louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03977077: Treatment of Advanced Gastrointestinal Tumors With Albumin Taxol
Official title: A Retrospective Clinical Study on the Efficacy and Safety of Injection Taxol (Albumin Binding Type) in the Treatment of Patients With Advanced Gastrointestinal Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Advanced Gastrointestinal Tumors
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2019-06-06
Enrollment: 100
Sex: ALL
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: The purpose of this study was to evaluate the safety and efficacy of domestic injection paclitaxel (albumin binding type) in patients with advanced digestive tract tumors,and to further explore the possible predictors of efficacy.In order to provide more effective chemotherapeutic drugs, prolong survival time and improve quality of life for patients with advanced digestive tract tumors.


Eligibility criteria: Inclusion Criteria:

1. Patients aged ≥18 years with advanced esophageal cancer, gastric cancer, pancreatic cancer and gallbladder (duct) confirmed histologically by albumin paclitaxel chemotherapy regimen;
2. ECOG PS 0-2；
3. Expected survival time ≥3 months;
4. According to RECIST1.1, at least one measurable lesion exists；
5. The level of organ function must meet the following requirements（1）Blood routine examination standards must be met：HB≥90 g/L；ANC≥1.5×109/L； PLT≥80×109/L；（2）Liver function should meet the following criteria TBIL≤1.5×ULN；AST≤2.5×ULN；（3）Renal function should meet the following criteria: CrCL≥60 ml/min；

Exclusion Criteria:

1. Pregnant or lactating women；
2. Had a history of other primary malignancies within 5 years, with the exception of cured basal cell skin cancer and cured cervical cancer;
3. Active brain metastasis or severe disease;
4. Grade 1 peripheral neuropathy (judged according to NCICTC standard for adverse reactions);
5. Patients with allergy to research drugs, albumin or previous allergies;
6. Severe mental or neurological disorders affecting the presentation or observation of adverse reactions;
7. The investigator considers that there is any condition that may impair the subject or cause the subject to fail to meet or perform the study requirements.

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: up to 2 year
Secondary outcomes:
measure: Objective remission rate (ORR)
timeFrame: up to 2 year
measure: Overall survival
timeFrame: up to 2 year
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
state: Henan
Study officials:
References:
Clinical trial NCT00300677: To Determine The Amount Of Voriconazole In The Brain After 2 Loading Doses And 3 Maintenance Doses Over 3 Days
Official title: Assessment Of Voriconazole Penetration Into The Brain By Fluorine-Magnetic Resonance Spectroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infections, Fungal
Keywords: Pharmacokinetics
Voriconazole
Magnetic Resonance Spectroscopy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: McLean Hospital. Belmont, MA.
First posted: 2006-03-09
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To determine the amount of voriconazole in the brain after 2 loading doses and 3 maintenance doses over 3 days and compare it to the amount of voriconazole in the plasma.


Eligibility criteria: Inclusion Criteria:

* Subjects must be willing and able to provide informed consent.
* Subjects must be willing and able to be confined at the Clinical Research Unit as required by the protocol.

Exclusion Criteria:

* Subjects with any condition affecting drug absorption.

Primary outcomes:
measure: Plasma Concentrations of Voriconazole
timeFrame: Day 3: pre-dose, 2 hours post-dose
measure: Brain Concentrations of Voriconazole
timeFrame: Day 3: pre-dose, 2 hours post-dose
measure: Plasma Concentrations of N-oxide Metabolite
timeFrame: Day 3: pre-dose, 2 hours post-dose
measure: Brain Concentrations of N-oxide Metabolite
timeFrame: Day 3: pre-dose, 2 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Henry ME, Bolo NR, Zuo CS, Villafuerte RA, Cayetano K, Glue P, Damle BD, Andrews E, Lauriat TL, Rana NS, Churchill JH, Renshaw PF. Quantification of brain voriconazole levels in healthy adults using fluorine magnetic resonance spectroscopy. Antimicrob Agents Chemother. 2013 Nov;57(11):5271-6. doi: 10.1128/AAC.00394-13. Epub 2013 Aug 12.
Clinical trial NCT06124677: Single Injection of Faricimab for nAMD With Persisting Fluid Despite Frequent Aflibercept Treatments
Official title: Anatomical and Visual Outcomes Following a Single Injection of Intravitreal Faricimab in Patients With Neovascular Age-related Macular Degeneration and Persisting Fluid Despite Frequent Aflibercept Treatments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neovascular Age-related Macular Degeneration
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 46
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with neovascular age-related macular degeneration (AMD)

Brief summary: The goal of this retrospective single-center chat review is to establish the efficacy and safety of a single dose of intravitreal faricimab (Vabysmo®) injection in patients with neovascular age-related macular degeneration (AMD), who were previously treated with aflibercept (Eylea®) and had persisting intraretinal or subretinal fluid despite frequent treatments.


Eligibility criteria: Inclusion criteria

* Presence of neovascular age-related macular degeneration (AMD) in the study eye
* \>50 years of age
* Previous intravitreal anti-VEGF treatment with aflibercept (Eylea®) or with aflibercept and ranibizumab (Lucentis®) in the study eye
* Minimum of 6 monthly aflibercept injections
* Persisting intraretinal or subretinal fluid or both, despite at least 3 consecutive monthly aflibercept injections in the study eye before switching to faricimab

Exclusion criteria

* Neovascular conditions other than AMD (e.g., choroidal neovascularisation due to other causes) or co-existence of other retinal disease in the study eye
* Significant optical media opacities that would result in poor imaging quality on OCT scans in the study eye
* Intraocular surgery in the study eye 3 months before or within 1 month after the treatment switch

Primary outcomes:
measure: Proportion of patients responding to the treatment switch
timeFrame: 4 weeks
Secondary outcomes:
measure: Durability of a single injection in cases of favorable treatment response without residual fluid
timeFrame: Up to 16 weeks
measure: Differences in patient characteristics between individuals responding and not responding to faricimab
timeFrame: 4 weeks
measure: Changes in visual acuity after the treatment switch
timeFrame: 4 weeks
measure: Changes in central retinal thickness after the treatment switch
timeFrame: 4 weeks
measure: Changes in pigment epithelium detachment (PED) height after the treatment switch
timeFrame: 4 weeks
Other outcomes:
measure: Frequency of ocular and systemic adverse events
timeFrame: 4 weeks
Locations:
city: Glostrup
country: Denmark
facility: Miklos Schneider
Study officials:
affiliation: Rigshospitalet Glostrup
name: Miklos Schneider, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01241877: Astaxanthin Supplementation in Cyclists
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Athletic Performance
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2010-11-16
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Background of the study:

Astaxanthin has been shown to be a powerfull anti-oxidant. Health benefits have been shown in animals and humans. Exercise enhancing effects have been shown in animals via enhancement of fat oxidation. We want to examine the effects of 4 weeks of astaxanthin supplementation on fat oxidation and cycling performance in trained cyclists

Objective of the study:

To test the hypothesis that 4 weeks supplementation with astaxanthin will improve fat oxidation and improve exercise performance in trained cyclists

Study design:

Double blind, placebo controlled study.

Study population:

Well trained cyclists between 18-30 years old

Intervention (if applicable):

astaxanthin (20 mg/day) or placebo for 4 weeks

Primary study parameters/outcome of the study:

performance on a time trial after 90 min steady state exercise.

Secundary study parameters/outcome of the study (if applicable):

substrate use plasma glucose plasma lactate plasma free fatty acid plasma astaxanthin

Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):

The risks involved in participating in this experiment are minimal. Astaxanthin has been shown to be safe. Insertion of the catheters in a vein is comparable to a normal blood draw and the only risk is of a small local haematoma.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Male
* Age between 18 and 30 years
* Endurance trained (≥3 sessions of endurance exercise per week)
* VO2 max ≥ 50 ml/kg/min
* Training history of more than one year of ≥3 sessions of endurance exercise per week
* BMI \<25 kg/m2

Exclusion Criteria:

* Use of medication
* Smoking

Primary outcomes:
measure: time trial performance
timeFrame: 4 weeks
Secondary outcomes:
measure: substrate use
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: LI
Study officials:
References:
citation: Klinkenberg LJ, Res PT, Haenen GR, Bast A, van Loon LJ, van Dieijen-Visser MP, Meex SJ. Effect of antioxidant supplementation on exercise-induced cardiac troponin release in cyclists: a randomized trial. PLoS One. 2013 Nov 19;8(11):e79280. doi: 10.1371/journal.pone.0079280. eCollection 2013.
Clinical trial NCT02149277: Gcsf Injection in Women With Repeated Implantaiton Failure
Official title: Effects of Exogenous Recombinant GCSF in Patients With Repeated Implantation Failure - A Randomized Single-blind Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Repeated Embryo Implantation Failure
Keywords: Infertility
IVF
Embryo transfer
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
First posted: 2014-05-29
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to see the impact of intrauterine injection of recombinant GCSF on pregnancy and implantation rate during IVF-ICSI (intracytoplasmic sperm injection) protocols as well as in frozen embryo transfer. In addition, following the injection, the level of G-CSF in the bloodstream will be verified.

Detailed description: Recently, scientists have been interested in G-CSF (Granulocyte - Colony Stimulating Factor) and the latter has seen its use grow in reproductive pathology.

G -CSF, a true center pivot, would act concurrently on oocyte quality and endometrial receptivity, improving:

* Immune tolerance
* The self-healing of oocyte chromosome abnormalities
* The adherence of the embryo

The injection of G-CSF molecule has been used in different circumstances. One of its uses, among others, is to help rebuild the immune system in patients undergoing chemotherapy. Some studies have been conducted in patients having embryo implantation problems; they have demonstrated improved rates of pregnancy and childbirth after treatment.

Eligibility criteria: Inclusion Criteria:

* Women between the ages of 18 and 37
* Indication of the Antagonist IVF protocol or indication of a substituted frozen embryo transfer
* Subjects with repetitive embryo implantation failure meaning: a history of 3 embryos transferred including frozen embryo without a positive pregnancy test for women 35 years and younger
* Subjects with repetitive embryo implantation failure meaning: a history of 4 embryos transferred including frozen embryo without a positive pregnancy test for women between the ages of 35 and 37.
* Negative repetitive implantation failure work up

Exclusion Criteria:

* Renal failure or cardiac failure
* Chronic neutropenia
* Past or present cancer history
* Sickle cell anemia
* Lithium treatment
* Voluntary withdrawal from the study
* Use of concomitant medication: DHEA (dehydroepiandrosterone ), CoQ10 (coenzyme Q10), Growth Hormone and Viagra

Primary outcomes:
measure: Dosage of G-CSF
timeFrame: up to 3 years
measure: Pregnancy and Implantation
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: Jacques Kadoch, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01958177: Clinical Study to Evaluate the Safety and Efficacy BMMNC in Cerebellar Ataxia
Official title: Clinical Study to Evaluate the Safety and Efficacy of Bone Marrow Derived Mono Nuclear Stem Cell (BMMNCs) in Cerebellar Ataxia .It is Self Funded (Patients' Own Funding) Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Cerebellar Ataxia
Keywords: stem cell
cerebellar ataxia
BMMNC
Lead sponsor: Chaitanya Hospital, Pune
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cerebellar ataxia is a complex motor disturbance, which, can occur as a result of many diseases and presents with symptoms of an inability to coordinate balance, gait, extremity and eye movements. Lesions to the cerebellum can cause dyssynergia, dysmetria, dysdiadochokinesia, dysarthria and ataxia of stance and gait. Deficits are observed with movements on the same side of the body as the lesion (ipsilaterally).


Eligibility criteria: Inclusion Criteria:

* Age limit: 18 -65
* Diagnosed as Cerebellar ataxia
* Willingness to undergo Bone marrow transplantation BMMNC.
* To give an informed consent as well as sign the required Informed Consent Form (ICF) for the study.
* willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.

Exclusion Criteria:

* Patients with pre-existing or current systemic disease such as lung , liver (exception: history of uncomplicated hepatitis A) gastrointestinal , cardiac, immunodeficiency (including HIV) or any other condition determined by history or laboratory investigation that could cause a neurological defect (including syphilis, clinically relevant polyneuropathy) etc.
* Women who are pregnant or lactating
* Chronic kidney disease due to autoimmune aetiology, connective tissue disease, amyloidosis and storage disorders.
* Suffering from Severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores.
* Positive test results for HIV and AIDS complex ,HCV , HbsAg and Syphilis

Primary outcomes:
measure: improve in INTERNATIONAL CO-OPERATIVE ATAXIA RATING SCALE
timeFrame: baseline and after 12 month
Secondary outcomes:
measure: Balance test
timeFrame: baseline and after 12 MONTH
measure: Tremor Rating Scale
timeFrame: baseline and after 12 MONTH
measure: quality of life
timeFrame: baseline and 12 months
Other outcomes:
Locations:
city: Pune,
country: India
facility: Chaitanya Hospital
state: Maharashtra
Study officials:
affiliation: Chaitanya Hospital
name: ANANT E BAGUL, MS ORTHO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01029977: Imaging Modality Effects on the Multi-dimensional InfraRed Analysis (MIRA) Technology
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer
Lead sponsor: Real Imaging Ltd.
Sponsor class: INDUSTRY
First posted: 2009-12-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects arriving for a mammography or breast ultrasound

Brief summary: The purpose of this study is to evaluate the effect of everyday practice modalities (mammography, US) on the MIRA technology.

Detailed description: The objective of the current clinical study is to collect sufficient MIRA imaging data of subjects arriving for a routine screening mammography, before and after they undergo the mammography. This is in order to reach a conclusion whether the the firm breast compression involved in the mammography procedure affects the performance of the MIRA technology. At the current stage of the development of the device, the goal of this clinical trial is in no way to arrive at a statistical analysis.

Eligibility criteria: Inclusion Criteria:

* Gender: female
* Age: 50 years and older
* Subjects summoned for a routine screening mammography, ultrasound, diagnostic mammography or breast biopsy.
* Subject who have signed an informed consent form.

Exclusion Criteria:

* Subjects who have had a mammography, ultrasound, and/or MRI examination performed on the day of the study, PRIOR to their FIRST imaging session with the RealImager.
* Subjects who have undergone any type of breast surgery throughout the 6 weeks preceding the study.
* Subjects who have had a breast biopsy performed throughout the 6 weeks preceding the study.
* Subjects who have undergone a mastectomy.
* Subjects who have undergone a lumpectomy.
* Subjects who have a large scar (causing breast deformation).
* Subjects who have previously undergone or are currently undergoing breast radiation therapy.
* Subjects who have previously undergone or are currently undergoing chemotherapy.
* Subjects with prior breast reduction surgery or breast augmentation surgery.
* Subjects who are pregnant.
* Subjects who are breast-feeding.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
References:
Clinical trial NCT05926947: OXXYNEA® GS: Study for Glycaemia Management
Official title: Evaluation of Two Plant Formulations for the Management of Glycemia on Pre-diabetic Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prediabetic State
Overweight
Lead sponsor: Fytexia
Sponsor class: INDUSTRY
First posted: 2023-07-03
Enrollment: 87
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind randomized parallel study
Primary purpose: PREVENTION

Brief summary: The aim of this study is to develop a proof of concept establishing a causal relationship between glycemia improvement through combination of polyphenols-rich botanical extracts or polyphenols-rich botanical extracts associated with white kidney bean extract and chromimum picolinate + zinc bisglycinate with chronic supplementation. Chronic glycemia improvement will be assessed by following the evolution of HbA1c, postprandial glucose and insulin kinetics, and questionnaires. The study design is double blinded randomized with 3 arms and 29 volunteers per arm.


Eligibility criteria: Inclusion Criteria:

* Fasting Plasma Glucose 75 - 125 mg/dL
* HbA1c: 5.-6.5 %
* Both sexes
* Overweight BMI range (25-30 Kg/m2)
* Age: 20-50 years old

Exclusion Criteria:

* Metabolic/Chronical disease
* Menopausal women
* Being pregnant, breastfeeding or wanting to have a baby
* Former obese with a history of yoyo effect
* Have been involved in a weight loss program in the past 12 months or subjected to weight reduction surgery
* Having started or quit smoking, having a high alcohol consumption
* Have in the past been in a long-term antibiotherapy (1 month or more) and/or a regular antibiotherapy in the past 12 months
* Allergy to olive, blackcurrant, pomegranate, grapefruit, white kidney bean, or corn.

Primary outcomes:
measure: HbA1c
timeFrame: 12 weeks
measure: Post prandial glycemia
timeFrame: 12 weeks
measure: Post prandial insulemia
timeFrame: 12 weeks
Secondary outcomes:
measure: Body weight
timeFrame: 12 weeks
measure: Dual-energy X-ray (DEXA)
timeFrame: 12 weeks
measure: Magnetic resonance imaging (MRI)
timeFrame: 12 weeks
measure: Short Form 12 (SF-12) questionnaire
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Guadalupe
country: Spain
facility: UCAM Universidad Católica San Antonio de Murcia
state: Murcia
Study officials:
affiliation: UCAM (Universidad Catolica San Antonio de Murcia)
name: Pedro Alcaraz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06844747: Postoperative Pain in Lumbar Disc Surgery
Official title: Comparison of the Ultrasound-guided Erector Spinae Plane Block and Wound Infiltration for Postoperative Pain Management in Lumbar Disc Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erector Spinae Plane Block
Wound Infiltration
Lumbar Disc Herniation
Postoperative Pain
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-02-25
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design was double-blind, prospective, randomized, and controlled, involving patients undergoing elective lumbar disc herniation surgery.The patients were randomized into two groups, the ESPB group (Group E) and the WI group (Group W), with 25 patients in each group, using a computer system. ESPB or WI was administered to the patients according to the randomization before awakening after the operation.
Primary purpose: OTHER

Brief summary: This study included 46 patients who underwent lumbar disc herniation surgery under general anesthesia. After the operation, US-guided ESPB was performed on Group E, and WI was performed on Group W. Postoperative pain was assessed, and the time to first analgesic requirement, total analgesic amount in 24 hours, and side effects were recorded. IBM SPSS Statistics 22 was used for statistical analyses.


Eligibility criteria: Inclusion Criteria:

* Anesthesiologists (ASA) physical status I-II

Exclusion Criteria:

* Patients with recurrent lumbar disc herniation,
* Obesity (body mass index \>35 kg/m2),
* Infection in the surgical site,
* Known local anesthetic drug allergy,
* Chronic pain, and coagulation disorders were excluded.

Primary outcomes:
measure: US-guided ESPB and WI on postoperative pain
timeFrame: postoperative 1 hour, 3 hours, 12 hours, and 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kartal Dr Lutfi Kirdar City Hospital
Study officials:
name: Irem DURMUS MD
role: PRINCIPAL_INVESTIGATOR
References: