louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01380925: The Jewels in Our Genes Study - an African American Family Study of Breast Cancer
Official title: Search for Novel Breast Cancer Susceptibility Genes in Pedigrees of African Ancestry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: University at Buffalo
Sponsor class: OTHER
Collaborators: name: Susan G. Komen Breast Cancer Foundation
First posted: 2011-06-27
Enrollment: 330
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: African American breast cancer survivors.

Brief summary: The research team is studying why some African American families have multiple cases of breast cancer.

This study will help to better understand if there are undiscovered genes unique to African Americans that may predict early breast cancer risk.

Breast cancer survivors AND their relatives who are also breast cancer survivors are being recruited to the study.


Eligibility criteria: Inclusion Criteria:

* Black/African American
* Ever diagnosed with breast cancer
* Have at least one living blood relative ever diagnosed with breast cancer, who is also willing to participate
* Live in the U.S.

Exclusion Criteria:

* Tested positive for BRCA mutations

Primary outcomes:
measure: breast cancer
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
References:
citation: Ochs-Balcom HM, Sun X, Chen Y, Barnholtz-Sloan J, Erwin DO, Jandorf L, Sucheston-Campbell L, Elston RC. Putative linkage signals identified for breast cancer in African American families. Cancer Epidemiol Biomarkers Prev. 2015 Feb;24(2):442-7. doi: 10.1158/1055-9965.EPI-14-1131. Epub 2014 Dec 4.
Clinical trial NCT01761825: The Effect of Ivabradine on Patients With Postural Tachycardia Syndrome
Official title: The Effect of "Funny" Channel Blocker Ivabradine on Patients With Postural Tachycardia Syndrome.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Postural Tachycardia Syndrome
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-01-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Ivabradine is an effective treatment for postural tachycardia syndrome.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with POTS by the following criteria:

  1. The presence of characteristic orthostatic symptoms of the POTS for at least six months.
  2. An increase in the heart rate of at least 30 beats per minute (without concomitant significant decrease in blood pressure of more than 20/10 mmHg) within 10 minutes after assuming a standing position (or during tilt test) on at least 3 separate occasions.
  3. No other concomitant diseases that could explain the symptoms of POTS.

     Exclusion Criteria:

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  1. History of systemic illness capable of affecting of affecting autonomic function (eg, diabetes mellitus, SLE).
  2. History of cardiovascular disease.
  3. History of smoking, drug or alcohol abuse.
  4. Pregnancy, and also uncontrolled thyroid or adrenal disorders.
  5. Using any drug metabolized by cytochrome P450 3A4 enzyme during the last 72 hours.

Primary outcomes:
measure: the change in heart rate after the administration of Ivabradine
timeFrame: 60 minutes , during the whole trial
measure: the change in blood pressure after the administration of Ivabradine
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00771225: National,Multicentric Randomised Study of the Correction of Genital Prolapse With Fascial Repair or Mesh-Prolift
Official title: A National Multicentric Randomised Study of the Correction of Genital Prolapse With Fascial Repair or Mesh (Prolift)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Genital Prolapse
Keywords: genital prolapse
surgery
fascial repair
mesh
prolift
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo General Hospital
name: Irmandade da Santa Casa de Misericordia de Sao Paulo
name: Federal University of São Paulo
name: Feculdade de Medicina da Universidade de Sao Paulo - Brasil
First posted: 2008-10-13
Enrollment: 180
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 180 women with genital prolapse will be submitted to genital prolapse surgical correction, half of them with human fascia, and the other half with Prolift.

Detailed description: 180 women with genital prolapse will be submitted to genital prolapse surgical correction, half of them with human fascia, and the other half with Prolift.Are eligible women aged between 50 and 80 years old.

Eligibility criteria: Inclusion Criteria:

* Between 50 and 80 yrs

Exclusion Criteria:

* Less than 50 and more than 80 yrs

Primary outcomes:
measure: Correction of genital prolapse
timeFrame: 8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Simone Brandao
Study officials:
affiliation: University of Sao Paulo
name: Simone Brandao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00517725: Nebivolol Versus Bisoprolol Versus Carvedilol in Heart Failure
Official title: Nebivolol Versus Bisoprolol Versus Carvedilol in Heart Failure: Effects on Exercise Capacity and Hypoxia, Chemoreceptor Response, Pulmonary Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Heart Failure
Keywords: exercise
lung diffusion
hypoxia
chemoreceptor
beta-blockers
heart failure
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
First posted: 2007-08-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators test the hypothesis that different beta-blockers had a different influence on chemoreceptor response and lung diffusion capacity.

Both could influence exercise capacity in normoxic as well as hypoxic conditions.


Eligibility criteria: Inclusion Criteria:

* Chronic heart failure patients in stable clinical condition

Exclusion Criteria:

* No comorbidity
* NYHA class IV

Primary outcomes:
measure: exercise capacity
timeFrame: two months
Secondary outcomes:
measure: lung diffusion
timeFrame: two months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Centro Cardiologico Monzino, University of Milan
Study officials:
affiliation: Centro Cardiologico Monzino
name: Piergiuseppe Agostoni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Cardiologico Monzino
name: Giancarlo Marenzi, MD
role: STUDY_CHAIR
References:
citation: Agostoni P, Bussotti M, Cattadori G, Margutti E, Contini M, Muratori M, Marenzi G, Fiorentini C. Gas diffusion and alveolar-capillary unit in chronic heart failure. Eur Heart J. 2006 Nov;27(21):2538-43. doi: 10.1093/eurheartj/ehl302. Epub 2006 Oct 6.
citation: Karsten M, Contini M, Cefalu C, Cattadori G, Palermo P, Apostolo A, Bussotti M, Magri D, Salvioni E, Farina S, Sciomer S, Catai AM, Agostoni P. Effects of carvedilol on oxygen uptake and heart rate kinetics in patients with chronic heart failure at simulated altitude. Eur J Prev Cardiol. 2012 Jun;19(3):444-51. doi: 10.1177/1741826711402736. Epub 2011 Mar 7.
Clinical trial NCT04790825: Periodontal Therapy on the Gut Microbiome of Inflammatory Bowel Disease
Official title: Effect of Intensive or Conventional Periodontal Therapy on the Gut Microbiome and Systemic Inflammation of Patients With Inflammatory Bowel Disease: a Single-blinded Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontal Diseases
IBD
Dysbiosis
Inflammation
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Periodontitis and inflammatory bowel disease have been associated by meta-epidemiologic evidence, although their mechanistic connection needs to be further explored. Oral-gut axis is implicated in the pathogenesis of several chronic inflammatory conditions, but to date no studies have evaluated the impact of periodontal treatment on gut ecology. Thus, the present randomised clinical trial is aimed at investigating the effect of intensive or conventional periodontal therapy on the gut microbiome and parameters of systemic inflammation of patients diagnosed with inflammatory bowel disease.


Eligibility criteria: Inclusion Criteria:

* clinical and instrumental diagnosis of ulcerative colitis or Crohn's disease
* periodontitis Stage III or IV
* BMI between 20 and 29 kg/m2
* free diet
* presence of at least 20 teeth

Exclusion Criteria:

* Systemic diseases (including diabetes, thyroid, liver, or kidney diseases)
* dietary allergies
* use of antibiotics or probiotics during the previous 30 days
* pregnancy or breast feeding

Primary outcomes:
measure: Changes in microbiome alpha diversity measured from stool samples at 3 months
timeFrame: Baseline and 90 days
Secondary outcomes:
measure: Changes in microbiome alpha diversity measured from saliva samples at 3 months
timeFrame: Baseline and 90 days
measure: Change of the inflammatory markers levels in plasma
timeFrame: Baseline and 90 days
measure: Changes in mean clinical attachment level (CAL) at 3 months
timeFrame: Baseline and 90 days
measure: Changes in periodontal pocket depth (PPD) at 3 months
timeFrame: Baseline and 90 days
measure: Changes in full mouth bleeding score (FMBS) at 3 months
timeFrame: Baseline and 90 days
Other outcomes:
Locations:
city: Turin
country: Italy
facility: CIR Dental School
Study officials:
References:
Clinical trial NCT06341725: EUS Role in Non-metastatic Pancreatic Adenocarcinoma Lymph Nodes Staging
Official title: Role of Endoscopic Ultrasound to Assess the Lymph Nodes Staging in Non-metastatic Pancreatic Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pancreatic Adenocarcinoma
Lymph Node Metastasis
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pancreatic adenocarcinoma stage I-II and III with malignant lymph nodes assessed by EUS and elastography

Brief summary: Aim of the study will be to investigate if Endoscopic Ultrasound (EUS) with elastography can be purposed between the routine staging examinations in patients with pancreatic adenocarcinoma without distant metastasis for the staging of lymph nodes status ("N" in TNM classification)

* in RESECTABLE pancreatic cancer the investigators will evaluate the concordance with EUS elastography and histological findings of lymph nodes obtained during surgery, in order to assess the sensibility, specificity and the positive and negative predictive value of EUS with elastography, the disease-free survival, the percentage of metastatic patients and the overall survival (in patients with or without metastatic lymph nodes).
* in "BORDERLINE resectable" and UNRESECTABLE non-metastatic ("advanced" locally") disease, the investigators will evaluate if the malignant lymph nodes samples during EUS with elastography and fine needle aspiration (FNA) will be related to a decreased survival.

Secondary aim will be to register the prognosis (in terms of survival) of the patients with para-aortic and mediastinal pathological lymph nodes (related to a decreases survival in some series in literature)

Detailed description: Pathological lymph nodes will be assessed by EUS with elastography as lymph nodes: hypoechoic, rounded, rigid (blue) and big (bigger than 1 centimeter)

Eligibility criteria: Inclusion Criteria: pancreatic adenocarcinoma without distant metastasis; patients \> 18 years

Exclusion Criteria: distant metastasis and pancreatic adenocarcinoma

Primary outcomes:
measure: CONCORDANCE (PERCENTAGE) of pathological lymph nodes at EUS with elastography and surgical pathology report
timeFrame: 2 years
measure: OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence
timeFrame: 2 years
measure: OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence
timeFrame: 2 years
Secondary outcomes:
measure: OVERALL SURVIVAL (MONTHS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Hospital
Study officials:
References:
Clinical trial NCT04087525: A Study to Evaluate the Pharmacokinetics and Safety of HIP1701 in Healthy Subjects
Official title: A Randomized, Open-Label, Single-Dose, Two-way Crossover Study to Compare Pharmacokinetic Properties and Safety of HIP1701 and HGP1809 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Health, Subjective
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2019-09-12
Enrollment: 31
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics and safety of HIP1701 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Age 19\~55 years in healthy volunteers
2. BMI is more than 18.5 kg/m\^2 , no more than 24.9 kg/m\^2
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
2. Subjects who judged ineligible by the investigator

Primary outcomes:
measure: Cmax of Vildagliptin
timeFrame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
measure: AUClast of Vildagliptin
timeFrame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
Secondary outcomes:
measure: AUCinf of Vildagliptin
timeFrame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
measure: Tmax of Vildagliptin
timeFrame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
measure: t1/2 of Vildagliptin
timeFrame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
measure: CL/F of Vildagliptin
timeFrame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
measure: Vd/F of Vildagliptin
timeFrame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
References:
Clinical trial NCT00615225: Brain Death: Inflammatory Response, Apoptosis, and Endotoxin Tolerance
Official title: Observational Study on the Systemic Inflammatory Response During Brain Death.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Death
Keywords: brain death
inflammation
endotoxin
transplantation
graft
apoptosis
Systemic inflammatory response
Apoptosis activation
Graft outcome
Lead sponsor: Delafontaine Hospital
Sponsor class: OTHER
First posted: 2008-02-14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any brain dead patients diagnosed in three different ICUs

Brief summary: We hypothesized that brain death is associated with an early systemic inflammatory response, possibly combined with activation of apoptotic cell death, two events that may contribute to induce rapid organ dysfunction. In this study of brain-dead donors and controls, we assayed plasma cytokines and soluble factors, investigated plasma endotoxin levels as a triggering factor for inflammation, measured ex vivo cytokine production by blood leukocytes to determine whether immunosuppression occurred after brain death, and examined skeletal muscle biopsies to look for evidence of inflammation and increased apoptosis in peripheral tissue.


Eligibility criteria: Inclusion Criteria:

* All brain dead patients whatever the cause (cardiac arrest, stroke, head trauma)

Exclusion Criteria:

* Age \< 18years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Liege Hospital
city: Paris
country: France
facility: Tenon Hospital
city: Saint Denis
country: France
facility: Delafontaine Hospital
Study officials:
affiliation: Delafontaine Hospital
name: Christophe Adrie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pasteur Institute
name: Jean Marc Cavaillon, ScD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00673725: Locobase® REPAIR Used as an Adjunctive to Standard Therapy in Children With Moderate to Severe Atopic Dermatitis
Official title: A Phase IV,Open Label Study of the Treatment of Children With Moderate to Severe Atopic Dermatitis (AD) Using Locobase® REPAIR as an Adjunctive to Standard Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dermatitis, Atopic
Keywords: Atopic Dermatitis
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-05-07
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the efficacy of Locobase REPAIR® when used in children with moderate to severe AD


Eligibility criteria: Inclusion Criteria:

* Has given written informed consent (parents or guardian, child if applicable)
* Moderate to severe AD
* Continuous use of topical corticosteroid or topical calcineurin inhibitor (TCI) as active treatment of AD for more than 4 weeks prior to screening (no change in topical corticosteroid or TCI is allowed between screening and day 1)
* In the opinion of the investigator, subject is unlikely to require a significant change to his/her current treatment regimen during the study period

Exclusion Criteria:

* Has infected lesions
* The last assessment of any clinical study within 3 months prior to the expected date of entering into the study
* Current use of Locobase® REPAIR
* Known allergy to Locobase® REPAIR or any of its components
* Any clinical condition which, in the opinion of the investigator, would not allow safe completion of the study

Primary outcomes:
measure: Change in mEASI from baseline to week 3
timeFrame: 3 Weeks
Secondary outcomes:
measure: Physicians Global Evaluation of Clinical Response
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
city: Manchester
country: United Kingdom
city: Reading
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT02456025: Topical Tacrolimus in Vernal Keratoconjunctivitis
Official title: Topical Tacrolimus in Vernal Keratoconjunctivitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vernal Keratoconjunctivitis
Lead sponsor: The Eye Center and The Eye Foundation for Research in Ophthalmology
Sponsor class: OTHER
First posted: 2015-05-28
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim of this study is to evaluate the efficacy and safety of topical tacrolimus 0.01% eyedrops in patients with vernal keratoconjunctivitis.

Detailed description: A total of 20 patients with bilateral symmetrical vernal keratoconjunctivitis will be included. Each patient will undergo a complete ophthalmologic evaluation. Patient will be placed at random on topical Tacrolimus 0.01% ophthalmic solution in one eye and placebo eyedrops in the fellow eye. Patients will undergo ophthalmologic examination at one week and after one month. Photos will be taken. The outcome measures include graded symptoms, graded signs, and laboratory investigations. Symptoms of itching, redness, foreign body sensation, tearing and discharge following will be recorded before and after treatment. The grading of clinical signs of conjunctival hyperemia, conjunctival papillary hypertrophy, perilimbal infiltrates, Trantas dots, superficial punctate keratopathy will be recorded before and after treatment. Conjunctival surface temperature will be determined before and after treatment. Conjunctival scrapings will be stained with Giemsa and will be assessed before and after therapy and number of eosinophils per hpf will be determined and recorded.

Eligibility criteria: Inclusion Criteria:

* with bilateral symmetrical palpebral and limbal vernal keratoconjunctivitis
* Patients 6-18 years of age

Exclusion Criteria:

* Pregnant patients
* Patients on systemic therapy for other allergic disorders
* Patients who cannot come for follow-up
* Patients who are on other topical medications for other comorbid ocular conditions

Primary outcomes:
measure: The efficacy of Topical Tacrolimus in Vernal Keratoconjunctivitis
timeFrame: Five months
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: The Eye Center
Study officials:
affiliation: THE EYE CENTER
name: Samir S Shoughy
role: PRINCIPAL_INVESTIGATOR
References: