louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05738915: Role of C-Reactive Protein /Albumin Ratio in Evaluation of Disease Activity in Patients With Inflammatory Bowel Disease
Official title: Role of C-Reactive Protein /Albumin Ratio in Evaluation of Disease Activity in Patients With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - patients with IBD which included Crohn disease and Ulcertive colitis patients above age 18 years old.

Brief summary: Role of C-Reactive Protein /Albumin Ratio in evaluation of Disease Activity in Patients with Inflammatory Bowel Disease.

Detailed description: Inflammatory bowel disease (IBD) is defined as a life long chronic inflammatory disease affecting the gastrointestinal tract resulting from the interaction of environmental and genetic elements, has been a global healthcare problem with a steadily increasing incide IBD is mainly composed of two different bowel-relapsing disorders, including Crohn's disease (CD) and ulcerative colitis (UC).

Early detection of the disease activity of IBD is of great significance for the treatment of this disease, which can effectively prevent complications and therefore improve prognosis as well as quality of life. In current clinical practice, commonly used noninvasive biomarkers such as C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), are considered to be important for both early diagnosis and accurate monitoring of the disease activity in IBD patients.

The C-reactive protein/albumin ratio (CAR) is indicative of the balance between inflammation and nutritional status, making it an excellent marker for assessing disease activity in patients The disease activity of UC and CD patients was evaluated by the Mayo score and Crohn disease activity inde (CDAI).

Eligibility criteria: Inclusion Criteria:

* patients with IBD which included Crohn disease and Ulcertive colitis patients above age 18 years old.

Exclusion Criteria:

* concurrent infections, liver cirrhosis, hematological diseases, heart failure, malignancies, autoimmune diseases, or congenital or acquired immunodeficiencies

Primary outcomes:
measure: CRP/Albumin ratio in IBD
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00033215: A Phase 1 Study of S-3304 in Patients With Solid Tumors
Official title: A Phase 1 Study of S-3304 in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: neovascularization
matrix metalloproteinases
antiangiogenesis
type IV collagenases
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2002-04-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Four dose levels were evaluated sequentially in separate groups of 6 to 8 patients: 1,600 mg/d (800 mg BID, Dose Level1 (DL1)), 3,200 mg/d (1,600 mg BID, DL2), 4,800 mg/d (2,400 mg BID, DL3), and 6,400 mg/d (3,200 mg BID, DL4). There was no intrapatient dose escalation.
Primary purpose: TREATMENT

Brief summary: To determine the maximum tolerated dose and safety profile of S-3304 in patients with biopsy accessible cancer who have failed previous therapy or to whom no standard therapies are available. To determine the pharmacokinetic profile of S-3304 in this patient population


Eligibility criteria: Inclusion criteria:

* Biopsy proven diagnosis of solid tumor(s) with biopsy accessible lesion(s)
* Must be able to tolerate oral medication Exclusion criteria
* Patients with other serious illnesses
* Patients who are receiving treatments

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Tampa
country: United States
facility: H. Lee Moffitt Concer Center and Research Institute
state: Florida
city: Buffalo
country: United States
facility: Roswell Park Cancer Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
References:
citation: Chiappori AA, Eckhardt SG, Bukowski R, Sullivan DM, Ikeda M, Yano Y, Yamada-Sawada T, Kambayashi Y, Tanaka K, Javle MM, Mekhail T, O'bryant CL, Creaven PJ. A phase I pharmacokinetic and pharmacodynamic study of s-3304, a novel matrix metalloproteinase inhibitor, in patients with advanced and refractory solid tumors. Clin Cancer Res. 2007 Apr 1;13(7):2091-9. doi: 10.1158/1078-0432.CCR-06-1586.
Clinical trial NCT01376115: Drug Use Investigation for ARRANON G (Nelarabine) Injection 250mg
Official title: Drug Use Investigation for ARRANON G (Nelarabine) Injection 250mg
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-06-20
Enrollment: 343
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with the following diseases in Japanese adults and children

1. T-cell acute lymphocytic leukemia (T-ALL)
2. T-cell lymphoblastic lymphoma (T-LBL)

Brief summary: To investigate safety and efficacy on Japanese subjects treated with nelarabine injection for intravenous use in clinical settings of the following diseases:

1. T-cell acute lymphocytic leukemia (T-ALL)
2. T-cell lymphoblastic lymphoma (T-LBL) Also, "any adverse events involving neurological disorder, hypotension, and blood disorder and their details" are to be investigated as an item of particular concern. In addition, subject outcome (alive or dead) at one year after the start of treatment will also be investigated.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of T-cell acute lymphocytic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL)

Exclusion Criteria:

* Subjects with hypersensitivity to nelarabine

Primary outcomes:
measure: The number of adverse events in Japanese subjects treated with nelarabine based on prescribing information under the conditions of general clinical practice.
timeFrame: 1 year
measure: Any incidence of adverse events related to neurological disorder, hypotension, and blood disorder and their details
timeFrame: 1 year
Secondary outcomes:
measure: Outcome (alive or dead) at one year after the start of treatment
timeFrame: 1 year
Other outcomes:
Locations:
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00154115: Levosimendan in High Risk Heart Valve Surgery
Official title: Efficacy of Levosimendan in Cardiac Failure After Heart Valve Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Keywords: heart failure
levosimendan
cardiac surgery
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, randomized, double blind study investigating the efficacy of levosimendan in heart failure after cardiac surgery.

Study hypothesis: Levosimendan diminishes the need for adrenergic inotropic drugs and morbidity and may improve survival after heart valve surgery.

Detailed description: 200 patients are prospectively randomized in a double blind study investigating the efficacy of levosimendan in heart failure after cardiac surgery. Levosimendan/placebo is administered as 24 hour continuous infusion beginning after anesthesia induction. Primary endpoint being adrenergic inotrope need after cardiopulmonary bypass and secondary endpoints hospital and 6-month mortality and major organ failure.

Eligibility criteria: Inclusion Criteria:

Eligible for cardiac valve or combined CABG and cardiac valve surgery:

* Clinical signs of cardiac insufficiency

Exclusion Criteria:

* Endocarditis

Primary outcomes:
measure: Heart failure necessitating inotropic drug administering after heart valve surgery
timeFrame: Postoperative hospital period
Secondary outcomes:
measure: Hospital morbidity and mortality
timeFrame: Postoperative hospital period
measure: Postoperative mortality at six months
timeFrame: Six months postoperatively
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
affiliation: Kuopio University Hospital
name: Pasi K Lahtinen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04852315: Acute Caffeine Ingestion on Futsal Performance
Official title: Effects of Acute Caffeine Ingestion on Futsal Performance in Sub-elite Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caffeine
Placebo
Lead sponsor: Universidad Francisco de Vitoria
Sponsor class: OTHER
Collaborators: name: Universidad Rey Juan Carlos
name: Universidad Miguel Hernandez de Elche
name: University of Beira Interior
First posted: 2021-04-21
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Caffeine supplementation has been recognized such as an useful strategy for improving performance in intermittent sports, however caffeine ingestion in futsal has been barely studied. In this randomized placebo-controlled study, we investigated the effects of acute caffeine supplementation in improving neuromuscular performance and physical match activity in futsal players.

Detailed description: To date, no previous investigation has studied the effect of acute caffeine ingestion on futsal performance during futsal-specific testing and during a simulated match. Therefore, the aim of this investigation was to establish the effects of acute caffeine intake on futsal-specific tests (e.g. futsal kicking velocity) and match-play running performance in male futsal players.

Eligibility criteria: Inclusion Criteria:

* Sub-elite men futsal players

Exclusion Criteria:

* Intolerance to caffeine,
* Suffering from any chronic pathology or an injury in the month prior to the investigation
* Use of medicines or dietary supplements during the study.

Primary outcomes:
measure: Changes in futsal match-play demands (m/min)
timeFrame: 48-hours
Secondary outcomes:
measure: Changes in maximal jump height (cm)
timeFrame: 48-hours
measure: Changes in 20-m sprint test (s)
timeFrame: 48-hours
measure: Futsal kicking velocity and accuracy test (km/h)
timeFrame: 48-hours
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Francisco de Vitoria
Study officials:
affiliation: Universidad Francisco de Vitoria
name: Alvaro L López Samanes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lopez-Samanes A, Moreno-Perez V, Travassos B, Del Coso J. Effects of acute caffeine ingestion on futsal performance in sub-elite players. Eur J Nutr. 2021 Dec;60(8):4531-4540. doi: 10.1007/s00394-021-02617-w. Epub 2021 Jun 16.
Clinical trial NCT01767415: Intra-operative Use of Indigo Carmine Dye for the Delineation of Ill Defined Tumor Borders Using Stereotactic Injection
Official title: Intra-operative Use of Indigo Carmine Dye for the Delineation of Ill Defined Tumor Borders Using Stereotactic Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Brain Tumors With Ill-defined Margins
Keywords: brain tumor
resection
indigo carmine dye
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2013-01-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 investigate whether stereotactic indigo carmine injection can safely increase the extent of tumor resection.

Detailed description: Low grade gliomas are brain tumors with usually poorly defined borders between tumor and normal brain. This characteristic of low grade gliomas makes the gross total resection of the tumor extremely difficult. Nevertheless, several studies have demonstrated that the risk of recurrence and progression into a more malignant tumor can be decreased with a more aggressive surgical resection. An aggressive attempt to achieve a gross total resection may result in the resection of normal brain and therefore neurological injury. For this reason, the more common error is to subtotally resect the tumor leaving significant volumes of tumor behind. Many techniques have been introduced to safely increase the extent of resection, since the extent of resection is associated with a higher survival rate. Each one of these techniques has several shortcomings. The current study will assess whether the intraoperative stereotactic injection of the indigo carmine at the tumor margins helps to safely increase of extent of tumor resection. In the first step of the study the safety and the correlation between resection of stained tissue/extend of tumor resection will be assessed. If the results are satisfactory, then the second step will ensue. In the second step we will assess the utility of indigo carmine as an additional adjunct to guide tumor resection.

Eligibility criteria: Inclusion Criteria:

* Subjects with gliomas or other tumors that may have ill defined margins during the operative resection.

Exclusion Criteria:

* Subjects with a contraindication for brain MRI scan. Subjects who are pregnant, younger than 18 years old or have a contraindication for indigo carmine are excluded as well

Primary outcomes:
measure: Extent of Resection
timeFrame: 48 hours
Secondary outcomes:
measure: Absence of Complications After Injection
timeFrame: 30 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College Department of Neurological Surgery
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Theodore Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06863415: Study on the Enhancement of Intestinal and Immune Functions Through Probiotic Intervention
Official title: A Study on the Safety and Effectiveness of Bifidobacterium Longum Subsp. infantisBI45 in Improving Intestinal and Immune Functions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-07
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate the effectiveness and safety of Bifidobacterium longum subsp. infantis BI45 as a food supplement compared to a placebo in improving intestinal and immune functions in healthy adults.


Eligibility criteria: Inclusion Criteria:

1. Willing to undergo 3 follow-up visits during the intervention period Be willing to provide blood, urine and stool samples 2 times during the intervention period
2. Willing to self-administer probiotic or placebo once a day during the intervention period
3. Good eyesight, can read and write, can wear glasses
4. Have good hearing and be able to hear and understand all instructions during the intervention

Exclusion Criteria:

1. Digestive diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease)
2. Have a serious neurological condition (epilepsy, stroke, severe head trauma, meningitis in the last 10 years, brain surgery, brain tumor, prolonged coma - not including general anaesthesia)
3. Have received/are receiving treatment for the following mental disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder
4. Take medication for depression or low mood Internal organ failure (heart, liver or kidney failure, etc.)
5. Have received radiation or chemotherapy in the past
6. Have undergone a general anesthesia procedure/procedure within the past three years, or plan to undergo a general anesthesia procedure/procedure within the next 3 months during this trial period
7. Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past

Primary outcomes:
measure: Change in the concentration of antimicrobial peptides (LL-37 and calprotectin) in feces before and after intervention
timeFrame: Week 0 and Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan University of Technology
state: Henan
Study officials:
References:
Clinical trial NCT06125015: Unexpected ABR Results in Patients Suspected With Auditory Neuropathy Spectrum Disorder
Official title: Unexpected ABR Results in Patients Suspected With Auditory Neuropathy Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Auditory Neuropathy
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 11
Sex: ALL
Minimum age (years): 0
Maximum age (years): 46
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aimed to assess the clinical evaluations and potential underlying pathologies in patients diagnosed with Auditory Neuropathy Spectrum Disorder (ANSD) who exhibited unusual results in audiological tests. The research involved the retrospective analysis of audiological tests of 11 patients conducted by expert audiologists at Istanbul Medipol Mega Hospital between 2010 and 2020. These patients displayed abnormalities in their Auditory Brainstem Response (ABR) tests. The study sought to investigate patients with ANSD who presented atypical audiological findings, shedding light on the associated clinical aspects and potential causes of such anomalies.


Eligibility criteria: Inclusion Criteria:

* Presence of wave V with cochlear microphonics

Exclusion Criteria:

* Type B tympanogram

Primary outcomes:
measure: Measuring Hearing Thresholds with Electrophysiological Tests
timeFrame: 6 years
measure: Evaluating Middle Ear Pathologies
timeFrame: 6 years
measure: Evaluating Hearing Thresholds by Using Behavioral Tests
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00013715: Ozone and Rhinovirus-Induced Disease in Asthmatics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma
Rhinovirus
Ozone
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-03-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: In the U.S., morbidity associated with human rhinovirus (RV) infection represents a major health problem. In asthmatics, up to 80% of asthma exacerbations are associated with upper respiratory infections. Despite evidence that environmental oxidant pollutants, such as ozone, may increase the severity of viral disease, the mechanisms underlying such an effect have not been identified. This study will test the hypothesis that exposure of allergic asthmatic subjects to ambient levels of ozone directly enhances viral disease by increasing infectivity and intensifying virus-induced inflammation.

Detailed description: In mild asthmatics, the study will investigate: (1) if exposure to ozone will enhance the viral infective process in the nasal epithelium, (2) the effect of ozone exposure on RV-induced inflammatory gene expression, mediator release and inflammatory cell influx into the upper and lower airways, and (3) the interactive effects of ozone and RV on airway reactivity. This information will improve our understanding of the risk associated with oxidant pollutant exposure in this population of individuals in whom RV infection may represent a significant health concern.

Eligibility criteria: Subjects recruited will be non-asthmatic controls or mild allergic asthmatics using beta-agonists, mostly on an "as needed" basis. Selection criteria will include good general health by medical history and physical examination, no history of smoking, and the absence of respiratory infection in the preceding 6 week period. Subjects will undergo serologic testing and must have a negative test for neutralizing antibodies to RV16 to participate in all but one study of the project.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins School of Hygiene and Public Health
state: Maryland
Study officials:
References:
Clinical trial NCT03319615: The Effect of Fat Mass, Fat-free Mass and Resting Metabolic Rate on Energy Intake
Official title: Biological and Psychological Mediators of the Relationships Between Fat Mass, Fat-free Mass and Energy Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetitive Behavior
Keywords: Appetite
Energy Intake
Body Composition
Energy Expenditure
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The baseline non-intervention control arm only used in the present secondary data analysis
Primary purpose: BASIC_SCIENCE

Brief summary: The present study was based on secondary analysis using the non-intervention control conditions of five separate studies with common measures. The current analysis examine the indirect and direct effects of fat-free mass, fat mass and resting metabolic rate on energy intake in individuals at or close to energy balance.

Detailed description: The current analysis examine the indirect and direct effects of fat-free mass, fat mass and resting metabolic rate on energy intake in individuals at or close to energy balance.

The present study was based on secondary analysis using the non-intervention control conditions of five separate studies conducted between the dates of 1998 and 2007. In total, 242 subjects (114 males; 128 females; mean body mass index = 25.6 ± 5.0 kg/m2) were included. In these studies, body composition (air displacement plethysmography), energy expenditure (indirect calorimetry and flex heart rate) and energy intake (weighed dietary records) were measured using common procedures.

Eligibility criteria: Inclusion Criteria:

* Weight stable (weight change of \<2 kg in the previous three months)
* Non smoker
* Not dieting,
* No history of eating disorders,
* Free from disease

Exclusion Criteria:

* Taking medication known to effect metabolism or appetite
* Pregnant

Primary outcomes:
measure: Energy Intake- weighed dietary record method
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: University of Leeds
state: West Yorkshire
Study officials:
References: