louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04199910: 4beta-hydroxycholesterol in Cirrhosis
Official title: 4beta-hydroksikolesteroli Maksakirroosissa
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Cirrhosis, Liver
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cirrhosis, pneumonia, Crohn's disease or colitis ulcerosa treated in the ward 42 of the Oulu University Hospital

Brief summary: The aim is to evaluate the levels of oxysterols and especially 4beta-hydroxycholesterol in patients with liver cirrhosis. Three cirrhosis cohorts are recruited: patients treated with spironolactone, patients treated with rifaximin, patients without spironolactone or rifaximin. Also three other control cohorts are recruited: patients with pneumonia, patients with Crohn's disease, patients with ulcerative colitis. The effect of the cirrhosis and its medications spironolactone and rifaximin are compared to control groups.


Eligibility criteria: Inclusion Criteria:

* Patients with cirrhosis, pneumonia, Crohn's disease or colitis ulcerosa
* Treated in the ward 42 of the Oulu University Hospital

Exclusion Criteria:

* None

Primary outcomes:
measure: Blood 4beta-hydroxycholesterol concentration
timeFrame: At the time point of the blood collection - cross-sectional. One day.
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Oulu University Hospital
name: Janne Hukkanen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04552210: Mannose Binding Lectin Gene Polymorphism Versus Microbial Virulence in the Pathogenesis of Vulvovaginal Candidiasis
Official title: Mannose Binding Lectin Gene Polymorphism Versus Microbial Virulence in the Pathogenesis of Vulvovaginal Candidiasis in Egypt
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2020-09-17
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Married females in the reproductive age period. 2. Females complaining of vaginal discharge (whitish and scanty), itching, dyspareunia, pruritis, and signs of vulvovaginitis ie. erythema.

Brief summary: The vaginal mucosa is inhabited by both fungal and bacterial microorganisms which normally co-exist with the host in a tightly regulated and commensal manner.

Detailed description: Nevertheless, under certain circumstances, this co-existence can turn into a pathologic state followed by symptomatic disease

Eligibility criteria: Inclusion Criteria:

* 1. Married females in the reproductive age period. 2. Females complaining of vaginal discharge (whitish and scanty), itching, dyspareunia, pruritis, and signs of vulvovaginitis ie. erythema.

Exclusion Criteria:

* females who attended the same clinic in the same period, matched the cases regarding the age group, without having Candida infection as confirmed by culture of vaginal swabs.

Primary outcomes:
measure: the number of women who have mutation in MBL2 gene polymorphism
timeFrame: a month
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algezeera hospitaland National Research Centre ,Egypt
name: Mahmoud Alalfy
role: STUDY_CHAIR
References:
Clinical trial NCT05709210: Pilot Study on the Feasibility of Using Smartphone Data as a Diagnostic Marker for Alzheimer's Disease.
Official title: Pilot Study on the Feasibility of Using Smartphone Data as a Diagnostic Marker for Alzheimer's Disease.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Memory Disorders
Keywords: Alzheimer Disease
Smartphone
Memory Disorders
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
Collaborators: name: University of Poitiers
First posted: 2023-02-02
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will compare smartphone usage data between three groups of patients diagnosed with either a memory complaint, mild cognitive decline, or Alzheimer's disease.

Detailed description: Alzheimer's disease (AD) is the leading cause of dementia in the world. The first cognitive function affected is memory and then other cognitive systems are affected leading to a progressive loss of autonomy of the patient. Currently, the diagnosis of AD is made at too late a stage. Patients with memory complaints or mild cognitive decline (MCI) are particularly at risk of developing AD.

However, there is no clinical or paraclinical evidence to predict precisely this risk of progression to AD. Investigator's hypothesis is that there is an association between the evolution of smartphone use and the conversion of cognitive status to AD.

The purpose of this pilot study is to identify existing differences between smartphone use data of patients with a memory complaint or of patients MCI or with an AD. It is a study of 90 patients (30 patients with memory complaint, 30 with MCI and 30 with AD) with a collection of smartphone usage data during three months.

Eligibility criteria: Inclusion Criteria:

* Patient consulting in routine care in one of the CMRR
* No sensory impairment that may compromise smartphone use

Exclusion Criteria:

* Inability to perform MMSE or MMSE \< 20 ;
* Other neurodegenerative condition (Parkinson's disease, Lewy body disease, frontotemporal lobar degeneration, amyotrophic lateral sclerosis)
* Severe anxiety or depressive disorder HADS score ≥ 17
* Terminal phase of a severe disease
* Evidence of a lesion on MRI that may be involved in cognitive impairment

Primary outcomes:
measure: Comparison of a mathematical combination
timeFrame: Up to three months
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
References:
Clinical trial NCT01053910: Ramipril 10 mg/Day Prevention
Official title: A Multicentre Open, Non Comparative Study of the Safety of Ramipril (Tritace) 10 mg/Day in Prevention of Cardiovascular Events in High-risk Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atherosclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-01-22
Enrollment: 1012
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective is to investigate the safety of ramipril 10 mg/day used in prevention of cardiovascular events in high-risk patients, including the criteria of the HOPE study.


Eligibility criteria: Inclusion Criteria:

* History of coronary artery disease,
* Stroke
* Stable heart failure
* Peripheral vascular disease, or diabetes with at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low high-density lipoprotein cholesterol levels, cigarette smoking, or documented microalbuminuria).

Exclusion Criteria:

* Non stabilized or NYHA grade IV heart failure patients
* Hemodynamically significant primary valvular or outflow tract obstruction (eg. mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve)
* Constrictive pericarditis.
* Complex congenital heart disease.
* Syncopal episodes presumed to be due to uncontrolled life-threatening arrhythmias (asymptomatic cardiac arrhythmias including ventricular tachycardia are not an exclusion criterion).
* Planned cardiac surgery or angioplasty within 3 months (patient may be reconsidered for the trial after the procedure).
* Cor pulmonale.
* Heart transplant recipient.
* Significant renal disease defined as:

  * Renal artery stenosis;
  * Creatine clearance \<0.6 ml/second or serum creatinine≥ 200 mEq/L (≥2.26 mg/dl)
  * Overt nephropathy: ≥1 plus proteinuria on dipstick or urinary albumin excretion \> 200 micrograms/minute (300 mg/24 hrs)
  * Hyperkalemia; K\>5.5 mEq/L.
* Patient is simultaneously taking another experimental drug.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Number of patient reaching the 10mg/day dose level
timeFrame: 30 days after the treatment start
measure: Overall number of adverse events
timeFrame: at day 7 (visit 2), day 15 (visit 3), day 30 (visit 4), day 45 (visit 5) and day 60 (final visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Rezaul Farid Khan, Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00190710: A Trial of Carboplatin and Gemcitabine Versus Gemcitabine Alone in Patients With Non-Small-Cell Lung Cancer
Official title: A Randomized Phase III Trial of Paraplatin (Carboplatin) + Gemzar Versus Gemzar Alone in Patients With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2.


Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic new diagnosis of NSCLC, Stage IIIB with a cytologically positive pleural or pericardial effusion or Stage IV.
* No prior chemotherapy, including adjuvant or neoadjuvant therapy, for the treatment of NSCLC.
* ECOG Performance Status of 2 .
* Patients must be at least 3 weeks since major surgery. Patients must be at least 1 week since surgery, such as mediastinoscopy, pleuroscopy, or thoracostomy.
* Patients must have measurable disease, defined as lesions that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than 10 mm with spiral CT scan.

Exclusion Criteria:

* Any prior radiation therapy to the thoracic area.
* Active and ongoing systemic infection.
* Prior radiation to greater than 25% of the bone marrow.
* ECOG PS other than 2
* Patients with a known hypersensitivity to gemcitabine and carboplatin.

Primary outcomes:
measure: To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2.
Secondary outcomes:
measure: To determine and compare the 1-year survival produced by combined Paraplatin (carboplatin) + Gemcitabine versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2
measure: To determine the safety of combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2
measure: To compare the response rate between treatment groups
measure: To compare the changes in QOL between treatment groups
Other outcomes:
Locations:
city: Dallas
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00037310: New CVD Risk Factors for Lowered Cognitive Functioning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
Neurologic Manifestations
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2002-05-17
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To explore the associations between cognitive functioning and three major cardiovascular disease risk factors: high blood pressure; high total plasma homocysteine (tHcy); and ApoE e4 genotype.

Detailed description: BACKGROUND:

Arterial hypertension and high blood pressure (HBP) are major risk factors for cardiovascular disease (CVD) and stroke; they are also risk factors for lowered cognitive functioning. Except for diabetes, there have been comparatively few studies of other common risk factors, particularly with regard to interrelationships among risk factors which may adversely affect cognitive ability.

DESIGN NARRATIVE:

The study examines associations between cognitive functioning and three cardiovascular risk factors: 1) high blood pressure; 2) high total plasma homocysteine (tHcy), and 3) ApoE e4 genotype. These associations are examined cross-sectionally as well as longitudinally, using data collected at a follow-up visit of members of a cohort that has been followed for the past 18-19 years. Longitudinal data are used to examine both current and change in cognitive functioning. Some analyses are prospective (e.g., high blood pressure and change in cognitive functioning), while others are cross-sectional (e.g., ApoE e4 and current cognitive functioning) or retrospective (e.g., tHcy and change in cognitive functioning). Structural equation models are used to examine cross-sectional data in elucidating a general theoretical model. Two-stage growth curve analyses and survival analyses are appropriate methods for analyzing the longitudinal data. The study includes a very comprehensive set of measures that have already been collected or will be collected during the follow-up visit. All potential confounders of the association between the three target predictor variables and the various domains of cognitive functioning appear to have been included in this design.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Maine
name: Merrill Elias
References:
citation: Elias PK, Elias MF, Robbins MA, Budge MM. Blood pressure-related cognitive decline: does age make a difference? Hypertension. 2004 Nov;44(5):631-6. doi: 10.1161/01.HYP.0000145858.07252.99. Epub 2004 Oct 4.
Clinical trial NCT02290210: Phase 2 Study of URC102 to Assess the Efficacy and Safety in Gout Patients
Official title: A Placebo-controlled, Randomized, Double-blind, Multicenter Phase 2 Study to Assess the Efficacy and Safety of URC102 in Gout Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gout
Hyperuricemia
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2014-11-14
Enrollment: 64
Sex: MALE
Minimum age (years): 20
Maximum age (years): 70
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 assess safety, PK/PD and Urate Lowering Effect of URC102 in gout patients with hyperuricemia


Eligibility criteria: Inclusion Criteria:

* Diagnosed with gout

Exclusion Criteria:

* Participated in other clinical study within 12 weeks prior to enrollment, and received an investigational product (including placebo)

Primary outcomes:
measure: Trend of serum uric acid reduction and trend of serum uric acid levels
timeFrame: weekly for 3weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: JW Pharmaceutical
state: Seocho-dong
Study officials:
References:
Clinical trial NCT01380210: MRI Findings of Encephalopathy Associated With Carbon Dioxide (CO2) Intoxication
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CO2 Intoxication
Keywords: Carbon dioxide intoxication
Diffusion weighted images(DWI)
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University Hospital

Brief summary: Carbon dioxide intoxication is a rare condition and only few case reports are found in the literature. There were six patients who suffered from carbon dioxide intoxication in our hospital about two years ago. Two of them are more severe with conscious change and brain MRI studies of the two patients were performed. Reviewing the literature, no any report has mentioned about the encephalopathy associated with carbon dioxide intoxication. We want to review the brain lesions on the diffusion weighted images and the laboratory data of the patients for further diagnostic help.


Eligibility criteria: Inclusion Criteria:

* CO2 intoxication

Exclusion Criteria:

* None CO2 intoxication

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03096210: Titanium-Prepared Platelet Rich Fibrin in the Sinus Lifting Procedure
Official title: Comparison of the Clinic, Radiographic and Histological Effects of Allograft and T-PRF (Titanium-Prepared Platelet Rich Fibrin) Materials in the Sinus Lifting Procedure. Preliminary Results From a Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Sinus
Keywords: Maxillar sinus
Titanium-Prepared Platelet Rich Fibrin
Allograft
implant
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 18
Sex: ALL
Minimum age (years): 42
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the radiographic, histological and clinical comparisons of the completely autologous T-PRF or allograft effectiveness at the maxillary sinus elevation procedure.

Detailed description: Participants randomly divided into 2 groups and the test group had a Schneiderian membrane elevation with using balloon lifting technique and after that sinus was filled with T-PRF produced from the patients' blood and 4 months waiting period has been entered. At the end of the 4th month, the bone samples were received from the implant slots and sent to histological evaluation. After 3 months, implant stability was measured and recorded. In the control group, the same procedures were followed and sinus was filled with only allograft. Waiting period was changed to 6 months for this group.

Eligibility criteria: Inclusion Criteria:

* Participants having been diagnosed to display a residual crest height of less than 5mm in posterior maxilla and non-smokers were included.

Exclusion Criteria:

* Participants with blood platelet disorders, infectious and metabolic diseases, ongoing chemotherapy or radiotherapy, history of chronic sinusitis associated with maxillary sinuses, taking any antibiotics and/or anti-inflammatory drugs were excluded.

Primary outcomes:
measure: Histological Examination
timeFrame: At the first 4 and 6th months post surgery for the test and control groups, respectively.
Secondary outcomes:
measure: Radiological Examination
timeFrame: Within the first 4 and 6 months
measure: Implant stability measurements
timeFrame: Within the 3 months after implant surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01579110: Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.
Official title: Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Hemolysis
Hematologic Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Keywords: autoimmune hemolytic anemia
hemolytic anemia
Levamisole
Treatment of autoimmune hemolytic anemia
warm antibody dependant autoimmune hemolytic anemia
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2012-04-17
Enrollment: 100
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 whether Levamisole plus prednisone can further improve the efficacy，extend the remission duration and reduce the dosage of prednisone for newly diagnosed warm antibody autoimmune hemolytic anemia.

Detailed description: The first line treatment in warm antibody autoimmune hemolytic anemia (WAIHA) is the glucocorticoid, but most of the patients, hemolytic events will frequently recurred after end of treatment or during the gradual reduction in dosage of prednisolone. As a result, many patients will finally accepted long-term glucocorticoids or other immunosuppressive drugs. How to reduce the relapse rate of AIHA is still difficult. Levamisole（LMS）is a immunoregulator.Recent studies have shown LMS has been widely used to treat autoimmune diseases ,such as rheumatoid arthritis, systemic lupus erythematosus and idiopathic thrombocytopenic purpura. The purpose of this study is to determine whether LMS combined with prednisolone can further improve the efficacy，extend the remission duration and reduce the dosage of prednisone for newly diagnosed warm antibody autoimmune hemolytic anemia.

Eligibility criteria: Inclusion Criteria:

* Clinical and biochemical signs of hemolytic anaemia
* Positive Coombs test with anti-IgG or and with anti-CD3d
* Newly diagnosed Warm Autoimmune Hemolytic Anemia
* Adequate contraceptive measures for women of childbearing potential
* informed consent signed

Exclusion Criteria:

* Active infection which requires antibiotic treatment
* Pregnant or lactating women
* Epilepsy and mental illness
* Kidney and liver function abnormal

Primary outcomes:
measure: Number of patients in each group in complete or partial remission
timeFrame: one year
Secondary outcomes:
measure: Side effects
timeFrame: 1year
Other outcomes:
Locations:
city: TianJin
country: China
facility: Blood Diseases Hospital Chinese Academy of Medical Sciences
state: Tianjin
Study officials:
affiliation: Blood Diseases Hospital Chinese Academy of Medical Sciences
name: Yizhou Zheng, doctor
role: PRINCIPAL_INVESTIGATOR
References: