louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01614548: Management of Prostate Cancer in Central China
Official title: Comparisons of Management and Outcome of Prostate Cancer in Central China Between 2003 and 2008: A Multi-institutional Report
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostatic Neoplasms
Prostate Cancer
Disease Management
Rural
Urban
Lead sponsor: Zhengzhou University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Zhengzhou University
name: the cancer hospital of Zhengzhou University
name: Third Affiliated Hospital of Zhengzhou University
name: People's Hospital of Zhengzhou University
name: Xinyang Central Hospital
name: Zhoukou Central Hospital
name: Center hospital of Nanyang
name: Center hospital of Shangqiu
name: Zhumadian Central Hospital
name: Anyang Regional Hospital
name: Luoyang Central Hospital
name: First People's Hospital of Kaifeng
First posted: 2012-06-08
Enrollment: 789
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all inpatients with prostate cancer in 14 hospitals

Brief summary: Some recent reports indicate that incidence of prostate cancer is increasing rapidly in China. However, no large-scale survey of prostate cancer has been done in central China, few data are available regarding its management. The investigators aimed to analyze the management of prostate cancer and compare the outcome of patients with such a survey.

The investigators collected data of patients diagnosed with prostate cancer from the 2003 and 2008 in central China. Data were disaggregated by rural and urban hukou. The survival rate of patients was analyzed using Kaplan-Meier method. Prognostic factors were analyzed using the log-rank test and Cox proportional hazards model.


Eligibility criteria: Inclusion Criteria:

* patients with newly diagnosed prostate cancer were included in the study. Exclusion Criteria:
* Those with a history of prostate cancer who were treated for another disease were excluded from study.

Primary outcomes:
measure: overall survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: the first affiliated hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Liu Bingqian, Ph.D MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00217048: Effect of Yohimbine on Colon Transit
Official title: Effect of Oral Yohimbine on Colonic Transit: Randomized, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy Volunteers
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done to learn if yohimbine, a naturally occurring drug, affects the speed at which food travels through the stomach, intestines and colon, and if yohimbine affects the amount of liquid you can drink in a short period of time. Understanding how yohimbine works on the gut may help develop new treatments for patients with constipation. Yohimbine has been approved by the Food and Drug Administration (FDA) for routine clinical use, however, its use as proposed in this study is considered investigational.


Eligibility criteria: * Healthy male or non-pregnant, non-breastfeeding female volunteers, -18-65 years old;
* Able to provide written informed consent before participating in the study;
* Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Primary outcomes:
measure: Colonic transit
Secondary outcomes:
measure: Small bowel transit time
measure: Gastric emptying time
measure: Maximum tolerated volume ingested during satiation testing
measure: Average stools per day
measure: Stool consistency
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Adil E Bharucha, MBBS, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02494648: Effects of Inspiratory Muscles Strengthening Among Coronary Patients on the Sleep Apnea Obstructive Syndrome
Official title: Effects of Inspiratory Muscles Strengthening Among Coronary Patients on the Sleep Apnea Obstructive Syndrome (SAOS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Acute Coronary Syndrome
Keywords: Obstructive sleep apnea
Resistive inspiratory muscle training
Coronary artery disease
Cardiac rehabilitation
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-07-10
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obstructive sleep apnea (OSA) syndrome affects up to 5% of the general population. The prevalence is multiplied by 13 in coronary artery disease (CAD) patients. Many studies have shown that OSA syndrome was the main risk factor for cardiovascular morbidity and mortality (RR = 9.1 \[95%, 2.6 to 31.2\]).

If the value of treatment with Continuous Positive Airway Pressure (CPAP) in symptomatic CAD patients (daytime sleepiness and/or 2 clinical symptoms with Apnea Hypopnea Index (AHI) ≥ 20) appears to be established, treatment with CPAP in asymptomatic CAD patients (with AHI\> 30) may be too demanding. Alternative treatments are rare and results are highly variable. Therefore, it would be interesting to suggest other treatment modalities with moderate coronary and/or minimally symptomatic OSA syndrome.

Detailed description: This study aims to assess the relevance of inspiratory muscles strengthening on reducing AHI in CAD patients with moderate OSA (AHI between 15 and 30).

Eligibility criteria: Inclusion Criteria:

* Patients with moderate OSA (15 \<AHI \<30)
* Period between acute coronary syndrome and inclusion \<60 days
* Patients included in cardiac rehabilitation

Exclusion Criteria:

* Obstructive lung disease with Tiffeneau index less than 70%.
* Restrictive lung disease with a reduction of total lung capacity (TLC)
* Treatment for OSA or clinical context (comorbidity) justifying CPAP
* Congestive heart failure, thoracic surgery by sternotomy
* Spontaneous pneumothorax
* Severe Asthma
* Ruptured eardrum, or another disease of the middle ear, or acute sinusitis

Primary outcomes:
measure: AHI Variation
timeFrame: At 6 weeks
Secondary outcomes:
measure: Circumference of the neck in centimetre
timeFrame: At 6 weeks
measure: Epworth questionnaire to evaluate the deficit of sleep
timeFrame: at 6 weeks
measure: Pittsburgh questionnaire to evaluate the quality of sleep
timeFrame: At 6 weeks
measure: SF12 questionnaire to evaluate the quality of life
timeFrame: At 6 weeks
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: David HUPIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03769948: Clinical Decision Support Algorithm to Predict Diabetic Retinopathy
Official title: Validating a Clinical Decision Support Algorithm Developed With Demographic, Co-morbidity, and Lab Data to Diagnose, Stage, Prevent, and Monitor a Patient's Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Retinopathy
Lead sponsor: Oklahoma State University Center for Health Sciences
Sponsor class: OTHER
Collaborators: name: Oklahoma State University
name: University of Oklahoma
First posted: 2018-12-10
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The cohort will be selected from diabetic patients that have Electronic Medical Records in Harold Hamm Diabetes Center.

Brief summary: Diabetic retinopathy (DR), a complication of diabetes, is a leading cause of blindness among working-aged adults globally. In its early stages, DR is symptomless, and can only be detected by an annual eye exam. Once the disease has progressed to the point where vision loss has occurred, the damage is irreversible. Consequently, early detection is quintessential in treating DR. Two barriers to early detection are poor patient compliance with the annual exam and lack of access to specialists in rural areas. This research is focused on developing and validating new, cost-effective predictive technologies that can improve early screening of DR. Our overall objective is to develop and implement an entire suite of tools to detect diabetes complications in order to augment care for underserved rural populations in the US and internationally.


Eligibility criteria: Inclusion Criteria:

For diabetic patients with DR:

* With 250.xx diabetes and 362.0x DR ICD-9 codes
* All variables are complete within the observation window

For diabetic patients without DR:

* With 250.xx diabetes ICD-9 codes
* Without 362.0x DR ICD-9 codes
* All variables are complete within the observation window

Primary outcomes:
measure: Diabetic retinopathy indicator (yes/no)
timeFrame: March, 2019
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01907048: Patient and Physician Knowledge of Key Safety Messages
Official title: Xarelto (Rivaroxaban) Risk Minimisation Plan Evaluation: Patient and Physician Knowledge of Key Safety Messages
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulation
Keywords: Survey
Effectiveness of risk minimization measures
Rivaroxaban
Anticoagulants
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
name: RTI Health Solutions
First posted: 2013-07-24
Enrollment: 2227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physicians of various specialties; patients treated in primary care and specilized clinical practices.

Brief summary: This cross-sectional epidemiologic study measured physician and patient awareness and understanding of the key messages in the Xarelto prescriber guide and Xarelto patient alert card.


Eligibility criteria: - Inclusion criteria:

Physician eligibility:

* Prescription of rivaroxaban in the past 6 months for adult patients for the Prevention of stroke and systemic embolism with non-valvular atrial fibrillation (SPAF) or Treatment of deep venous thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT.

Patient eligibility:

* Use of rivaroxaban for SPAF or DVT within the previous 3 months; aged 18 years and above; able to understand and complete the consent form and patient questionnaire.

Primary outcomes:
measure: Knowledge and understanding among physicians regarding key safety information contained in the prescriber guide assessed by web-based questionnaire
timeFrame: Up to 18 months
measure: Knowledge and understanding of patients regarding the key safety information contained in the patient alert card assessed by paper-based questionnaire
timeFrame: Up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: France
city: Multiple Locations
country: Germany
city: Multiple Locations
country: Spain
city: Multiple Locations
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01887548: Personality Traits and Its Impact on Quality of Life and Clinical Outcome Evaluation in Crohn's Patients
Official title: Personality Traits and Its Impact on Quality of Life and Clinical Outcome Evaluation in Patients With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn's Disease
Keywords: Crohn's disease
inflammatory bowel disease
quality of life
personality
neuroticism
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2013-06-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Quality of life is recommended as one of essential parameters to evaluate treatment effect and clinical outcome in patients with Crohn's disease (CD). Recent studies reported that several disease-unrelated variables may affect quality of life in CD patients. This study is dedicated to investigate the influence of various personality traits on quality of life, and whether or not they should be taken into account when evaluating clinical outcomes in patients with CD.

Detailed description: This is a prospective, single-center study.

All enrolled patients are divided into 2 groups:

* Group 1: quiescent CD group (CDAI≤150 points)
* Group 2: active CD group (CDAI\>150 points)

All enrolled patients are required to accomplish the following questionnaires at visit:

* Inflammatory Bowel Disease Questionnaire (IBDQ)
* Neuroticism (N) and Lie (L) subscale of the Eysenck Personality Inventory (EPI)
* Hospital Anxiety and Depression Scale (HADS)
* Buss-Perry Aggression (BPA) questionnaire

All questionnaires are translated and validated in Chinese population.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* a definite diagnosis of CD

Exclusion Criteria:

* current or previous mental disorders
* receiving or once received psychotherapy
* presence of major medical conditions (such as necessity of an operation)
* chronic disease history other than inflammatory bowel disease
* unwilling to participate in or cannot accomplish current study

Primary outcomes:
measure: IBDQ
timeFrame: one week
Secondary outcomes:
measure: Eysenck Personality Inventory (EPI)
timeFrame: one week
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: one week
measure: Buss Perry Aggregation (BPA) questionnaire
timeFrame: one week
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Surgery, Jinling Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT00692848: Impact of Procalcitonin on the Management of Children Aged 1 to 36 Month Presenting With a Fever Without a Source
Official title: The Impact of Procalcitonin on the Management of Children Aged 1 to 36 Month Presenting With a Fever Without a Source
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procalcitonin
Fever Without Source
Bacterial Infection
Bacteremia
Keywords: Procalcitonin
Antibiotic
Fever without source
Fever without focus
bacteremia
Urinary tract infection
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2008-06-06
Enrollment: 384
Sex: ALL
Minimum age (years): 1
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Serious bacterial infections are often difficult to detect in children with fever without source. Procalcitonin is a better blood marker of infection than White blood cell count and possibly than C-reactive protein. This could lead to a reduction in antibiotic prescription. Our objective is to evaluate the impact of Procalcitonin result on antibiotic prescription in children 1 to 36 month old with fever without source and our hypothesis is that it will lower the antibiotic prescription rate


Eligibility criteria: Inclusion Criteria:

* Children 1-36 months
* With rectal temperature \>38.0 C
* And no identified source of infection after history and physical examination

Exclusion Criteria:

* acquired or congenital immunodeficiency

Primary outcomes:
measure: Difference in prescription of antibiotics between the two groups, excluding those treated for a bacterial infection identified by the ED investigations
Secondary outcomes:
measure: Difference in hospitalization rate between the two groups (excluding those hospitalized for an identified infection)
measure: Procalcitonin sensitivity and specificity
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Sainte-Justine Emergency Department
state: Quebec
Study officials:
affiliation: St. Justine's Hospital
name: Sergio Manzano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02407548: The Effects of Dietary Supplement of Coenzyme Q10（CoQ10） on Dyslipidemia
Official title: The Effects of Dietary Supplement of Coenzyme Q10 on Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemia
Keywords: cholesterol efflux
dyslipidemia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In previous study the investigators found that CoQ10 can improve cholesterol efflux from macrophages in cell model, ApoE mice model and small-scale of healthy volunteers. In addition, CoQ10 has strong antioxidant activity and is an essential factor of mitochondria electron transport chain. So the investigators hypothesize that CoQ10 may have some health promotion effect on dyslipidemia, risk factor of atherosclerosis and other cardiovascular diseases. On this purpose, the investigators are going to recruit 150 dyslipidemia patients to supply CoQ10+vitamin E or CoQ10 alone or placebo in different doses for 24 weeks to explore the effects of CoQ10 on cholesterol efflux and lipid profiles on dyslipidemia.


Eligibility criteria: Inclusion Criteria:

* The subjects were considered to have dyslipidemia if they met 2 of the following 4 criteria:

  * fasting total cholesterol concentration\>200 mg/dL,
  * fasting triglyceride concentration\>150mg/dL,
  * fasting LDL-cholesterol concentrations\>100 mg/dL, or
  * fasting HDL-cholesterol concentrations\>40 mg/dL.

Exclusion Criteria:

* history of CVD or other severe chronic disease or use of any drugs known to affect lipid metabolism.
* use any antioxidant such as Vitamin E, vitamin C,Phytochemicals and coenzyme Q10 within two months before trial.
* pregnant or lactating women

Primary outcomes:
measure: Effects of CoQ10 on lipid profile
timeFrame: 6 months
Secondary outcomes:
measure: Effects of CoQ10 on blood glucose and insulin
timeFrame: 6 mouth
measure: Effects of CoQ10 on oxidative stress and inflammation
timeFrame: 6 mouth
Other outcomes:
measure: Effects of CoQ10 on FGF21
timeFrame: 6 month
measure: Effects of CoQ10 on cholesterol efflux from macrophages
timeFrame: 6 month
Locations:
city: Guangzhou
country: China
facility: Hongshan Street community health service centre
state: Guangdong
Study officials:
affiliation: SUN YAY-SEN UNIVERSITY
name: ling wenhua, professor
role: STUDY_DIRECTOR
References:
citation: Zhang P, Chen K, He T, Guo H, Chen X. Coenzyme Q10 supplementation improves adipokine profile in dyslipidemic individuals: a randomized controlled trial. Nutr Metab (Lond). 2022 Mar 3;19(1):13. doi: 10.1186/s12986-022-00649-5.
citation: Zhang P, Yang C, Guo H, Wang J, Lin S, Li H, Yang Y, Ling W. Treatment of coenzyme Q10 for 24 weeks improves lipid and glycemic profile in dyslipidemic individuals. J Clin Lipidol. 2018 Mar-Apr;12(2):417-427.e5. doi: 10.1016/j.jacl.2017.12.006. Epub 2017 Dec 21.
Clinical trial NCT00165048: Selective COX-II Inhibitor as a Palliative Therapy in Patients With R1 or R2 Resection for Disseminated Stomach Cancer - A Multi-Centre Prospective Randomized Controlled Trial
Official title: Selective COX-II Inhibitor as a Palliative Therapy in Patients With R1 or R2 Resection for Disseminated Stomach Cancer - A Multi-Centre Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cancer of Stomach
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 investigate the effect of selective COX-II inhibitor in patients with regionally disseminated stomach cancer treated by palliative resection (so called R1 or R2 gastrectomy).

Detailed description: Cyclo-oxygenase (COX) is a family of enzymes regulating the conversion of arachidonic acid to prostaglandins. COX-II is an inducible enzyme, which expresses excessively when there are stimuli such as inflammation or hypergastrinaemia. Up to 40% of patients with stomach cancer are found to have disseminated disease during surgical exploration. While palliative resection could offer a marginal benefit in the survival of these patients, almost all patients will die of progression of disease within a short time span. Palliative chemotherapy has been used in the past. However, there is no evidence that the chemotherapy can confer any survival advantages, and the side-effects and toxicity of the treatment may indeed compromise the quality of life of these patients. With a better understanding of the relation between COX-II and stomach cancer, it may be possible to suppress the progression of the residual cancer cells after the palliative resection by giving the patients selective COX-II inhibitors.

Eligibility criteria: Inclusion Criteria:

* Stomach cancer with peritoneal or lymphatic spread beyond the scope of curative resection
* Palliative resection can be performed
* Normal RFT

Exclusion Criteria:

* Solid organ metastases
* Poor performance status
* On long-term aspirin or NSAID
* Renal or hepatic dysfunction
* Bleeding disorder
* Hypersensitive to COX-II inhibitors/aspirin/NSAID
* No history of myocardial infarct or stroke

Primary outcomes:
measure: Symptom-free susrvival and the quality of life score within the two years of study period.
Secondary outcomes:
measure: Overall survival in long-term.
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Combined Gastro-intestinal Cancer Clinic
Study officials:
affiliation: Chinese University of Hong Kong
name: Enders K.W. Ng, MD
role: PRINCIPAL_INVESTIGATOR
References: