louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04014153: CI-AKI in Patients With Stable CAD and Comorbidities. Are we Doing Better?
Official title: The Impact of Comorbidity as a Risk Factor of Acute Kidney Injury (AKI) in Patients With Stable Coronary Artery Disease (CAD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stable Angina
Acute Kidney Injury
Contrast-induced Nephropathy
Keywords: acute kidney injury
coronary artery disease
contrast-induced acute kidney injury
comorbidity
CI-AKI
stable CAD
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 1023
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Both genders suffering from stable coronary artery disease, requiring percutaneous coronary intervention with intra-arterial iodinated contrast injection

Brief summary: Patients aged 18-89 with stable CAD and comorbidities receiving optimal medical treatment requiring PCI with iodinated contrast media.

The aim of the study is to assess the prevalence of contrast-induced AKI in 2012-2013 and 2017 cohorts and to evaluate the potential risk factors of CI-AKI to better guide the prevention in patients of higher risk.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Male and female patients 18 y. o. and older
* Verified stable coronary artery disease (CAD)
* Receiving optimal medical treatment and requiring percutaneous coronary intervention (PCI) with iodinated contrast media

Exclusion Criteria:

* Pregnancy, lactation
* Conditions affecting the prognosis (kidney failure, liver failure, oncology)
* Acute coronary syndrome (ACS)
* Stroke
* Contraindications to PCI
* Therapy with nephrotoxic drugs during the enrolment which cannot be stopped
* Refusal to sign the informed consent

Primary outcomes:
measure: Overall mortality
timeFrame: 5 years
measure: Cardiovascular mortality
timeFrame: 5 years
measure: Myocardial infarction
timeFrame: 5 years
measure: Stroke
timeFrame: 5 years
measure: GI bleeding
timeFrame: 5 years
measure: CABG
timeFrame: 5 years
measure: PCI
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Mironova OIu. [Contrast substances-induced nephropathy]. Ter Arkh. 2013;85(6):90-5. Russian.
citation: Mironova OI, Deev AD, Lakotka PG, Fomin VV. [Anemia as a risk factor of contrast-associated acute kidney injury]. Ter Arkh. 2020 Dec 15;92(12):48-52. doi: 10.26442/00403660.2020.12.200450. Russian.
citation: Mironova OI, Staroverov II, Sivakova OA, Deev AD, Fomin VV. [Contrast-induced acute kidney injury in chronic coronary artery disease patients with diabetes mellitus and obesity]. Ter Arkh. 2020 Nov 24;92(10):29-33. doi: 10.26442/00403660.2020.10.000753. Russian.
Clinical trial NCT06023251: Improving Nutritional Adequacy of ICU Survivors in a Prospective Interventional Way: the Bright Side Study
Official title: Does the Use of Supplemental Parenteral/Enteral Nutrition and/or Oral Nutrition Supplements Guided by Indirect Calorimetry Combined With Standard of Care Increases Energy Feeding Adequacy in Patients Who Survived Critical Illness?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malnutrition
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective is to increase caloric adequacy in patients who survived critical illness and are admitted to the ward by the use of a pro-active inclusive nutritional strategy including supplemental parenteral and/or enteral nutrition and/or oral nutritional supplements guided by indirect calorimetry.

This enables the investigators to address, within a clinical/scientific context, a recently demonstrated but until now relatively neglected 'dark side' of patient care at UZ Brussel, comparable to limited global evidence : iatrogenic malnutrition of ICU survivors. The use of a newly developed clinical pathway and nutrition strategy (oral, enteral and parenteral) led by a single SPoC (Single Point of Contact) for patients surviving intensive care will have a clear objective: to address the nutritional deficit in all patients.


Eligibility criteria: Inclusion Criteria:

* Adult ≥ 18 years
* ICU stay ≥ 7 days
* Ward stay ≥ 3 days
* Nutritional therapy not restricted
* Heterogeneous diseases

Exclusion Criteria:

* Patients \< 18 years
* ICU \< 7 days
* Ward stay \< 3 days
* Advanced Care Planning with impact on nutritional therapy
* Patients with palliative care
* Metabolic derangements such as metabolic diseases
* Pregnancy

Primary outcomes:
measure: Nutrition Adequacy
timeFrame: The adequacy will be calculated over the entire ward stay: from date of inclusion till 28 days later or death from any cause, whichever came first.
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UZ Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel, Vrije universiteit Brussel
name: Elisabeth De Waele, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00268151: Oxaliplatin in Combination With Capecitabine and Concurrent Radiation Therapy in Non-Small Cell Lung Cancer
Official title: Phase I Study of Oxaliplatin (Eloxatin) and Capecitabine (Xeloda) and Concurrent Radiation Therapy (XELOX-RT) in Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Carcinoma, Non-Small Cell Lung
Keywords: non-small cell lung cancer
oxaliplatin
capecitabine
XELOX-RT
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: James Graham Brown Cancer Center
name: Sanofi
First posted: 2005-12-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the most suitable dose of Oxaliplatin that can be safely given in combination with a low fixed dose of Capecitabine and a limited volume of radiation in patients with non-small cell lung cancer.

Detailed description: The purpose of this study is to determine the maximum tolerated dose (MTD) and the dose limiting toxicity (DLT) of Oxaliplatin in combination with Capecitabine and radiation in subjects with non-small cell lung cancer.

Eligibility criteria: Inclusion Criteria:

* histologically proven non-small cell lung cancer
* inoperable Stage III A or B NSCLC
* must have measurable disease by RECIST criteria
* no more than one prior chemotherapy for advanced disease
* ECOG Performance Status of 0, 1, or 2
* must be able to swallow pills or have a working gastric feeding tube and no evidence of malabsorption
* negative serum beta-HCG test and under active contraception (for females of childbearing potential)
* no known allergies to any of the study drugs
* willingness to sign an informed consent

Exclusion Criteria:

* women who are pregnant or breastfeeding
* ANC of less than 1500/mm3
* platelet count of less than 100,000/mm3
* estimated creatinine clearance of less than 50 cc/min (as measured by the Cockcroft-Gault equation)
* bilirubin of less than 2mg/dl
* SGPT of greater than 2x nl
* peripheral neuropathy of Grade 2 or higher
* more than one previous chemotherapy and previous radiation therapy to the chest
* a history of CHF/MI or other significant cardiac history within the last six months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
Study officials:
affiliation: James Graham Brown Cancer Center/ University of Louisville
name: Goetz H Kloecker, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03337451: Follow up Protocol to the Phase I/II Study of OPN-305 in Second-line or Third-line Lower Lower Risk Myelodysplastic Syndrome
Official title: Follow up Protocol to the Open Label Phase I/II Study OPN-305-106: A Prospective, Open Label Phase I/II Study to Assess the Safety and Efficacy of Cycles of Intravenously Infused Doses of OPN-305 in Second-line and Third-line Lower (Low and Intermediate-1) Risk Myelodysplastic Syndrome (MDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Myelodysplastic Syndrome
Lead sponsor: Opsona Therapeutics Ltd.
Sponsor class: INDUSTRY
Collaborators: name: M.D. Anderson Cancer Center
name: Montefiore Medical Center
name: H. Lee Moffitt Cancer Center and Research Institute
name: New York Presbyterian Hospital
First posted: 2017-11-09
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This protocol is a follow-up for patients receiving continuation of OPN-305 monotherapy treatment or combination treatment with azacitidine after completion of the dose confirming, dose expansion and HMA naïve parts of the main study OPN-305-106.


Eligibility criteria: Inclusion Criteria:

* Completion of the OPN-305-106 study
* Principal Investigator adjudicated efficacy response defined as either transfusion independence", "stable disease", "minor HI-E response" or "major HI-E response" and in the opinion of the Principal Investigator the patient may benefit from continued treatment with OPN-305 monotherapy or combination treatment with azacitidine.
* Provide written informed consent for the follow up protocol.

Exclusion Criteria:

* Refusal to provide written informed consent
* Withdrawal from the OPN-305-106 study prior to the final EOT visit
* Plan to be included into another interventional investigational study.
* Progression of disease

Primary outcomes:
measure: Incidence and types of Serious Adverse events
timeFrame: monthly through study completion, an average of 18 months
measure: monitor ongoing efficacy responses
timeFrame: monthly through study completion, an average of 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Research Site
state: Texas
Study officials:
References:
Clinical trial NCT06716151: A Study to Evaluate HB0034 in Healthy Chinese Adult Participants
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Single/mulit Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HB0034 in Adult Healthy Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy subjects
Lead sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose or multiple dose.

Detailed description: This study consisted of a single-dose escalation study and a multi-dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034 in Chinese healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects age ≥ 18 and ≤ 55 years.
* Body Mass Index (BMI) ≥ 17.5 and ≤ 32 kg/m².
* Normal ECG, blood pressure, respiratory rate, temperature, and heart rate, unless the investigator considers any abnormality to be not clinically significant.

Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.

Exclusion Criteria:

- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease.

Current or history of malignancy. • Family history of premature Coronary Heart Disease (CHD)

* History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).
* Pregnant or Breasting feeding subject. Women with a positive pregnancy test.
* Further exclusion criterias apply.

Primary outcomes:
measure: Percentage of subjects with drug related adverse events (AEs)
timeFrame: up to 113 days
Secondary outcomes:
measure: Cmax
timeFrame: Up to 113 days
measure: AUC0-infinity
timeFrame: up to 113 days
Other outcomes:
Locations:
city: Jinan
country: China
facility: Central Hospital affiliated to Shandong First Medical University
state: Shandong
Study officials:
References:
Clinical trial NCT04116151: Effectiveness of a Cream for Treatment of Dermatitis in Patients Whith Breast Cancer
Official title: Effectivenes and Safety of a Cream of Aloe Vera, Camomila and Tomillo (Alantel) for Profilaxis or Treatmment of Deratitis by Radiotheraphy in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCER
Keywords: BREAST CANCER
DERMATITIS
Lead sponsor: Hospital Universitario Reina Sofia de Cordoba
Sponsor class: OTHER_GOV
First posted: 2019-10-04
Enrollment: 78
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental, prospective, controlled clinical trial, with two parallel arms, double blind, multicenter study
Primary purpose: PREVENTION

Brief summary: It is intended to evaluate the effect of a marketed cream (Alantel®) based on natural products at high concentrations for the preventive and curative treatment (early stages) of radiation-induced dermatitis in cancer patients. For this, an experimental, prospective, controlled clinical trial, with two parallel arms, double blind, multicentre, will be carried out in which doctors will recruit 78 patients aged 14 years or over in Primary Care consultations. more, diagnosed with cancer, and having received radiotherapeutic cancer treatment, being randomly assigned to the experimental group (cosmetic cream) or the control group (emollient and moisturizing cream). The main variable will be the incidence rate of mild post-translational dermatitis and its improvement or cure once it has been established.


Eligibility criteria: Inclusion Criteria:

* Patients 14 years of age or older
* Diagnosed with cancer and who are or have recently received radiotherapy treatment.
* We will include patients without dermatitis or with acute dermal posttradiotherapy lesions, in grades 1 and 2.

Exclusion Criteria:

* Patients with dermal lesions in grade greater than 2.
* Skin cancer invasion or distant tumor metastasis.
* Concurrent chemotherapy with RT, severe / extensive burns, moisture, erosion or suppuration in the skin, history of connective tissue disorders, severe mental disorder (dementia, drug addiction, etc.).
* History of hypersensitivity reaction to any of the ingredients of the studio cream.
* Participants involved in other clinical trials within that month.

Primary outcomes:
measure: Incidence of radiation-induced dermatitis
timeFrame: three weeks
measure: Analog visual scale
timeFrame: three weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: University of Cordoba
Study officials:
References:
Clinical trial NCT05196451: Short-time Intervention in Post-Covid Syndrome Syndrome (SIPCOV): A Pragmatic Randomised Controlled Trial
Official title: Short-time Behavioural Intervention in Post-Covid Syndrome (SIPCOV): A Pragmatic Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 314
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The present study is a 2-arm pragmatic randomised controlled trial (RCT) in which 310 patients who suffer from post-Covid syndrome are randomised to either a short-time outpatient-based rehabilitation program (the intervention) or care as usual in a 1:1 ratio. Assessments will take place immediately before randomisation (T0), after intervention or care as usual (T1), and 6 months after T1 (T2). Patients will be recruited from General Practitioners (GP's) as well as social media and self-referral to the involved institutions.


Eligibility criteria: Inclusion Criteria:

* Fulfils pragmatic diagnostic criteria of idiopathic post-Covid syndrome: a) Confirmed acute Covid-19 by a positive PCR for SARS-CoV-2; b) Persistent symptoms at least 3 months following acute Covid-19 without symptom-free interval; c) Functional disability to an extent that interrupts all or a majority of normal activities (such as work/school attendance, physical exercise, social activities, etc.)
* Lives in one of the following Norwegian counties: Oslo, Viken, Innlandet, Vestfold og Telemark, Agder
* Informed consent to participation

Exclusion criteria

* Other chronic illnesses or demanding life situations that might explain persistent symptoms and disability
* Sustained organ damage (lung, heart, brain) following acute, serious Covid-19
* Bedridden
* Insufficient command of Norwegian language

Primary outcomes:
measure: Physical Functioning
timeFrame: Immediately after intervention (time T1)
Secondary outcomes:
measure: Fatigue
timeFrame: Immediately after intervention (time T1)
measure: Fatigue
timeFrame: At 12 months follow-up (time T2)
measure: Depression/anxiety
timeFrame: Immediately after intervention (time T1)
measure: Depression/anxiety
timeFrame: At 12 months follow-up (time T2)
measure: Adverse effects
timeFrame: Immediately after intervention (time T1)
measure: Adverse effects
timeFrame: At 12 months follow-up (time T2)
measure: Physical Functioning
timeFrame: At 12 months follow-up (time T2)
measure: Recovery from PIFS
timeFrame: Immediately after intervention (time T1)
measure: Recovery from PIFS
timeFrame: At 12 months follow-up (time T2)
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Vegard Bratholm Wyller
Study officials:
affiliation: University Hospital, Akershus
name: Vegard B Wyller
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02355951: Non-investigational Study to Evaluate Adenovirus Serotype 5 (Ad5) Neutralizing Antibodies (nAb) in Patients With Chronic Hepatitis B Virus (HBV) Mono-infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Hepatitis B
Lead sponsor: Transgene
Sponsor class: INDUSTRY
First posted: 2015-02-04
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SCREENING

Brief summary: Objectives:

Primary Objective:

To identify and preselect patients with chronic HBV mono infection, who are undetectable for anti-Ad5 nAb, currently being treated with nucleo(t)sides, for participation in the TG1050.02 Phase1/1b First in Man (FIM) study.

Secondary Objectives:

To assess the prevalence of undetectable anti-Ad5 nAb in chronic HBV mono-infected patients.

Methodology:

Patients with chronic HBV mono-infection, who are currently being treated with nucleo(t)sides for their HBV infection, will be enrolled in this study to measure Ad5 nAb levels. A single peripheral blood collection (4 mL) will be obtained and Ad5 nAb titers will be measured by a central laboratory using a newly validated assay.


Eligibility criteria: Inclusion Criteria:

* 18 through 65 years of age, inclusive
* Patients mono-infected with HBV and currently on HBV treatment for at least 2 years with either the nucleos(t)ide tenofovir (TDF) or entecavir (ENT)
* HBV DNA \< lower limit of quantification (LLOQ) (eg, HBV deoxyribonucleic acid (DNA) \< 20 IU/mL using the Roche COBAS TaqMan assay) within 6 last months
* Signed, written Independent Ethics Committee (IEC)-approved informed consent

Exclusion Criteria:

* Patients with either medical history or evidence of cirrhosis, as documented in the medical source, who had: a) any biopsy showing cirrhosis; or b) any transient elastography score of ≥ 10.5 kPa or Fibrosure® / FibroTest ® score of ≥ 0.48 with either test result within past 2 years.

Primary outcomes:
measure: Immunology analysis: Serum titers of Adenovirus serotypes 5 (Ad5) neutralizing antibodies (nAb)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
city: Grenoble
country: France
city: Lyon
country: France
city: Nancy
country: France
city: Paris
country: France
city: Strasbourg
country: France
city: Freiburg
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Mainz
country: Germany
city: München
country: Germany
Study officials:
References:
Clinical trial NCT03978351: The Role of Midkine in Diagnosis of Thyroid Cancer
Official title: The Role of Midkine in Diagnosis of Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 85
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will be conducted on 85 informed and consented individuals (according to the guidelines of ethical committee of faculty of Medicine, Assuit University ) The study will include 30 patients with thyroid cancer and 30 patients with benign thyroid diseases. The study will also include 25 aged matched apparently healthy individuals as a control group.

Brief summary: 1. Evaluation of the role of serum midkine in differentiating malignant from benign thyroid nodule
2. studying the level of serum midkine in relation to different thyroid cancer stages


Eligibility criteria: Inclusion Criteria:

patient with thyroid nodule

Exclusion Criteria:

1. Other known organ tumour
2. Chemothyrapy
3. Radiothyrapy c. Sample Size Calculation

Primary outcomes:
measure: serum midkine levels
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: