louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06002893: The Antihypercholestrolemic Effect of a Combined Nutritional Supplementation of Standardized Extracts of Amla, Walnut, Red Yeast Rice and Olive
Official title: The Antihypercholestrolemic Pharmacological Effect of a Combined Supplement of Amla Fruit, Walnut Leaves, Red Yeast Rice, and Olive Fruit Extracts Leads to Improvement in Circulatory Levels of LDL-C and Remnant Cholesterol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemia
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2023-08-21
Enrollment: 221
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cholesfytol NG®) supplement treatment
Primary purpose: TREATMENT

Brief summary: Nutraceutical lipid-lowering interventions are becoming increasingly popular, particularly among patients who are intolerant or refractory to prescription statins, or who desire alternative non-conventional pharmacological treatment to manage their dyslipidaemia, whether they previously experienced statin intolerance or not. A growing body of preclinical and clinical evidence suggest that the amla (Emblica officinalis) red yeast rice (RYR), olive and walnut leaf extracts posses consideable hpolipidaemic pharmacological effects.

Detailed description: The present exploratory study aimed to assess the safety, efficacy, and patient's satisfaction of a combined supplementation of amla, red yeast rice, olive, and walnut leaf extracts (Cholesfytol NG®) on total cholesterol (TC), low-density lipoprotein - cholesterol (LDL-C), high-density lipoprotein - cholesterol (HDL-C), non-high-density lipoprotein - cholesterol (non-HDL-C), remnant cholesterol (RC) and triglycerides (TG) in hyperlipidaemic patients.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 21 years
* Both male or female
* Blood total cholesterol (TC) level ≥ 200 mg/dL
* Blood low-density lipoprotein cholesterol (LDL-C) level ≥ 130 mg/dL
* With or without myalgia and/or diabetes
* No prior treatment of cholesterol-lowering agents and/or patients whose cholesterol- lowering treatment did not allow them to reach LDL-C target
* Patients who had stopped their cholesterol-lowering treatment because of side effects including myalgia

Exclusion Criteria:

* Pregnant nor breastfeeding patients

Primary outcomes:
measure: Change in blood lipid profile
timeFrame: 2-months
measure: Change in blood lipid profile
timeFrame: 2-months
measure: Change in blood lipid profile
timeFrame: 2-months
measure: Change in blood lipid profile
timeFrame: 2-months
measure: Decrease in blood lipid profile
timeFrame: 2-months
Secondary outcomes:
measure: Rate of side effects
timeFrame: 2-months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Cliniques universitaires St-Luc and Institut de Recherche Expérimentale et Clinique (IREC), KU Leuven
Study officials:
References:
Clinical trial NCT00943293: Minor Histocompatibility Vaccination After Allogeneic Stem Cell Transplantation for Advanced Hematologic Malignancies
Official title: A Phase I/II Study of Vaccination Against Minor Histocompatibility Antigens HA1 or HA2 After Allogeneic Stem Cell Transplantation for Advanced Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Preleukemia
Myeloproliferative Disorders
Lymphoma
Myeloma
Graft Versus Host Disease
Keywords: GVHD
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2009-07-22
Enrollment: 1
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 is a clinical research study designed to evaluate whether the administration of a vaccine to patients after transplant consisting of a minor histocompatibility antigen (mHag peptide) mixed with G-CSF (a drug intended to stimulate the immune system) can stimulate increased graft versus leukemia (GVL) responses without causing graft-versus-host disease (GVHD).


Eligibility criteria: Inclusion Criteria:

* Relapsed or refractory acute myelogenous or lymphoid leukemia.
* Acute myeloid or lymphocytic leukemia in first remission at high-risk for recurrence.
* Chronic myelogenous leukemia in accelerated phase or blast-crisis.
* Chronic myelogenous leukemia in second or subsequent chronic phase
* Recurrent or refractory malignant lymphoma or Hodgkin's disease
* Multiple myeloma at high risk for disease recurrence.
* Chronic lymphocytic leukemia, relapsed or with poor prognostic features.
* Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features.

Exclusion Criteria:

* Clinical progression.
* Contra-indications for vaccination.

Primary outcomes:
measure: To determine in HLA A2 positive patients with hematological malignancies undergoing transplantation from HLA-identical donors, if HA1/2-peptide vaccinations can induce or enhance short- and long-term allogeneic HA1/2-specific T cell immunity.
timeFrame: 5 years
Secondary outcomes:
measure: To evaluate if HA1/2 peptide vaccination induces toxicity, especially acute GVHD after HLA-identical transplantation.
timeFrame: 5 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The Uniiversity of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Andrew Artz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00948493: Treatment Use of Generex Oral-lyn™ in Patients With Diabetes
Official title: An Open-Label Treatment Investigational New Drug (IND) for the Use of Generex Oral-lyn™ in Patients With Type 1 or Type 2 Diabetes Mellitus
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Keywords: diabetes
insulin therapy
Lead sponsor: Generex Biotechnology Corp.
Sponsor class: INDUSTRY
First posted: 2009-07-29
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The objective of this Treatment IND protocol is to provide Generex Oral-lyn™ to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available for treatment of diabetes, and who are not eligible to participate in the ongoing pivotal clinical trial (Protocol GEN-084-OL). This protocol is intended as a substitute for the Single Patient IND mechanism to obtain Generex Oral-lyn™.


Eligibility criteria: Study is closed

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05995093: The Proactive Diagnostic Value of Hemostatic Biomarkers in Disseminated Intravascular Coagulation
Official title: The Proactive Diagnostic Value of Hemostatic Biomarkers in Disseminated Intravascular Coagulation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Disseminated Intravascular Coagulation
Keywords: Thrombosis
Coagulation
Hemostatic Biomarkers
DIC
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 462
Sex: ALL
Minimum age (years): 18
Maximum age (years): 94
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults patients admitted to intensive care unit of Qilu Hospital from 1 January 2021 to 31 December 2022 were involved in our study.

Brief summary: The project was undertaking by Qilu Hospital of Shandong University, aiming to evaluate diagnostic performance of hemostatic biomarkers in disseminated intravascular coagulation.

Detailed description: Disseminated intravascular coagulation (DIC) is a life-threatening condition with high mortality, necessitating timely and accurate diagnosis for effective management. However, current diagnostic systems can not recognize DIC at its reversible phase, causing suboptimal treatment outcomes. Consequently, the current diagnostic criteria for DIC lacks earlier laboratory indicators. Therefore, the investigators aimed to assess the diagnostic potential of selected hemostatic biomarkers, including thrombin-antithrombin complex (TAT), soluble thrombomodulin (sTM), tissue plasminogen activator inhibitor complex (tPAI-C), α2-plasmin inhibitor plasmin complex (PIC) and anti-thrombin III (ATIII), in evaluating DIC, allowing for proactive diagnosis before the disease progresses into its irreversible phase.

Eligibility criteria: Inclusion Criteria:

* 18 years old, non-perinatal period, a hospitalization length of≥3 days.

Exclusion Criteria:

* primary hematologic diseases, decompensated liver cirrhosis, chemotherapy history.

Primary outcomes:
measure: whether DIC occured
timeFrame: From date of detecting hemostatic biomarkers until the date of first ISTH-DIC scores ≥5, assessed up to 7 days.
Secondary outcomes:
measure: whether death occurred
timeFrame: From date of admission until the date of death, assessed up to 5 months
Other outcomes:
Locations:
city: Ji'nan
country: China
facility: Miao Xu
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Miao Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00369993: Spacer Comparison In Adult Asthmatics
Official title: A Randomised, Open Label, Five-way Crossover Study to Assess the Systemic Exposure of Fluticasone Propionate and Salmeterol From SERETIDE/ADVAIR 250HFA MDI Alone and With AeroChamber-Max Spacer and VOLUMATIC Both in Their Washed and Unwashed States in Adult Subjects With Mild or Intermittent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: asthma
spacer
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Spacers are used by people with respiratory diseases who have problems using MDIs (metered dose inhalers). This study used fluticasone propionate/salmeterol to look at the pharmacokinetic profiles produced by different spacers in their washed and un-washed states.

Detailed description: A randomised, open label, five-way crossover study to assess the systemic exposure of fluticasone propionate and salmeterol from SERETIDE™/ADVAIR™ 250 HFA MDI without spacer and with AeroChamber-Max spacer and VOLUMATIC™ both in their washed and unwashed states in adult subjects with mild or intermittent asthma.

Eligibility criteria: Inclusion criteria:

* Non-smoking with a BMI of 19 - 30
* Diagnosed with mild or intermittent asthma and taking medication for it.

Exclusion criteria:

* Taking oral corticosteroids or inhaled fluticasone propionate
* Have certain medical conditions or are not otherwise healthy.

Primary outcomes:
measure: The pharmacokinetic profile of fluticasone propionate (in particular the area under the curve to time t and the maximum concentration)
Secondary outcomes:
measure: The pharmacokinetic profile of salmeterol and the time to maximum concentration of fluticasone propionate
Other outcomes:
Locations:
city: Wellington
country: New Zealand
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: This study has not been published in the scientific literature.
Clinical trial NCT05133193: Efficacy and Safety of 14-day Concomitant Therapy for Refractory Helicobacter Pylori Infection
Official title: Efficacy and Safety of 14-day Concomitant Therapy for Refractory Helicobacter Pylori Infection：A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Helicobacter Pylori Infection
Keywords: Concomitant Therapy,Rescue treatment
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the third-line treatment of Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates.

Detailed description: Helicobacter pylori infects half of the world's population. H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly increasing antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted.

Few published paper evaluated the efficacy of 14-day furazolidone containing concomitant therapy in the third line treatment. This study aims to propose a new concomitant therapy for the patients with three or more treatment failure, and then evaluates whether adverse effects are tolerable. .

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-70 years were recruited for this study if they had failed at least three rounds of anti- H. pylori therapies.

Exclusion Criteria:

* Patients treated with H2-receptor antagonist, PPI, vonoprazan, bismuth and antibiotics in the previous 4 weeks
* Patients with gastorectomy, acute GI bleeding and advanced gastric cancer,
* History of allergy to any of the drugs used in the study,
* Severe concomitant cardiovascular, respiratory, or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk,
* Currently pregnant or lactating,
* Severe neurologic or psychiatric disorders,
* Alcohol abuse or drug addiction,
* Patients with compliance lower than 90% in any previous treatment,
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Primary outcomes:
measure: Eradication rate
timeFrame: 6 month
Secondary outcomes:
measure: The rates of adverse events
timeFrame: 6 month
measure: Compliance
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02700893: Cerebral NIRS Profiles During Premedication for Neonatal Intubation
Official title: Cerebral NIRS Profiles During Premedication for Neonatal Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Premedication
Endotracheal Intubation
Cerebral Hypoperfusion
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Association Clinique Thérapeutique Infantile du val de Marne
name: Centre de Recherche Clinique du CHIC
First posted: 2016-03-07
Enrollment: 28
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Observational ancillary study of the PRETTINEO study (ClinicalTrials.gov Identifier: NCT01490580) which is a multicenter double blind randomized controlled trial comparing "atropine+propofol" vs "atropine+atracurium+sufentanil" as a premedication prior to endotracheal intubation of the neonate.

Primary outcome:

* Cerebral desaturation defined by a rScO2 delta \>20% from the baseline value (before premedication).
* Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication, calculated from rScO2 and pulse oximetry with the formula FTOE=SaO2 - rScO2/SaO2 .

Hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" does not increase the frequency of cerebral hypoxemia.


Eligibility criteria: Inclusion Criteria:

* Corrected age \< 45 weeks of gestational age
* Currently hospitalized in a neonatal intensive care unit
* Requiring semi-urgent or elective intubation
* Equipped with a reliable and permeable IV line
* Parental consent

Exclusion Criteria:

* Lack of parental consent
* Parental refusal
* Sedative or anesthetic treatment in the previous 24 hours
* Hemodynamic compromise defined as mean blood pressure\< corrected GA and/or refill time \> 3 seconds
* Upper airway malformation
* Life-threatening situation requiring immediate intubation
* Inclusion in another trial not permitting any other participation
* Impossibility to establish venous access
* Any contra-indication to any experimental drug
* Skin lesions or burns of the forehead

Primary outcomes:
measure: Cerebral desaturation
timeFrame: from 1 minute before to 60 minutes after the start of premedication
measure: FTOE (Fractional Tissue Oxygen Extraction)
timeFrame: from 1 minute before to 60 minutes after the start of premedication
Secondary outcomes:
Other outcomes:
Locations:
city: Créteil
country: France
facility: Hôpital intercommunal de Créteil
city: Toulouse
country: France
facility: Hôpital des enfants
Study officials:
affiliation: CHI Créteil
name: Meryl Vedrenne-Cloquet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHI Créteil
name: Xavier Durrmeyer, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Vedrenne-Cloquet M, Breinig S, Dechartres A, Jung C, Renolleau S, Marchand-Martin L, Durrmeyer X. Cerebral Oxygenation During Neonatal Intubation-Ancillary Study of the Prettineo-Study. Front Pediatr. 2019 Mar 1;7:40. doi: 10.3389/fped.2019.00040. eCollection 2019.
Clinical trial NCT06725693: Glucagon-like Peptide-1 Receptor PET/CT in GLP-1R Related Disease
Official title: Glucagon-like Peptide-1 Receptor PET/CT in GLP-1R Related Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: GLP1-R-related Disease
Tumor
Insulinoma
Positron Emission Tomography
Keywords: PET/CT
GLP1-R
Lead sponsor: Tianjin Medical University
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University General Hospital
First posted: 2024-12-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled Exendin 4 PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Brief summary: To evaluate the potential usefulness of 68Ga/18F-Exendin 4 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various GLP-1R-related disease patients.

Detailed description: Subjects with various GLP1-R-related disease patients underwent 68Ga/18F-Exendin 4 PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga/18F-Exendin 4 PET/CT were calculated.

Eligibility criteria: Inclusion Criteria:

- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled Exendin 4 PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcomes:
measure: Standardized uptake value (SUV)
timeFrame: 30 days
Secondary outcomes:
measure: Diagnostic efficacy
timeFrame: 30 days
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT01244893: Study of ACUVUE® ADVANCE® PLUS Contact Lenses.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-19
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare ACUVUE® ADVANCE® Plus contact lenses made prior to process qualification (prePQ) against the ACUVUE® ADVANCE® Plus lenses made after the process qualification (postPQ).


Eligibility criteria: Inclusion Criteria:

* The subject must be at least 18 years of age and no more than 39 years of age.
* The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study (minimum of 6 hours per day).
* The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
* Any cylinder power must be ≤ -0.75D.
* The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
* The subject must read and sign the Statement of Informed Consent.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

* Ocular or systemic allergies or disease which might interfere with contact lens wear.
* Systemic disease or use of medication which might interfere with contact lens wear.
* Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
* Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Pregnancy or lactation.
* Diabetes.
* Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
* Habitual contact lens type is toric, multifocal, or is worn as extended wear.

Primary outcomes:
measure: Visual Acuity (VA)
timeFrame: 6-8 days after lens wear
Secondary outcomes:
measure: Corneal Staining
timeFrame: 6-8 days after lens wear
measure: Limbal Redness
timeFrame: 6-8 days after lens wear
measure: Bulbar Redness
timeFrame: 6-8 days after lens wear
Other outcomes:
Locations:
city: Powell
country: United States
state: Ohio
city: Warwick
country: United States
state: Rhode Island
city: Salem
country: United States
state: Virginia
Study officials:
References: