louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00219271: Effect Of Zoledronic Acid On Circulating And Bone Marrow-Residing Prostate Cancer Cells In Patients With Clinically Localized Prostate Cancer
Official title: Effect Of Zoledronic Acid On Circulating And Bone Marrow-Residing Prostate Cancer Cells In Patients With Clinically Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: Prostate cancer
molecular staging
antitumor potential
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: University of Athens
First posted: 2005-09-22
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the effect Of zoledronic acid on circulating and bone marrow-residing prostate cancer cells in patients with clinically localized prostate cancer


Eligibility criteria: Inclusion Criteria

* Prostate cancer
* Radical prostatectomy or external beam irradiation therapy within 6 months before study entry.
* No bone metastases according to bone scan

Exclusion Criteria

* Metastatic prostate cancer
* Hormone ablation therapy for more than 3 months before/after radical prostatectomy and external beam irradiation therapy
* Treatment with bisphosphonates or other drugs known to affect the skeleton within the past year.

Other protocol-defined inclusion / exclusion criteria may apply.

Primary outcomes:
measure: To assess the activity of one year treatment with zoledronic acid
timeFrame: 12 mos
Secondary outcomes:
measure: Three-year disease free survival
timeFrame: 3 years
measure: Change in bone mineral density at 12, 24 and 36 months versus baseline
timeFrame: 12, 24 and 36 months
measure: Changes in bone resorption markers at 12, 24 and 36 months versus baseline
timeFrame: 12, 24 and 36 months
measure: Safety and tolerability through abnormal values and AE reporting
timeFrame: upto 36 mos
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02612571: Comparing Rates of Glaucoma in Professional Wind Versus Non-Wind Instrument Players
Official title: Comparing Rates of Glaucomatous Optic Neuropathy in Professional Wind Versus Non-wind Instrument Players in the Philadelphia Orchestra
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Intraocular Pressure
Optic Neuropathy
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2015-11-24
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Current and retired members of the Philadelphia Orchestra who play or played wind and non-wind instruments for an average of 1 hour per day for a minimum of 5 years.

Brief summary: The purpose of the present study is to compare rates of glaucomatous optic neuropathy in professional wind versus non-wind instrument players in the Philadelphia Orchestra. A secondary objective is to evaluate intra-ocular pressure and choroidal thickness of wind instrument players under variable playing conditions.

Detailed description: Participants of this study will be any current or retired member of the Philadelphia Orchestra. Approximately 100 participants will be divided into 2 groups: 1) wind instrument players and 2) non-wind instrument players.

A wind instrument is defined as any instrument that contains a resonator, in which a column of air is set into resonation by the player blowing into a mouthpiece at one end of the resonator. A non-wind instrument is defined as any instrument that does not meet the wind instrument criteria.

On the day of the eye examinations, the investigator will provide a brief overview to explain the purpose and goals of the study to all potential participants. The examination team will be set up in an adjoining room. Members of the orchestra will be able to visit the examination team at any time during their practice session. A trained technician will perform the following for both eyes for all participants:visual acuity,undilated fundus color photography and intra-ocular pressure measurement. The investigators will record the examination findings using a standard form. Demographic information, including ocular, medical, social, and family history, will be documented for all participants.

Eligibility criteria: Inclusion Criteria:

* Play wind or non-wind instrument for average of 1 hour per day for minimum of 5 years.
* Normal general health.

Exclusion Criteria:

* Incisional eye surgery \<1 month prior to visit 1.

Primary outcomes:
measure: Intraocular pressure (IOP) in wind and non-wind instrument players
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
Study officials:
affiliation: Wills Eye Hospital
name: L J Katz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02516371: Lymphocytes Subpopulation in Cancer Patients
Official title: Lymphocytes Subpopulation and Its Relevance With Tumor Grade and Prognosis in Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2015-08-05
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to exam the subpopulation of lymphocytes and evaluate the clinico-pathologic correlations.

Detailed description: The host's inflammatory response in the tumor microenvironment could effect cancer progression and prognosis. As components of systemic inflammatory response, lymphocytes, neutrophils, and platelets are being recognised to have an important role in carcinogenesis and tumor progression. To date, a number of peripheral blood-derived inflammation-based scores such as the neutrophil-lymphocyte ratio (NLR), platelet- lymphocyte ratio (PLR) and so on have been proposed as prognostic markers in numerous types of cancers. But, very little is known of their impact in subpopulation of lymphocytes. The investigators try to evaluate the activity of lymphocytes in peripheral blood and find out the relationship among clinical prognosis.

Eligibility criteria: Inclusion Criteria:

1. cancer patients of Uijeongbu St. Mary's Hospital
2. never treated with chemotherapy
3. Age between 20\~80 years-

Exclusion Criteria:

1. treated with chemotherapy before
2. No informed consent form

Primary outcomes:
measure: response rate after cancer treatment with chemotherapy
timeFrame: 6 months after chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Uijeongbu city
country: Korea, Republic of
facility: Uijeongbu St. Mary's hospital, the Catholic university of Korea
state: Gyounggido
Study officials:
affiliation: Uijeongbu St. Mary's Hospital, The Catholic University of Korea
name: Yoon Ho Ko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02015871: An Extension Long-term Safety and Tolerability Trial of Degarelix in Chinese Patients With Prostate Cancer
Official title: An Extension Long-Term Safety and Tolerability Trial of Degarelix, Following a 1-year Open-Label, Multi-Centre, Randomised, Parallel-group Trial in Which the Efficacy and Safety of Degarelix One-month Dosing Regimen Was Compared With Goserelin in Chinese Patients With Prostate Cancer Requiring Androgen Ablation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-12-19
Enrollment: 206
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is an open-label, multi-centre, single arm extension for the 000006 trial in Chinese patients with prostate cancer. Eligible patients will receive monthly (28-day intervals) maintenance doses of 80 mg (20 mg/mL) degarelix administered by subcutaneous (s.c.) injection for a period of 2 years from first visit in this extension trial. Patients, who received goserelin treatment in the main trial, will get a degarelix starting dose (240 mg; 40 mg/mL) at the first visit and continue on degarelix treatment. The purpose of this 2-year extension trial is to collect long-term safety and tolerability data for the one-month dosing regimen.


Eligibility criteria: Inclusion Criteria:

* Has given written informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient
* Has completed the 000006 trial

Exclusion Criteria:

* Has been withdrawn/discontinued from the 000006 trial.

Primary outcomes:
measure: Number and percentage of patients with Adverse Events (AEs)
timeFrame: Baseline to Month 26
measure: Change in ECG parameters
timeFrame: Baseline to Month 26
measure: Change in body weight and vital signs
timeFrame: Baseline to Month 26
measure: Clinically significant changes in laboratory values (clinical chemistry, haematology, and urinalysis)
timeFrame: Baseline to Month 26
Secondary outcomes:
measure: Change in testosterone levels
timeFrame: Baseline to Month 26
measure: Change in prostate-specific antigen (PSA) levels
timeFrame: Baseline to Month 26
measure: Cumulative probability of no PSA failure
timeFrame: Baseline to Month 26
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital (there may be multiple sites in this country)
state: Beijing
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT01982071: A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia
Official title: A Multi-center, Open-label, Non-comparative Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia (CFDA Commitment)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Candidemia
Candidiasis
Keywords: Micafungin
candidiasis
candidemia
Open-label design
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2013-11-13
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of intravenous micafungin for the treatment of patients with proven or probable fungal infections caused by Candida sp. (Fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.


Eligibility criteria: Inclusion Criteria:

* The diagnosis criteria of probable candida infection: Risk factors + Clinical Manifestations + positive findings including microbiologic test
* The diagnosis criteria of proven candida infection: Risk factors + Clinical Manifestation + positive findings including microbiologic test + tissue culture or pathological examination results
* The following 3 criteria must be met is a patient is diagnosed as probable candida pneumonia:

  1. Risk factor (s) of infection
  2. Clinical manifestations of infection and the pulmonary infection cannot be explained by other pathogenic infections
  3. Two or more positive sputum culture for Candida

Exclusion Criteria:

* Patient received any other antifungal drug within 1 month prior to enrollment.
* HIV positive patient
* Patients with organ transplant
* Patients with agranulocytosis

Primary outcomes:
measure: Overall success rate
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Safety assessed by the incidence of adverse events
timeFrame: up to 10 weeks
Other outcomes:
Locations:
city: Beijing
country: China
city: Changsha
country: China
city: Chengdu
country: China
city: Fuzhou
country: China
city: Guangzhou
country: China
city: Harbin
country: China
city: Hengyang
country: China
city: Jinan
country: China
city: Nanjing
country: China
city: Shanghai
country: China
city: Shaoyang
country: China
city: Shenyang
country: China
city: Tianjin
country: China
city: Xi'an
country: China
city: Xiamen
country: China
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06888271: DNA Methylation in Brugada Syndrome and Risk of Sudden Cardiac Death
Official title: DNA Methylation in Brugada Syndrome and Risk of Sudden Cardiac Death (ANDROMEDA)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Brugada Syndrome
Sudden Cardiac Death Due to Cardiac Arrhythmia
Keywords: DNA methylation
Liquid biopsy
Sudden cardiac death
Brugada syndrome
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Brugada syndrome attended the Cardiology Dept. at University of Campania "L. Vanvitelli", Monaldi Hospital (Naples, Italy). The control group consisted of unrelated age- and sex-matched healthy subjects as volunteer blood donors attending the U.O.C. Divisione di Immunologia Clinica, Immunoematologia, Medicina Trasfusionale at University of Campania "L. Vanvitelli" (Naples, Italy).

Brief summary: The goal of this observational study is to evaluate if there are differences in DNA methylation of peripheral blood in patients with Brugada syndrome and healthy subjects. The main question it aims to answer is:

Does DNA methylation changes distinguish Brugada patients from healthy controls?

Does DNA methylation changes distinguish Brugada patients with high versus low risk of sudden cardiac death?

Detailed description: The Investigators will enroll 10 patients with Brugada syndrome and 10 age and sex matched healthy controls. We will collect 5 mL of peripheral blood and will analyze genome-wide DNA methylation via EPIC array platform. Bioinformatic algorithms and network analysis will be applied to identify possible diagnostic and predictive biomarkers.

Eligibility criteria: Inclusion Criteria:

* Brugada syndrome was confirmed when the 12-lead ECG showed ST-segment elevation with a type-1 morphology of ≥2 mm in ≥1 right precordial lead either spontaneously or after a provocative drug test (intravenous administration of a Class I antiarrhythmic) in the absence of any structural heart disease.
* \>18 years
* Unrelated patients

Exclusion Criteria:

* Related patients
* Not type 1 Br patter

Primary outcomes:
measure: Number of differentially methylated genes as assessed by EPIC microarray
timeFrame: 3 months
Secondary outcomes:
measure: Diagnostic performance of differentially methylated regions predicting the risk of sudden cardiac death
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Benincasa G, Pepin ME, Russo V, Cacciatore F, D'Alto M, Argiento P, Romeo E, Chiappetti R, Laezza N, Wende AR, Schiattarella GG, Coscioni E, La Montagna A, Amarelli C, Maiello C, Golino P, Condorelli G, Napoli C. High-resolution DNA methylation changes reveal biomarkers of heart failure with preserved ejection fraction versus reduced ejection fraction. Basic Res Cardiol. 2025 Apr;120(2):347-361. doi: 10.1007/s00395-024-01093-7. Epub 2024 Dec 27.
Clinical trial NCT02538588: Comparison of Amikacin Lung Delivery With Two Nebulizers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Cystic Fibrosis
Keywords: Healthy Volunteers
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2015-09-02
Enrollment: 12
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Comparison between two modalities of nebulization.


Eligibility criteria: Inclusion Criteria:

* Male healthy subjects
* Cystic fibrosis

Exclusion Criteria:

* Kidney failure
* No pregnancy

Primary outcomes:
measure: Total urinary concentration of amikacin
timeFrame: 24 hours after the nebulization
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT01229488: System for Ocular Oxygen Measurement
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Normal
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2010-10-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to demonstrate the ability of the OcuMetrics system to measure oxygen on the surface of the eye. Oxygen is important to the health of the cornea. The proposed instrument will take advantage of phosphorescent dyes that are sensitive to oxygen concentrations to monitor oxygen concentrations on the surface of the eye. This will have obvious applications in eye research and contact lens testing.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* contact lens wear in last 6 weeks
* Use of topical drugs

Primary outcomes:
measure: oxygen tension measurement by new device is comparable with gold standard, but less variable and faster.
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University School of Optometry
state: Indiana
Study officials:
References:
Clinical trial NCT01403688: Effects of Controlled Ovarian Hyperstimulation (COH) With Letrozole and Gonadotropin
Official title: Effects of Controlled Ovarian Hyperstimulation (COH) With Letrozole and Gonadotropin in Women at High Risk for Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Breast Cancer
Keywords: fertility high risk, controlled ovarian stimulation, breast cancer
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 9
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infertility Patients undergoing COH treatment and at high risk for breast cancer

Brief summary: Fertility drugs have the effect of increasing hormone levels. Higher hormone levels from infertility treatments may increase breast cancer risk, but there has not been enough research to know for sure. Researchers want to use a method of taking breast tissue cells from women who are having infertility treatment. The breast tissue cells might show changes that would indicate an increased risk of cancer. The method of taking the breast tissue cells is called Fine Needle Aspiration (FNA).

The purpose of this study is to examine the changes in breast tissue, in women at high risk of breast cancer who are being treated with controlled ovarian hyperstimulation.


Eligibility criteria: Inclusion criteria:

1. Women must be at increased risk for breast cancer based on any of the following criteria:

   * Age 30 or older with no prior live birth.
   * Mutations associated with hereditary cancer (BRCA1 or 2, P53, PTEN)
   * Family history of breast cancer including one first degree or multiple second degree relatives
   * History of chest radiation before age 30
   * Multiple prior breast biopsies
   * Precancerous conditions (DCIS, LCIS, AH)
   * Prior history of breast or ovarian cancer
   * Estimated mammographic breast density \> 50%
2. Must be undergoing infertility treatment at the University of Kansas with Controlled Ovarian Hyper-stimulation (COH)
3. Must be between the ages of 21-45 (both inclusive) with Day 3 FSH less than 12 IU/L, Day 3 E2 less than 80 pg/ml

Exclusion criteria:

1. Women under 21 or over 45 years old
2. Day 3 FSH over 12 IU/L, Day 3 E2 over 80 pg/ml
3. Women who do not meet risk criteria above
4. History of hypersensitivity to letrozole or gonadotropin
5. Uterine and adnexal pathology
6. Use of clomid or gonadotropin within 30days before the letrozole cycle
7. Any severe chronic disease of relevance for reproductive function

Primary outcomes:
measure: evaluation with pre- and post-treatment(COH) breast cytomorphometry and biomarkers
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: The University of Kansas Medical Center
name: Samuel Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04444388: Effect of Cocoa Supplementation in Training Athletes Microbiota and Metabolome
Official title: Effect of Cocoa Supplementation in Training Athletes Microbiota and Metabolome: Effects on Acute and Adaptive Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Athletes
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: It has recently been suggested that cocoa may improve exercise performance and recovery. This study aim to evaluate the plasma and fecal metabolome after 10 weeks of cocoa supplementation during the training period in recreational athletes to detect possible metabolites involved in the observed benefits of cocoa in athletes


Eligibility criteria: Inclusion Criteria:

* 18-45 years of age
* high physical condition (VO2 ≥ 55 ml/kg/min)
* BMI 18-25 kg/m2

Exclusion Criteria:

* antibiotics intake during 3 months prior to the study,
* smoking
* nutritional complements
* ergogenic complements
* prebiotics
* probiotics
* vegetarian or vegan diet
* chronic medication
* gastrointestinal surgery
* Any diagnosed disease

Primary outcomes:
measure: Fecal microbiota
timeFrame: Changes from baseline to 10 weeks of intervention
measure: Fecal metabolome profile
timeFrame: Changes from baseline to 10 weeks of intervention
measure: Plasma metabolome profile
timeFrame: Changes from baseline to 10 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Villaviciosa de Odón
country: Spain
facility: Universidad Europea de Madrid
state: Madrid
Study officials:
affiliation: Universidad Europea de Madrid
name: Mar Larrosa, PhD
role: PRINCIPAL_INVESTIGATOR
References: