louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01538433: A Survey of Factors Affecting an Early or Delayed Diagnosis of IgA Nephropathy
Official title: A Survey of Factors Affecting an Early or Delayed Diagnosis of IgA Nephropathy: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IgA Nephropathy
Keywords: diagnosis
IgA nephropathy
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2012-02-24
Enrollment: 603
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The consecutive biopsy-proven IgAN patients in Guangdong General Hospital, Guangzhou,China

Brief summary: This is a survey of factors which affect a pathologically defined early or delayed diagnosis of IgA nephropathy in Guangdong General Hospital, Guangzhou, China. An early or delayed diagnosis of IgA nephropathy is pathologically defined using the recently published Oxford classification of IgA nephropathy. The factors to be surveyed include health examination including urine test, socioeconomic status of patients including education,etc.


Eligibility criteria: Inclusion Criteria:

* biopsy-proven IgA Nephropathy patients in Guangdong General Hospital, Guangzhou,China

Primary outcomes:
measure: Factors potentially affecting an early or delayed diagnosis of IgA Nephropathy
timeFrame: Before the biopsy
Secondary outcomes:
measure: Glomerular filtration rate(GFR) decline rate or reaching end-stage renal disease (ESRD) or doubling of serum creatinine
timeFrame: after the biopsy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nephrology Department,Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Wei Shi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06131333: Complex CAD Treated With PCI With DES Implantation.
Official title: Complex Coronary Artery Disease Treated With Percutaneous Coronary Intervention - COMPLEX Registry.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complex Coronary Artery Disease
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 980
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with symptomatic CAD, including chronic coronary syndromes (CCS) and acute coronary syndromes (ACS), qualified for PCI and meeting the criteria for complex CAD were included in the analysis.

Brief summary: COMPLEX Registry is an investigator-initiated, retrospective, high-volume Polish single-center clinical registry enrolling 980 consecutive patients with complex coronary artery lesions treated percutaneously between September 2015 and December 2021. All data were collected prospectively as regards the clinical and technical endpoints. The study aimed to assess the safety and efficacy of new-generation, thin-struts DES in patients with complex CAD at long-term clinical follow-up. The primary endpoint of the study was the occurrence of TLR during follow-up. Secondary endpoints were a procedural success and the occurrence of MACE, including all-cause death, MI, or TLR.


Eligibility criteria: Inclusion Criteria:

* For the inclusion of patients in this study, the complexity of CAD was defined as having at least one of the following characteristics: chronic total occlusion (CTO), lesion length \>40 mm, severe calcification assessed by angiography or intravascular imaging examination, multivessel PCI during the same intervention, or true bifurcation defined as any lesion involving both the main vessel (MV), proximal or distal and the ostium of the side branch (SB) (Medina 1,1,1; 1,0,1; or 0,1,1).

Exclusion Criteria:

* left main stem
* PCI treated during index procedure;
* cardiogenic shock,
* thrombolysis before PCI;
* 12-month follow-up not available

Primary outcomes:
measure: Target lesion revascularization (TLR)
timeFrame: 12 months
Secondary outcomes:
measure: Major adverse cardiac events (MACE)
timeFrame: 12 month
measure: Procedural success
timeFrame: Peri-procedural
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Poznan University of Medical Sciences, Poland
state: Wielkopolska
Study officials:
References:
Clinical trial NCT00069433: Enhancing the Outcome of Skills Training for People With Schizophrenia
Official title: Skills Training for Schizophrenia: Enhancing Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Psychotic Disorders
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-10-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine the effectiveness of skills training in people with schizophrenia and the applicability of the acquired skills in the "real world."

Detailed description: People with schizophrenia have a large number of social and symptom management training programs available to them. Studies suggest that these training programs are effective, but their generalizability and effectiveness in outpatient settings has not been thoroughly examined. This study will examine the treatment outcomes of a skills training approach in schizophrenic individuals taking antipsychotic medication.

Participants taking stable doses of risperidone, olanzapine, or quetiapine will be randomly assigned to receive either intensive symptom management and social skills training or group therapy for 12 months. A verbal memory test will be used to stratify the randomization procedure and to control for neurocognitive functioning.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder for \> 5 years
* Use of stable dose risperidone, olanzapine, or quetiapine for at least 1 month with no planned medication changes
* Social Behavior Scale (SBS) score \> 45
* Willing and able to provide informed consent

Exclusion Criteria:

* Intelligence Quotient \< 70
* Use of more than one antipsychotic medication
* Use of benzodiazepines, tricyclic antidepressants, or anticholinergic medication commonly used to treat extrapyramidal symptoms
* Diagnostic and Statistical Manual (DSM)-IV criteria for alcohol or other substance dependence
* History of any traumatic brain injury leading to loss of consciousness for \> 30 minutes
* Diagnosis of a comorbid medical condition that could interfere with antipsychotic medication treatment or the ability to complete the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: Hall-Brooke-The Center
state: Connecticut
city: Westport
country: United States
facility: Hall-Brooke Behavioral Health Services
state: Connecticut
Study officials:
References:
Clinical trial NCT04913233: Establishment and Clinical Validation of New Technologies for Accurate Screening of Colorectal Cancer Based on Multi-omics
Official title: Research on New Technologies for Screening and Early Diagnosis of Malignant Tumors - Establishment and Clinical Validation of New Technologies for Accurate Screening of Colorectal Cancer Based on Multi-omics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Keywords: Colorectal cancer
Cancer Screening
Colonoscopy
APCS
HRFQ
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 9000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals of 40-74 years old in non-high incidence of colorectal cancer areas(hospital outpatient population, community population in non-high-risk areas) .

Brief summary: Background:

The current screening techniques for colorectal cancer include colonoscopy, fecal occult blood, and high-risk factor questionnaires. However, the colorectal cancer screening technology that has been widely used at present cannot take into account sensitivity and specificity, and the tumor detection rate is low.

The purpose of research:

1. Build a new type of population colorectal cancer precision screening technology program;
2. Improve the detection rate of colorectal cancer in the population by new methods (compared with the existing domestic advanced technology) by ≥20%, and improve the specificity of colorectal cancer screening by ≥15% without significantly reducing the sensitivity.


Eligibility criteria: Inclusion Criteria:

Age: 40-74 years old

Exclusion Criteria:

1. Combine severe disorders to make it unsuitable for colonoscopy
2. Combine other tumors
3. Mental and behavioral abnormalities do not cooperate with the screener
4. Researchers believe that other reasons are not suitable for enrollment

Primary outcomes:
measure: Colorectal cancer detection rate in the population
timeFrame: through study completion, an average of 3 years
measure: Colorectal cancer screening specificity
timeFrame: through study completion, an average of 3 years
measure: Colorectal cancer screening sensitivity
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Haining
country: China
facility: Chinese Medicine Hospital of Haining City, Haining Cancer Preventional and Treatment Research Institute
state: Zhejiang
city: Jiashan
country: China
facility: Jiashan County Cancer Prevention and Treatment Institute
state: Zhejiang
city: Lanxi
country: China
facility: Lanxi City People's Hospital, Linjiang Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT03026933: Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled
Official title: A Multi-center, Randomized, Double Blind, Parallel Phase III Study to Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemias
Lead sponsor: Kuhnil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-01-20
Enrollment: 215
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To examine variation rate of Non-HDL with KI1107 comparison Rosuvastatin monotherapy.

Detailed description: Study design:

Randomly assigned to two groups(KI1107 or Rosuvastatin monotherpy) after 4 weeks run-in period and prescribed KI1107 or Rosuvastatin for 8 weeks.

Eligibility criteria: Inclusion criteria:

* Screening Visit

  * Age: 19-80
  * High risk for cardiovascular disease according to NCEP APT III
  * TG≥130mg/dL and 160mg/dL\>LDL-C≥100mg/dL for subjects who were not taking statins for 4 weeks
  * 500mg/dL\>TG≥200mg/dL and LDL-C\<110mg/dL for subjects who were taking statins for 4 weeks
* Baseline Visit

  * 500mg/dL\>TG≥200mg/dL
  * LDL-C\<110mg/dL
  * Reduction of LDL-C dompairng screening visit

Exclusion criteria:

* The patient has histories of acute artery disease within 3 months
* The patient has histories of operation revasculatiation or aneurysm within 6 months
* The patient has histories of Unexplained myaliga or diagnosed myalgia or rhabdomyolysis
* The patient has histories of Effectable disease to the procedrue and clinical trial result

Primary outcomes:
measure: Variation rate of Non HDL-C
timeFrame: 8 weeks
Secondary outcomes:
measure: Variation rate of TG
timeFrame: 4 weeks, 8 weeks
measure: Variation rate of Non HDL-C
timeFrame: 4 weeks
measure: Variation rate of TC
timeFrame: 4 weeks, 8 weeks
measure: Variation rate of LDL-C
timeFrame: 4 weeks, 8 weeks
measure: Variation rate of VLDL-C
timeFrame: 4 weeks, 8 weeks
measure: Variation rate of Apo A-I
timeFrame: 4 weeks, 8 weeks
measure: Variation rate of Apo B
timeFrame: 4 weeks, 8 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Kim CH, Han KA, Yu J, Lee SH, Jeon HK, Kim SH, Kim SY, Han KH, Won K, Kim DB, Lee KJ, Min K, Byun DW, Lim SW, Ahn CW, Kim S, Hong YJ, Sung J, Hur SH, Hong SJ, Lim HS, Park IB, Kim IJ, Lee H, Kim HS. Efficacy and Safety of Adding Omega-3 Fatty Acids in Statin-treated Patients with Residual Hypertriglyceridemia: ROMANTIC (Rosuvastatin-OMAcor iN residual hyperTrIglyCeridemia), a Randomized, Double-blind, and Placebo-controlled Trial. Clin Ther. 2018 Jan;40(1):83-94. doi: 10.1016/j.clinthera.2017.11.007. Epub 2017 Dec 7.
Clinical trial NCT04185233: Distraction and Nitrous Oxide for Venous Puncture
Official title: Comparison in Anxiety and Pain Scores Between Distraction and Nitrous Oxide for Procedural Pain in Children Aged 3 to 9 Years : a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Pain
Venous Puncture
Keywords: nitrous oxide
distraction
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 45
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: OTHER

Brief summary: This study will compare the efficiency of the iPad distraction or the administration of Nitrous Oxide on the anxiety decrease when a peripheral venous catheter is needed in children between 3 and 9 years old.

Detailed description: The study is aiming at demonstrating the efficacy of active distraction by an iPad on the anxiety consequent to venipuncture and insertion of a peripheral vein catheter. The comparator is nitrous oxide in a 50% mixture with oxygen that is routinely used for sedation during procedural pain. However, nitrous oxide has secondary effects particularly on the inhibition of Vitamin B12.

The primary outcome is anxiety scores. Secondary outcomes are pain scores and satisfaction of parents and health providers.

All children will have EMLA cream (mixture prilocaine and lidocaine) applied one hour prior to venous punction. Anxiety, pain and satisfaction scores will be recorded at baseline and then within an hour following the venipuncture and insertion of the peripheral vein catheter.

Eligibility criteria: Inclusion Criteria:

* Venous track needed
* French mother tongue
* Age between 3 and 9 years old

Exclusion Criteria:

* Children with cognitive disorder (autism, metabolic disorders,
* Children with cerebral-motor disability
* Children who don't speak french
* Children with ADHD treatment
* Children with epilepsy
* Children who present contraindication to the use of Nitrous oxide

Primary outcomes:
measure: Anxiety score
timeFrame: From one hour prior to venous puncture until 1 hour afterwards
Secondary outcomes:
measure: Pain score
timeFrame: From one hour prior to venous puncture until 1 hour afterwards
Other outcomes:
measure: Satisfaction score
timeFrame: From time of venous puncture until 1 hour afterwards
Locations:
city: Geneva
country: Switzerland
facility: Geneva Children's Hospital
Study officials:
affiliation: University of Geneva
name: Manon Cadoux, Student
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Geneva
name: Virginie Luscher, Student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00595933: Comparing Over-the-counter Dry Mouth Remedies After Radiation
Official title: A Comparative Trial of Over-the-counter Dry Mouth Remedies for Dry Mouth After Radiation to the Head and Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Xerostomia
Keywords: Head and Neck cancer
Radiation therapy
Dry mouth remedies
Dry Mouth
Xerostomia
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2008-01-16
Enrollment: 28
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of over-the-counter remedies for dry mouth.

Detailed description: Xerostomia (dry mouth) is the most common late complication of radiation therapy for head and neck cancers. When patients are cured or survive for several years, xerostomia often becomes quite bothersome; it affects their quality of life. This study compares the effectiveness of seven over-the-counter remedies, 2 rinses, 3 sprays and 2 chewing gums. A computer program will make random assignments so that the patient nor the physician will choose the order in which the products are tried. The remedies will be used for one week each and at the end of each period the patient will fill out a questionaire.

Eligibility criteria: Inclusion Criteria:

* Suffers from Xerostomia
* Surviver of head and neck cancer that received \>5000 cGy radiation therapy \>1 year prior to study entry.
* Able to chew, rinse and swallow.
* Ages 13-99 years of age

Exclusion Criteria:

* Currently using the following medications: anorexiants, antiacne agents, Anticholinergic agents, tricyclic antidepressants, chemotherapy agents.
* Unable to complete questionnaires

Primary outcomes:
measure: The effectiveness of seven over-the-counter remedies for dry mouth as determined by amount of saliva output and a brief questionaire.
timeFrame: 8-10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Greg Krempl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02020733: Evaluation of Pain During Hysterosalpingography With The Use Of Balloon Catheter Versus Metal Cannula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain During Hysterosalpingography
Keywords: Hysterosalpingography
balloon catheter
metal cannula
pain assessment
Lead sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Sponsor class: OTHER
First posted: 2013-12-25
Enrollment: 194
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to compare the metal cannula routinely used in our clinical practice with intrauterine hysterosalpingography catheter as a probable alternative device in a prospective, single-blinded, randomized study.


Eligibility criteria: Inclusion Criteria:

* Women aged between 18-47 years,
* applying for basic infertility evaluation to the Reproductive Endocrinology unit

Exclusion Criteria:

* The patients with a known hypersensitivity to iodine or radio-opaque contrast dye,
* vaginal bleeding,
* genital malignancy and
* any sign of pelvic inflammatory disease (PID) were excluded

Primary outcomes:
measure: the degree of pain experienced during the procedure
timeFrame: 1 hour after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Etlik Zubeyde Hanim Women's Health Teaching and Research Hospital
Study officials:
References:
Clinical trial NCT02744833: Study to Assess Safety, Tolerability, and Efficacy of GMI-1271 in Patients With Calf-level Deep Venous Thrombosis (DVT)
Official title: A Randomized Phase I/II Study to Assess the Safety, Tolerability, and Efficacy of GMI-1271 in Patients With Calf-Level Deep Venous Thrombosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Deep Venous Thrombosis
Keywords: DVT
Lead sponsor: GlycoMimetics Incorporated
Sponsor class: INDUSTRY
Collaborators: name: University of Michigan
First posted: 2016-04-20
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety profile of GMI-1271 and its effect on thrombus resolution in patients with distal calf vein Deep Venous Thrombosis (DVT).


Eligibility criteria: Inclusion Criteria:

* Age 18-75 years
* Male or female
* Diagnosed with acute isolated calf vein Deep Venous Thrombosis (DVT)
* Willing and able to participate in all required evaluations and procedures in this study protocol

Exclusion Criteria:

* History or presence of clinically significant medical condition or disease in the opinion of the principal investigator
* Uncontrolled acute life-threatening bacterial, viral or fungal infection
* Unable to be treated with systemic anticoagulants
* Current use of immunosuppressants, antiplatelets (other than aspirin), anticoagulants, and/or anti-epileptics
* Diagnosis of acute leukemia or multiple myeloma undergoing active treatment or maintenance treatment within the past 5 years
* Current or recent cancer treatment
* Major surgery within 21 days or planned surgery during the study period
* Female subjects who are pregnant or breastfeeding
* Known history of HIV, Hepatitis B or Hepatitis C
* Alcoholism or drug use
* Clinically significant cardiovascular disease

Primary outcomes:
measure: To evaluate the safety and tolerability of GMI-1271 in patients with calf-level DVT by assessment with vital signs, standard laboratory blood tests, electrocardiogram, and adverse event evaluation.
timeFrame: 19 days
Secondary outcomes:
measure: To evaluate the effects of GMI-1271 on thrombus resolution or stabilization as measured by Doppler ultrasound
timeFrame: 19 days
measure: To evaluate the effects of GMI-1271 on the incidence of bleeding time
timeFrame: 19 days
measure: To evaluate the effects of GMI-1271 on bleeding markers such as Prothrombin time (PT)
timeFrame: 19 days
measure: To evaluate the effects of GMI-1271 on biomarkers of coagulation
timeFrame: 19 days
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Suman Sood, MD
role: PRINCIPAL_INVESTIGATOR
References: