) or lymph node-positive (pT1a-pT3) breast cancer
* Hormone receptor-positive status
* More than 6 histologically examined lymph nodes
* Laboratory parameters

  1. hematopoiesis: \> 3500/µl leukocytes, \> 100,000/µl thrombocytes
  2. renal function: creatinin \< 1.5mg %
  3. hepatic function: GOT \</= 2.5 x UNL
  4. bilirubin: \< 1.5mg %
  5. metabolic parameters: Na, Ca, K in normal range, normal level of blood sugar
  6. blood coagulation: PZ \> 60%
* Concluded healing process following surgery
* \</= 4 weeks interval since surgery
* Informed consent

Exclusion Criteria:

* T4 carcinoma; inflammatory breast cancer, carcinoma in situ
* Simultaneous or sequential bilateral breast cancer
* Preoperative tumor-reducing radiotherapy or preoperative tumor-specific medical treatment
* Male patients
* Pregnancy or lactation
* Lacking compliance or understanding of the disease
* General contraindication against cytostatic treatment
* Serious concomitant disease preventing implementation of adjuvant therapy or regular follow-up
* Second carcinoma or status post second carcinoma (except for curatively treated squamous cell carcinoma of the skin or cervical carcinoma in situ)

Primary outcomes:
measure: Disease-free survival
measure: Overall survival
Secondary outcomes:
measure: Toxicities
Other outcomes:
Locations:
Study officials:
affiliation: Austrian Breast & Colorectal Cancer Study Group
name: Raimund Jakesz, MD
role: PRINCIPAL_INVESTIGATOR
References: