louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00095056: An Investigational Drug in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (0431-028)(COMPLETED)
Official title: Sitagliptin Study in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Chronic Renal Insufficiency
Keywords: Type 2 Diabetes Mellitus and Chronic Renal Insufficiency
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-11-01
Enrollment: 91
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: The purpose of this study is to determine the safety and tolerability of an investigational drug in patients with Type 2 Diabetes Mellitus (a specific type of diabetes) and Chronic Renal Insufficiency (inadequate kidney function).


Eligibility criteria: Inclusion Criteria:

* Patients who are at least 18 years of age diagnosed with type 2 diabetes mellitus (T2DM) (a specific type of diabetes).
* Patient has renal (kidney) insufficiency (inadequate kidney function)

Exclusion Criteria:

* Patient has had heart problems (such as a heart attack or chest pain) or stroke within the past 6 months or any condition or therapy which, in the opinion of the investigator, may not be in the patient's best interest to participate.
* Pregnant or breast feeding

Primary outcomes:
measure: Safety and Tolerability of Sitagliptin After 12 Weeks of Treatment
timeFrame: Week 0 through Week 12
Secondary outcomes:
measure: Safety and Tolerability of Sitagliptin Over 54 Weeks
timeFrame: Week 0 through Week 54
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Chan JC, Scott R, Arjona Ferreira JC, Sheng D, Gonzalez E, Davies MJ, Stein PP, Kaufman KD, Amatruda JM, Williams-Herman D. Safety and efficacy of sitagliptin in patients with type 2 diabetes and chronic renal insufficiency. Diabetes Obes Metab. 2008 Jul;10(7):545-55. doi: 10.1111/j.1463-1326.2008.00914.x. Epub 2008 Jun 1.
Clinical trial NCT03178656: A Trial to Compare Surgery With Sorafenib for Hepatic Celluler Cancer With Portal Vein Tumor Thrombosis
Official title: RCT Research: the Treatment of Hepatic Carcinoma With Portal Vein Branch Tumor Thrombosis (Resection or Sorafenib)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Portal Vein Tumor Thrombus
Keywords: sorafenib, operation
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: According to the guidelines recommended, only a few new targeted therapy drugs treatment, such as Sorafenib, is proper. It's 3 year survival rate is only 8% or so. According to our previous study, patients with hepatic carcinoma without portal vein tumor thrombus backbone and the contralateral tumor thrombus applyed tumor excision, along with tumor thrombus, the 3 year survival rate can reach 39.9%, the 5-year survival rate can reach 22.7%, curative effect is obviously better.


Eligibility criteria: Inclusion Criteria:

* 1. Clinical diagnosis of Hepatic cellular Carcinoma. 2. Patients with Portal Vein Tumor Thrombus (PVTT) of Hepatic cellular Carcinoma (HCC) detected by Serum Alpha Fetoprotein (AFP) and CT or MRI.

  3. Patients with a solitary tumor or multiple tumor which are resectable. 4. Patients without Hepatic vein or bile duct invasion and extrahepatic metastasis.

  5. Patients without surgical contraindication. 6. Patients with Child A or B liver function and indocyanine green retention rate at 15min (ICGR15) \< 10% before treatment.

  7. Laboratory examination: haemoglobin (Hb)\>100g/L, white blood cell (WBC) \> 3000/mL, PLT \> 8×10\*10/L before treatment.

  8. Patients without severe esophagealgastric varices before treatment. 9. Patients with HBV，HBV DNA≤100, 000 copy/mL. 10. All of the patients has written consent for this research.

Exclusion Criteria:

* 1.Patients with multiple tumors or vascular or bile duct invasion or extrahepatic metastasis.

  2.Patients with surgical contraindication. 3.Patients with Child C grade liver function before treatment. 4.Patients with other malignancy. 5.Patients treated with hepatic resection or TACE before this treatment. 6.Patients with severe esophagealgastric varices or refractory ascites or coagulation dysfunction before treatment.

Primary outcomes:
measure: overall survival of 1 year
timeFrame: 1 years
measure: overall survival of 3 year
timeFrame: 3 years
Secondary outcomes:
measure: time to progression
timeFrame: 3 years
Other outcomes:
measure: mortality
timeFrame: 30 days
Locations:
city: Wuhan
country: China
facility: Hepatic surgery center, Tong ji Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT00288756: The V-Tachogram:Decreasing Ventricular Arrythmias When Injecting Contrast in the Left Ventricle
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventricular Arrythmias
Keywords: arrythmias
Lead sponsor: Trillium Health Centre
Sponsor class: OTHER
First posted: 2006-02-08
Enrollment: 156
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study is to determine if increasing the linear rise rate of injection of x-ray contrast in the heart during left ventriculograms(part of a cardiac Catheterization procedure) will decrease the incidence of arrythmias and improve image quality?

Detailed description: The LV angiogram is performed frequently as part of the cardiac catheterization procedure. It is done by injecting a bolus of x-ray contrast into the ventricle through a pigtail catheter over a short period of time and observing the heart as it is pumped out. This provides information on regional wall motion abnormalities, ejection fraction, and mitral regurgitation. A common occurrence when performing a LV angio is frequent PVC's or V-tach during the injection, it has been suggested that ectopic's occurs about 54% of the time and that interpretability was limited 30% of the time(3) This is rarely serious and subsides at the end of the injection but the irregularity of the contractions does affect the diagnostic quality of the exam.

In an attempt to decrease the incidence of ventricular ectopic's during the LV angiogram Contrast injections with a greater linear rise increasing the injection duration to at least ½ the flow rate, greater than previous settings should decrease the tension and the contrast jets coming out of the catheter, decreasing the fling of the catheter at the initiation of the injection. Whether this affects the quality of the angiogram with a pig tail vs. a straight catheter will also need to be considered?

Eligibility criteria: Inclusion Criteria:

* Only ventriculograms that the operator deems necessary for the booked procedure will be considered. Only operators agreeing to the for mentioned settings will participate in the study. Patients will be randomized consecutively and should conclude in 3 to 4 weeks.

Exclusion Criteria:

* Patients with aortic valve disease, a-fib, and frequent benign ectopic beats and patients unable to follow instructions to stop breathing will be excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Trillium Health Centre
state: Ontario
Study officials:
affiliation: staff RN Trillium Health Centre
name: Peter Vandermyden, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04911556: the Effect of Probiotics on Aging Population
Official title: Study for the Effect of Probiotics on Aging Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Debility
Keywords: intestinal flora
Lead sponsor: Wuxi People's Hospital
Sponsor class: OTHER
Collaborators: name: Jiangnan University
First posted: 2021-06-03
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group served as a control group, while the other three groups are treated with different strains of bifidobacterium longum
Primary purpose: TREATMENT

Brief summary: This study intends to recruit aging population (over 65 years old). The investigators use 16 SrDNA sequencing technology, genome sequencing technology, metabonomics, random forest forecast model, analysing and selecting specific age-related intestinal flora. The investigators select probiotics slowing down senility. Then the investigators use the probiotics to intervene in the aging population. Finally the investigators observe whether the probiotics can delay aging.

Detailed description: This project plans to recruit the aging population (aged over 65 years old) and comprehensively analyze the public database and self-sequencing clinical big data by using 16 srDNA sequencing technology, metagenomic sequencing technology, metabonomics methods and Random Forest (R) prediction model to judge the key bacterial communities and related functional pathways related to aging.Based on the analysis results, the probiotics with the potential to alleviate aging were selected for intervention evaluation of aging population. This topic aims to explore the change process of intestinal flora structure and composition related to aging process.Identify the key intestinal bacteria genera/species/strains associated with aging, and target the pathway and metabolic characteristic spectrum of the key bacterial communities associated with aging;And select and breed specific intestinal bacterial strains related to aging.The aim is to reduce the age-related metabolic abnormalities and chronic inflammation, reduce medical treatment, rationally allocate medical resources, reduce medical costs and improve the quality of life.

Eligibility criteria: Inclusion Criteria:

1. Over 65 years old
2. Frail scale score above 3 points

Exclusion Criteria:

1. Severe impairment of liver and kidney function
2. The tumor is advanced and life expectancy is less than 2 years
3. Severe cognitive impairment and inability to cooperate
4. Unable to give informed consent
5. Have participated in other study before

Primary outcomes:
measure: Points of probiotics intervention in aging population
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wuxi People's hospitial
name: Kan Hong, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04849156: Spermatozoa Morphology Selection by Thermotaxis
Official title: Sperm Selection by Thermotaxis: a Novel Technique to Enhance Assisted Reproductive Technologies' Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Male Infertility
Keywords: Spermatozoa selection
Thermotaxis
Testicular and sperm biology
Lead sponsor: Instituto Valenciano de Infertilidade de Lisboa
Sponsor class: NETWORK
First posted: 2021-04-19
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10 male sperm donors.

Brief summary: This study aims to eventually assess the usefulness of thermotaxis for sperm selection in routine clinical practice.

Detailed description: As the world's total fertility rate decline, every year more couples require assisted reproductive technologies (ART) in order to achieve their desire to become parents. However, these techniques are not guaranteed solutions and still many couples with unexplained infertility fail to conceive. One of the reasons might be the relative selection of spermatozoa for the following ART. To minimize a poor selection made by the operator and to standardize spermatozoa selection, we suggest a new method might be used in combination with the routine spermatozoa selection techniques.

Thermotaxis might be used in the ART setting as a tool to select the best spermatozoa as human spermatozoa after capacitation responds positively to a temperature gradient change. Moreover, this might be the possible navigation mechanism of spermatozoa in the female genital tract. We hypothesize that spermatozoa selected by thermotaxis behavior might increase the morphologically normal spermatozoa number in the cohort used during ART.

The aim of this study is to evaluate if thermotaxis is a good method for selecting morphologically normal sperm for ART.

Eligibility criteria: Inclusion Criteria:

* Age: ≥18 and \<40 years old.
* Spermatozoa concentration \>15 x 10⁶ /mL in all sperm analysis performed in the last 24 months.
* Spermatozoa mobility \>32% in all sperm analysis performed in the last 24 months.
* Spermatozoa morphology \>4% in all sperm analysis performed in the last 24 months.
* Signed and dated informed consent

Exclusion Criteria:

* Use of antibiotics, intravenous illicit drugs, chemotherapy or radiotherapy usage in the last 3 months.
* Active smoking (during the preceding 12 months).
* More than 3 days prior to the last ejaculation.

Primary outcomes:
measure: Percentage of normal spermatozoa morphology
timeFrame: 11 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Instituto Valenciano de Infertilidade de Lisboa
Study officials:
affiliation: Instituto Valenciano de Infertilidade de Lisboa
name: Kadir Guleresi, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01437956: KL-6 Protein as a Biomarker of Lung Injury in Viral Bronchiolitis
Official title: Acute Bronchiolitis in Infants: Analysis of a Biomarker of Epithelial Lung Injury - Clinical and Virological Correlation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Viral Bronchiolitis
Keywords: Calcineurin
Bronchiolitis
Epithelial lung injury
Rhinovirus
Respiratory Syncytial Virus
Asthma
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2011-09-21
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: infants aged under 1 year

Brief summary: Serum KL-6 protein has been described as a biomarker of epithelial lung injury in Respiratory Syncytial Virus bronchiolitis. The investigators can imagine that epithelial injury intensity has consequences on immediate and later respiratory prognosis. Furthermore, this prognosis seems to be different according to the respiratory causative virus. The investigators propose to study, during an epidemic season, the correlation between KL-6 levels and clinical severity, and the type of viral infection.

Detailed description: Prospective, monocentric, case-control and transversal study Primary end-point: correlation between serum KL-6 level and severity of the bronchiolitis, evaluated by a clinical scoring system established at the time of the admission in Paediatric Emergency Unit Secondary end-points: respiratory virus detected by EIA and RT-PCR, phylogenetic study of rhinovirus, length of hospitalisation, immediate morbidity and mortality, risk of asthma at the age of three years old.

Eligibility criteria: Inclusion Criteria:

* Cases: Inaugural acute bronchiolitis in infant aged under 1 year; bronchiolitis is defined by rhinorrhea and/or cough, dyspnea, associated with clinical or radiological distension, wheezing or crackling or brake expiratory.
* Controls: Infant aged under 1 year with blood sample test performed for a non-infectious disease (preoperative assessment)

Exclusion Criteria:

* Cases: bronchopulmonary dysplasia, prematurity, cystic fibrosis, immunodeficiency, primary ciliary dyskinesia, congenital cardiopathy, use of corticotherapy the week between inclusion
* Controls: infectious documented disease, respiratory symptoms

Primary outcomes:
measure: KL-6 rate
timeFrame: At day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU Estaing
name: André LABBE, PU PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01999556: LCI-HEM-SPEC-001: Tissue Collection for Genetic Analysis of Acute Myelogenous Leukemia
Official title: LCI-HEM-SPEC-001: Tissue Collection for Familial Acute Myelogenous Leukemia Genetic Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia, Myelogenous, Acute
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2013-12-03
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients must have a diagnosis of acute myelogenous leukemia. Family members of patients with acute myelogenous leukemia may be enrolled.

Brief summary: The purpose of this study is to obtain high quality specimens for molecular studies for the identification and characterization of genetic mutations involved in the pathogenesis of familial myeloid malignancies. Specimens obtained will be de-identified, linked to basic clinical data, and sent to Washington University (Division of Oncology, St. Louis, MO) for molecular analyses. Some specimens sent to Washington University may also be used for quality control analyses.

Detailed description: This is a specimen collection study for patients receiving standard of care treatment for AML. Specimens collected will be 1) bone marrow biopsy and aspiration, 2) peripheral blood, 3) skin punch biopsy, and 4) oral rinse. Collection of these specimens will be at timepoints determined by the patient's standard of care and their physician Investigator.

Eligibility criteria: Inclusion Criteria

* Patients must have a diagnosis of acute myelogenous leukemia.
* Family members of patients with acute myelogenous leukemia may be enrolled.
* Informed consent must be provided by the patient or his/her legal guardian in accord with the practices of Levine Cancer Institute and Atrium Health.

Exclusion Criteria

* Known infection with Hepatitis B or C, HTLV, or HIV.

Primary outcomes:
measure: Number of participants with the mutation for acute myelogenous leukemia.
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Lawrence Druhan, PH.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00338156: Observational Study of the Remodelling Process Following Myocardial Infarct
Official title: Assessment of the Relationship Between Collagen Turnover, Left Ventricular Remodelling and Myocardial Scarring Assessed by Cardiac Magnetic Resonance and Neurohumoral Activation in Patients With Previous Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Myocardial Infarct
Keywords: Left Ventricle Remodelling
Collagen markers
Neurohormones
Cardiac MRI
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: Helse Vest
name: Amersham Buchler, GmbH & Co KG
First posted: 2006-06-20
Enrollment: 119
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with risk of heart failure secondary to myocardial infarct.

Brief summary: This study will assess the relationship between collagen turnover, neurohormonal activation, scarring and left ventricle remodelling in patients 3 years following a myocardial infarction.

Detailed description: A multinational trial compared losartan vs. captopril in 5477 postinfarction patients with symptoms of heart failure and/or evidence of left ventricular dysfunction. The trial was terminated in 2002 and the results of the main trial have been published. In this trial, a collagen and neurohumoral substudy was performed to assess the importance of collagen turnover in this population. A total of 235 patients were included from 18 centres. Blood was taken at randomisation, 1 month, 1 year and 2 years.

The present study will recruit surviving patients among the 119 individuals that were randomised to the neurohumoral substudy at the Stavanger University Hospital. The study will assess the relationship between collagen turnover, neurohormonal activation, scarring and left ventricle remodelling in these patients about 3 years following the index myocardial infarction.

The data collected at the 3-year follow-up visit will be compared to data from the initial study.

Eligibility criteria: Inclusion Criteria:

* Participation in the previous neurohormonal substudy of the OPTIMAAL trial
* Willingness to participate in the present study and ability to understand and sign the written informed consent

Exclusion Criteria:

* Myocardial infarction within 3 months of visit 1.
* Significant primary valve disease, confirmed by ECHO cardiography,
* Autoimmune disease likely to cause an increase in collagen turnover
* Active cancer disease
* Immunosuppressive treatment,
* Significantly reduced liver function
* Contraindications for performing a cardiac MRI scan (including claustrophobia, implanted ferromagnetic devices or known allergic reactions to Omniscan™).
* Inability to cooperate during the 1 month follow up period.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
affiliation: Helse Stavanger HF
name: Kenneth Dickstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: