louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01295658: Cancer Survivor Registry: The Breast Cancer M.A.P. (Mind Affects the Physical) Project
Official title: Cancer Survivor Registry: The Breast Cancer M.A.P. (Mind Affects the Physical) Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancers
Keywords: cancer
cancer survivorship
psychosocial needs
cancer experience
metastatic breast cancer
breast cancer
caregiver
Lead sponsor: Cancer Support Community, Research and Training Institute, Philadelphia
Sponsor class: OTHER
First posted: 2011-02-14
Enrollment: 3729
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any individual who has received a cancer diagnosis.

Brief summary: Cancer Survivor Registry: The Breast Cancer M.A. P. (Mind Affects the Physical M.A.P.) Project to identify and help us understand the emotional and social needs of breast cancer survivors.

Detailed description: The Cancer Survivor Registry: The Breast Cancer M.A.P. (Mind Affects the Physical) Project was the first registry of its kind to look at the emotional and social needs of individuals diagnosed with breast cancer and track how their needs changed throughout their cancer journey. Data will raise awareness and help develop programs to address the needs of breast cancer survivors. Findings from the Registry are disseminated online at www.CancerSupportCommunity.org/RegistryIndexReport2017

Eligibility criteria: Inclusion Criteria:

* Having received a cancer diagnosis

Exclusion Criteria:

* None

Primary outcomes:
measure: Self-reported quality of life measures
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Cancer Support Community Research & Training Institute
state: Pennsylvania
Study officials:
affiliation: Cancer Support Community
name: Linda House, RN, BSN, MSM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00578058: Randomized Trial Of Tinnitus Retraining Therapy
Official title: Randomized Trial Of Tinnitus Retraining Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tinnitus
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2007-12-20
Enrollment: 180
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: Millions of Americans suffer from tinnitus. However, there is no widely accepted treatment that has been shown to be effective in controlled investigations. The purpose of this study is to evaluate the effectiveness of Tinnitus Retraining Therapy (TRT). This study will investigate the contributions of counseling, the use of hearing aids and sound generators, and the importance of setting masking noise to a particular level. All groups will receive the same Counseling. In pilot studies we have developed a picture-based counseling protocol. The results of this study will determine if TRT is more effective than masking or counseling alone.


Eligibility criteria: Inclusion Criteria:

* Have experienced tinnitus for at least 4 months.
* Have the ability to participate in research.

Exclusion Criteria:

* Have a treatable otological disorder.
* Are involved in litigation.
* Have or are suspected of having a serious psychiatric problem.

Primary outcomes:
measure: Iowa Tinnitus Handicap Questionnaire
timeFrame: 18 months
Secondary outcomes:
measure: Tinnitus measures
timeFrame: 18 months
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Buffalo
country: United States
facility: University at Buffalo, State University of New York
state: New York
city: Johnson City
country: United States
facility: East Tennessee State University
state: Tennessee
Study officials:
affiliation: University of Iowa
name: Richard S Tyler, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004558: Antiarrhythmic Effects of N-3 Fatty Acids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arrhythmia
Heart Diseases
Tachycardia, Ventricular
Ventricular Fibrillation
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-02-10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: To determine the antiarrhythmic effects of dietary N-3 fatty acids in patients with implanted defibrillators.

Detailed description: BACKGROUND:

Ventricular tachycardia (VT) and ventricular fibrillation (VF) are common causes of the 300,000 sudden deaths occurring in the United States each year. Most of these victims have associated heart disease, most commonly coronary artery disease. Populations consuming considerable quantities of fish and marine mammals have lower than expected mortality rates from coronary disease. Interventional and observational trials have indicated that fatty fish consumption decreases the death rate from coronary artery disease, in part by reducing the number of sudden deaths. Animal and tissue culture studies both support the hypothesis that these beneficial effects are from the antiarrhythmic properties of n-3 long chained polyunsaturated fatty acids (eicosapentaenoic and docosahexaenoic acids).

DESIGN NARRATIVE:

Prospective, randomized, double blinded trial. Survivors of VT and VF with an implantable defibrillator were randomized, 100 to dietary supplementation with n-3 polyunsaturated fatty acids(PUFA) or 100 to a placebo. Adherence to the supplement were assessed by measurements of plasma, red cell, and adipose tissue n-3 fatty acid concentrations. The primary outcome variable was the incidence of recurrent VT or VF, but secondary variables were also assessed using serial implantable cardioverter defibrillator (ICD) assessment, correlation of the rhythms with the biochemical measurements of n-3 fatty acids, hospitalization rates and quality of life. The (ICD) was the best protection available to patients and stored rhythm electrograms which allowed documentation of rhythm endpoints.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Raitt MH, Connor WE, Morris C, Kron J, Halperin B, Chugh SS, McClelland J, Cook J, MacMurdy K, Swenson R, Connor SL, Gerhard G, Kraemer DF, Oseran D, Marchant C, Calhoun D, Shnider R, McAnulty J. Fish oil supplementation and risk of ventricular tachycardia and ventricular fibrillation in patients with implantable defibrillators: a randomized controlled trial. JAMA. 2005 Jun 15;293(23):2884-91. doi: 10.1001/jama.293.23.2884.
Clinical trial NCT04665258: Male Reproduction COVID Sequelae Study (MARCOS).
Official title: Corona Virus Disease 19 (COVID-19) Vaccine and Impact on Fertility Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Infertility, Male
Keywords: COVID-19 Vaccine
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Young men of reproductive age scheduled for COVID-19 Vaccine

Brief summary: The purpose of this study is to investigate the effects of COVID-19 Vaccination on semen parameters and to determine how long these possible changes may last following vaccination.


Eligibility criteria: Inclusion Criteria:

1. Receiving COVID-19 vaccines
2. Male age 18-50 years old

Exclusion Criteria:

1. Adults unable to consent
2. Women
3. Prisoners
4. Men who have been receiving Testosterone replacement therapy or anabolic steroids within the last year
5. Men with a history of Azoospermia
6. Men with a genetic or other medical condition known to be associated with decreased semen parameters (i.e. Klinefelter's syndrome, Y-Chromosome Microdeletion (YCMD), post-chemotherapy treatment, etc.)
7. Positive COVID-19 test within the last 3 weeks

Primary outcomes:
measure: Sperm concentration
timeFrame: up to 6 months
measure: Sperm motility
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Miami
name: Ranjith Ramasamy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04370158: Interstitial Lung Diseases Cohort Study in China
Official title: Interstitial Lung Diseases Cohort Study in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Interstitial Lung Diseases
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Guangzhou Medical University
name: Xiangya Hospital of Central South University
name: First Hospital of China Medical University
name: The Fourth Affiliated Hospital of China Medical University
name: Peking Union Medical College Hospital
First posted: 2020-04-30
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the hospitals involved in this study

Brief summary: In this project, the clinical diagnosis of interstitial lung diseases was carried out for the population with suspected interstitial lung diseases selected from the community cohort, and the confirmed patients were included into the existing clinical cohort of interstitial lung diseases, forming an interstitial lung diseases special disease cohort consisting of 3,000 patients and corresponding matched control groups. According to characteristics of interstitial lung disease and the needs of National Key R\&D Program of China, this study will formulate unified clinical follow-up strategy to do long-term standardized clinical follow-up in patients with interstitial lung disease. The detailed information for clinical diagnosis and treatment as well as biological samples were collected to identify disease phenotype and build the database and biological sample library for interstitial lung disease cohort study. This study aims to provide evidence for molecular classification, screening and validation of biomarkers as well as precise diagnosis and prevention in patients with interstitial lung disease.


Eligibility criteria: Inclusion Criteria:

* Physician diagnosed IPF during the last 3 months based upon ATS/ERS/JRS/ALAT guidelines 2011
* Agree to sign the informed consent

Exclusion Criteria:

* Lung transplantation expected within the next 6 months

Primary outcomes:
measure: Database and biological sample library for Chinese patients with interstitial lung disease
timeFrame: up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Huaping Dai
state: Beijing
Study officials:
References:
Clinical trial NCT04930458: Remineralization of Dentine Caries Using Two Remineralizing Agents Which Are Nanosilver Fluoride and Casein phosphopeptides_amorphous Calcium Phosphate
Official title: Remineralization of Dentine Caries Using Nanosilver Fluoride and Casein Phosphopeptides-amorphous Calcium Phosphate (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Keywords: Dental caries remineralization
Nanosilver fluoride
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 135
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is randomized controlled trial ...The null hypothesis suggests that there is no significant difference between nanosilver fluoride and sodium fluoride with Casein phosphopeptides_amorphous calcium phosphate in the remineralization of dental caries.

Detailed description: the patients will be randomly assigned to one of three study groups the first group is nanosilver fluoride,the second is casein phosphopeptides_amorphous calcium phosphate and the third is sodium fluoride as positive control..the three material will be applied in single application with no repetition ..follow up after one and three month ..the patient should have at least one carious lesion(ICDASII code 5)

Eligibility criteria: * Clinical diagnosis of carious lesion
* participants should be free of any systemic diseases.

Exclusion Criteria:

* sensitivity to Silver or other heavy-metal ions or any milk-related allergies and medical conditions involving the kidneys.
* The tooth was excluded if it had pulp exposure, abscess/fistula, sensitivity to percussion

Primary outcomes:
measure: The incidence of patient with arrested dental caries using international caries detection and assessment system II(ICDAS II)
timeFrame: Change in the state of dental caries after one and 3 months after topical application of nanosilver fluoride and sodium fluoride with casein phosphopeptides amorphous calcium phosphate
Secondary outcomes:
Other outcomes:
Locations:
city: Karbala
country: Iraq
facility: Alhur alriyahi specialized dental center
Study officials:
affiliation: University of Baghdad
name: Duaa Jawad
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03508258: Study to Describe Risk of Bleeding in Patients Depending on the Different Anticoagulant Therapy They Are on for Atrial Fibrillation (AF)
Official title: Investigating the Association of Type of Anticoagulation Treatment for Non-valvular Atrial Fibrillation and Risk of Bleeding in England
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Non-valvular Atrial Fibrillation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-04-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: NVAF patients newly prescribed NOACs in England

Brief summary: Study of patients with nonvalvular atrial fibrillation (NVAF) who are newly prescribed NOACs (Novel Oral Anticoagulants) in routine clinical practice in England


Eligibility criteria: Inclusion Criteria:

* Diagnosis of atrial fibrillation at or prior to index (the initiation of treatment)
* Incident prescription of an oral anticoagulant (index date)
* Patients with at least one year of computerized data prior to index date

Exclusion Criteria:

* Patients identified with a diagnosis of mechanical heart valve replacement or mitral stenosis identified at any point in the pre-index period in either CPRD by Read codes or in HES as ICD-10/OPCS codes
* Patients with indication of venous thromboembolism (pulmonary embolism or deep vein thrombosis) identified in in either CPRD by Read codes or HES by ICD-10/OPCS codes within 3 months prior to index

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Incidence of major bleeding
timeFrame: At the end of 1 year
measure: Incidence of intracranial bleeding
timeFrame: At the end of 1 year
measure: Incidence of gastrointestinal bleeding
timeFrame: At the end of 1 year
measure: Incidence of clinically relevant non-major bleeding
timeFrame: At the end of 1 year
measure: Incidence of ischemic stroke
timeFrame: At the end of 1 year
measure: Incidence of unspecified stroke
timeFrame: At the end of 1 year
measure: Incidence of systemic embolic events
timeFrame: At the end of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Local Institution
state: Maryland
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00702858: Trial of Blue Citrus Compared to Placebo in Patients Receiving Aromatase Inhibitor Therapy for Estrogen Receptor Positive Post-Menopausal Breast Cancer
Official title: Pilot, Single Center Randomized Controlled, Double-Blind, Cross Over, Intent to Treat Trial of Blue Citrus to Placebo in Those Breast Cancer Patients Receiving Aromatase Inhibitor Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Joint Pain
Keywords: Breast Cancer
Joint Pain
Aromatase Inhibitors
Lead sponsor: Legacy Health System
Sponsor class: OTHER
First posted: 2008-06-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This purpose of this study is to determine if the herbal compound, Blue Citrus, decreases joint and bone pain associated with Aromotase Inhibitor therapy (AIT).

Another purpose of the study is to find out if Blue Citrus improves how you feel while taking AIT and if your quality of life improves.

Detailed description: Post-menopausal women currently on AIT for breast cancer treatment who self-report musculoskeletal side effects related to AIT to their physicians.

Eligibility criteria: Inclusion Criteria:

1. Post Menopausal - evidenced by no menses for the past 6 months or FSH level \>40
2. Patient complaints of musculoskeletal symptoms
3. Currently taking AIT for ER positive postmenopausal breast cancer

Exclusion Criteria:

1. Previously taken Blue Citrus
2. Presence of bone metastasis
3. Unable to complete VAS Pain Scale
4. Unable to comply/complete SF 12 Quality of Life survey
5. Plan to discontinue AIT in less then six months
6. Unable to complete ADL scale
7. Have diagnosis of fibromyalgia
8. Have diagnosis of rheumatoid arthritis

Primary outcomes:
measure: Determine if Blue Citrus decreases musculoskeletal symptoms while on AIT as compared to Placebo
timeFrame: 6 months
Secondary outcomes:
measure: Determine if Blue Citrus use leads to reduction in use of other pain medications compared to placebo
timeFrame: 6 months
measure: Determine if Blue Citrus compared to placebo improves Quality of Life,improves the ability to perform Activities of Daily Living
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Legacy Health System
name: Nathalie Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06166758: Feasibility Study: Educational Genetic Test Video
Official title: Pilot Feasibility Study: Educational Genetic Test Video
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Education
Keywords: Genetic testing education
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Assess whether introducing an educational video regarding the benefits, risks, and limitations of genetic testing affects prostate cancer patients' decisional conflict regarding receiving germline genetic testing.


Eligibility criteria: Inclusion Criteria:

* Prostate cancer patients who have been prescribed germline genetic testing by their provider
* Understand written and spoken English
* Have not received germline genetic testing for hereditary cancer risk in the past

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant individuals
* Prisoners

Primary outcomes:
measure: Assess the value of presenting patients an educational video regarding the benefits risks, and limitations of genetic testing for hereditary cancer risk.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Elizabeth Monast
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06156358: Indicators of Anastomotic Leak After Colorectal Surgery
Official title: Blood Indices as Predictors of Anastomotic Leak After Colorectal Surgery - Is It Useful? A Retrospective Analysis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 441
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients underwent abdominal surgery with colon or rectum anastomosis

Brief summary: We reviewed the patient underwent colorectal surgery with anastomosis and identified patients with anastomotic leak. Then we started to figure out what blood investigation could be related to anastomotic leak.


Eligibility criteria: Inclusion Criteria:

* Patient underwent colorectal surgery with anastomosis

Exclusion Criteria:

* Patient has no colon or rectum as part of anastomosis
* Patient with more than one procedure within 6 month

Primary outcomes:
measure: Accuracy of blood investigations in detecting anastomotic leak
timeFrame: JAN 2015 - DEC 2022
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00594958: Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51
Official title: Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Japanese Encephalitis
Lead sponsor: Valneva Austria GmbH
Sponsor class: INDUSTRY
First posted: 2008-01-16
Enrollment: 639
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean Titers for anti-JEV neutralizing antibody.

Detailed description: This is a randomized, controlled, multi-center, double blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years.

624 subjects will be enrolled at approximately 6 sites in study centers in Austria and Germany.

Eligibility criteria: Main Inclusion Criteria:

* Male and female subjects aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test

Main Exclusion Criteria:

* History of immunodeficiency or immunosuppressive therapy, known HIV, drug addiction including alcohol dependence

Primary outcomes:
measure: GMT for Anti-JEV Neutralizing Antibody
timeFrame: day 56
Secondary outcomes:
measure: Safety
timeFrame: study duration
measure: SCR for Anti-JEC Neutralizing Antibody Titer
timeFrame: day 56
Other outcomes:
Locations:
Study officials:
affiliation: Valneva Austria GmbH
name: Susanne Eder, Mag.
role: STUDY_DIRECTOR
References: