louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01778842: Standard Clopidogrel Versus Prasugrel Low Dose Therapy in Elderly Patients With Acute Coronary Syndrome
Official title: PhaRmacodynamic Effect of Antiplatelet Agents in Elderly Patients: Standard Clopidogrel Versus prasugrEl Low Dose Therapy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: antiplatelet effect
prasugrel
clopidogrel
acute coronary syndrome
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2013-01-29
Enrollment: 68
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The elderly represent a growing segment of the coronary population treated by dual antiplatelet therapy for percutaneous coronary intervention (PCI). These patients bear a higher risk of both ischemic events and bleeding complications than younger patients, with a subsequently higher rate of mortality.Recentprogress in antithrombotic treatment demonstrated the efficacy of adding a P2Y12 receptor antagonist to low-dose aspirin. Whether this benefit is also present in the elderly remains a debated issue due to the lack of specific data in this sub-population. The present study was realized to provide specific data on platelet response to clopidogrel, standard dose (75 mg) or prasugrel 5 mg in elderly patients (≥75 years old) whereas the superiority in PR response of the latter should allows the Prasugrel therapy in elderly patients with the better clinical efficacy and therapeutical safety already showed compared with Clopidogrel.


Eligibility criteria: Inclusion Criteria:

* Acute coronary syndrome
* PCI with stent implantation
* clopidogrel responsiveness
* \> 75 years of age.

Exclusion Criteria:

* history of bleeding diathesis
* chronic oral anticoagulation treatment
* contraindications to antiplatelet therapy
* PCI or coronary artery bypass grafting (CABG) \< 3 months
* hemodynamic instability
* platelet count \< 100,000/μl
* hematocrit \< 30%
* creatinine clearance \< 25 ml/min
* Patients with a history of stroke
* other contraindication for prasugrel administration
* patients weighing \< 60 kg
* high on treatment platelet reactivity

Primary outcomes:
measure: superiority of prasugrel low dose
timeFrame: 30 days
Secondary outcomes:
measure: Bleeding
timeFrame: 12 months
measure: major adverse cardiac events
timeFrame: 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Dept.of Cardiovascular Sciences,Policlinico Umberto I
Study officials:
References:
Clinical trial NCT00740142: Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy
Official title: Efficacy of Combined Oral L-ornithine-L-aspartate and Oral Lactulose in Patients With Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatic Encephalopathy
Keywords: L ornithine L aspartate
Lactulose
Hepatic encephalopathy
LOLA
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2008-08-22
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: Is the combination of oral L-ornithine-L-aspartate and lactulose more efficacious than oral lactulose alone in treatment of hepatic encephalopathy? Study design; Randomized, double-blinded, placebo controlled trial

Detailed description: Data collection

1. Baseline characteristics

   * demographic data; age, gender, BW, height
   * cirrhosis; cause, duration, Child-Pugh score,complications of cirrhosis such as EV, ascites, hepatic encephalopathy, SBP etc.
   * comorbidity such as DM, CVA
2. After randomization

   * assessment of mental status (West-Haven criteria), Portal-systemic encephalopathy index (PSEI), number connection test, serum ammonia, asterixis at Day 1,3,7 and EEG at day 1,7
   * blood chemistry such as CBC, BUN, Creatinine, electrolyte, LFT, coagulogram, BS at Day 1,3,7
   * record adverse effect of drug such as nausea, vomiting, bloating.
   * record diet, frequency of bowel movement and stool pH
   * compliance

Eligibility criteria: Inclusion Criteria:

* Cirrhosis
* Age 18-80
* Hepatic encephalopathy grade II-III
* Serum ammonia \> 60 mcg/mL
* Informed consent

Exclusion Criteria:

* Recent GI hemorrhage
* Severe sepsis
* Degenerative CNS disease or major psychiatric illness
* Serum creatinine \> 1.5 mg/dl
* Pregnancy or lactation
* Poorly controlled DM
* Insertion of TIPS
* Received CNS depressants or hypnotics
* Treatment with metronidazole, kanamycin or branched-chain amino acid
* Hypersensitivity to L-ornithine-L-aspartate

Primary outcomes:
measure: To assess improvement of mental status of the patients
timeFrame: 7 days
Secondary outcomes:
measure: To assess improvement of number connection test, serum ammonia, EEG, asterixis and PSE index of the patients
timeFrame: 7 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Siwaporn Chainuvati, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01379742: Comparison of Between ThinSeed™ and OncoSeed™ for Permanent Prostate Brachytherapy
Official title: Comparison of Health Related Quality of Life and Other Clinical Parameters Between ThinSeed™ and OncoSeed™ for Permanent Low Dose Rate Implantation in Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: prostate cancer
prostate brachytherapy
Lead sponsor: Prostate Cancer Foundation of Chicago
Sponsor class: OTHER
First posted: 2011-06-23
Enrollment: 240
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate health related quality of life factors in patients undergoing low dose rate prostate brachytherapy. Patients will be randomized to Iodine-125 Thinstrand (for use with 20 g needles) or Rapidstrand (for use with standard 18 g needles). Urinary, bowel, sexual function and bother will be measured by the EPIC questionnaire at various time intervals.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate, clinical stage T1c - T2b, N0, M0
* Greater than or equal to 40 years of age
* Low and Low- Intermediate Risk prostate cancer
* Prostate volumes by TRUS ≤ 60 cc
* I-PSS score \< 25 (alpha blockers allowed)
* Signed study-specific informed consent form prior to study entry

Exclusion Criteria:

* Lymph node involvement (N1)
* Evidence of distant metastases (M1)
* Radical surgery for carcinoma of the prostate
* Prior pelvic radiation
* Major medical or psychiatric illness, which in the investigator's opinion would prevent completion of treatment and would interfere with follow- up or ability to complete questionnaires
* Hip prosthesis
* Inability or refusal to provide informed consent
* Evidence of Previous TURP
* Prior hormone therapy
* Prior TURP

Primary outcomes:
measure: Health related quality of life including urinary, bowel and sexual function as measured by the EPIC questionnaire
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Westmont
country: United States
facility: Chicago Prostate Center
state: Illinois
Study officials:
affiliation: Chicago Prostate Center
name: Brian J Moran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00802542: In-practice Evaluation of Atacand 16mg Antihypertensive Effect
Official title: In-practice Evaluation of Atacand 16mg Antihypertensive Effect
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Essential Hypertension
Keywords: Hypertension
blood pressure
Atacand
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: out-patient departments

Brief summary: The purpose of this study is to prove in practice the effectiveness of Atacand 16 mg in reducing blood pressure after 4 weeks of administration and the importance of administration of adequate doses


Eligibility criteria: Inclusion Criteria:

* Adult patients with mild (140-159/90-99 mgHg) to moderate (160-179/100-109 mmHg) essential hypertension, already treated with Atacand 8mg for 2-4 weeks, who have not reached the blood pressure treatment goal at least \<140/90 mgHg and the doctor has decided
* Signed and dated Patient Informed Consent (ICF)

Exclusion Criteria:

* Hypersensitivity to the active substance or to any of the excipients of Atacand.

Primary outcomes:
measure: Decrease in blood pressure
timeFrame: once after 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Daugavpils
country: Latvia
facility: Research site
city: Jelgava
country: Latvia
facility: Research site
city: Liepaja
country: Latvia
facility: Research site
city: Riga
country: Latvia
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Agrita Hartmane
role: STUDY_DIRECTOR
References:
Clinical trial NCT02209142: Blood Biomarkers in Major Depression
Official title: Blood Biomarkers in Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Major depression
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2014-08-05
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Depression is a leading cause of disability worldwide, affecting nearly 16% of the general population. Its physiopathology remains unclear. Based on gene-environment studies and epigenetic studies, a main hypothesis proposed that the major depressive episode (MDE) results from the convergence of multiple factors including biological factors such as multi-genic vulnerability, hormonal and immunological variations as well as environmental factors. As a consequence, mRNA could define a biological signature of the MDE.


Eligibility criteria: Inclusion Criteria:

* Major depressive disorder at inclusion according to the DSM IV at the time of the inclusion,

  * Having a score on the scale of depression of Hamilton ( HDRS-17) \> 19 at the time of the inclusion,
  * Taken care by a grown-up psychiatric department, that the coverage(care) is realized in ambulatory or during a hospitalization

Exclusion Criteria:

* Schizophrenia

Primary outcomes:
measure: describe a transcriptional signature of the Major Depressive Episode.
timeFrame: 6 months
Secondary outcomes:
measure: evaluate the role played by confounding factors as genetic polymorphisms,
timeFrame: 6 months
Other outcomes:
measure: evaluate the role played by confounding factors as immune phenotype
timeFrame: 6 months
measure: evaluate the role played by confounding factors as psychotropic medications
timeFrame: 6 months
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: jean Naudin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Belzeaux R, Gorgievski V, Fiori LM, Lopez JP, Grenier J, Lin R, Nagy C, Ibrahim EC, Gascon E, Courtet P, Richard-Devantoy S, Berlim M, Chachamovich E, Theroux JF, Dumas S, Giros B, Rotzinger S, Soares CN, Foster JA, Mechawar N, Tall GG, Tzavara ET, Kennedy SH, Turecki G. GPR56/ADGRG1 is associated with response to antidepressant treatment. Nat Commun. 2020 Apr 2;11(1):1635. doi: 10.1038/s41467-020-15423-5.
Clinical trial NCT02712242: PRF for Accelerating Palatal Healing
Official title: The Effects of Platelet-Rich Fibrin on Palatal Wound Healing After Free Gingival Graft Harvesting: A Comparative Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 125
Sex: ALL
Minimum age (years): 21
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Backgroung: Various agents are used to reduce post-operative complications associated with palatal donor site surgery for free gingival graft (FGG) harvesting. This study was conducted to evaluate the effects of platelet-rich fibrin (PRF) on palatal wound healing.

Detailed description: 125 patients with isolated recessions were treated. The connective tissue graft was obtained by the de-epithelialization of a free gingival graft in both groups. Three different hemostatic treatments were randomized; PRF with cyanoacrilate adhesive (PRF group, n:42), cyanoacrilate adhesive alone (BC group, n:42) and sterile wet gauze compression (WG group, n:41). Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded for different time points.

Eligibility criteria: Inclusion Criteria:

* no contraindications for periodontal surgery;
* full-mouth plaque score of \<10%
* full-mouth bleeding score of \<15%.

Exclusion Criteria:

* previously undergone surgery for a graft harvested from the palate
* presence of systemic disease or taking medication known to interfere with periodontal health
* smokers
* possible coagulation disorders

Primary outcomes:
measure: Epithelialization
timeFrame: One month
Secondary outcomes:
measure: Sensibility disorders
timeFrame: One month
measure: feeding habits
timeFrame: One month
measure: Delayed bleeding
timeFrame: 1 week
measure: Immediate Bleeding
timeFrame: 1 hour
measure: Pain
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Cukurova University, Professor
name: Onur Ozcelik, Ph D
role: STUDY_DIRECTOR
References:
Clinical trial NCT00619242: The Effects of Sorafenib on Molecular Barrett's Esophagus Cancer
Official title: A Pilot Study of the Effect of Sorafenib on Molecular Biomarkers in Barrett's Esophagus With High Grade Dysplasia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Esophageal Cancer
Keywords: Esophageal cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2008-02-20
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine whether sorafenib is able to change pre-cancerous cells in a way that we believe is important in the progression of cancer.

Detailed description: To characterize the effects of sorafenib on specific molecular markers in patients with Barrett's esophagus and high grade intraepithelial neoplasia (HGIN) or carcinoma in situ (CIS).

Eligibility criteria: Inclusion Criteria:

* ECOG performance status 0-2
* Life expectancy of greater than 12 months
* No prior history of esophageal surgery or endoscopic treatment of dysplasia
* No prior exposure to sorafenib
* Patients may not be receiving any other investigational agents or any concomitant antineoplastic therapy, with the exception of androgen ablating agents (for patients with prior prostate cancer)
* Age 18 years.
* Patients must have adequate organ and marrow function as defined below:

  * hemoglobin: 8.5 g/dL
  * absolute neutrophil count: 1,500/L
  * platelets: 100,000/L (greater than 35,000/L without transfusion for less than 1 X the institutional upper limit of normal)
  * creatinine less than 1.5 X institutional upper limit of normal
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* A patient will be withdrawn from the study if any of the following events occur while on therapy:

  * Interruption of scheduled therapy for greater than 7 days
  * Intolerable adverse effects which are judged by the investigator to be either physically or psychologically detrimental to the patient
  * Patient decision to discontinue treatment
  * Pregnancy
  * Patient non-compliance with therapy administration
  * Grade 3 or 4 NCI-CTC toxicity attributable to sorafenib
  * Treatment with other chemotherapeutic or investigational anti-neoplastic drugs
  * Disease progression
* HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with sorafenib.Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.

Primary outcomes:
measure: Ki-67
timeFrame: Two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Ezra Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00815542: Induction of Labor in Oligohydramnios
Official title: Induction of Labor in Oligohydramnios - A Comparison Between Two Modes of Cervical Ripening for Patients With Oligohydramnios at Term
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cervical Ripening
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2008-12-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: When oligohydramnion - decreased amniotic fluid, is diagnosed at term pregnancies, the common practice is to induce labor. Whenever the cervix is not ripened, there are several methods to ripen the cervix, two of which are: mechanical, using a double balloon catheter and pharmacological, with prostaglandins. The aim of the study is to compare those two methods of cervical ripening for patients with significant oligohydramnion at term.

The study will be a prospective randomised trial.


Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* normal pregnancy, well dated, at term
* un ripened cervix

Exclusion Criteria:

* previous cesarean section
* multiple pregnancy
* intra uterine growth restricted fetus

Primary outcomes:
measure: Time from ripening to active labor and to delivery, rates of cesarean section, rates of nonreassuring fetal heart rate during induction of labor.
timeFrame: during induction of labor, delivery and early post partum
Secondary outcomes:
measure: patients satisfaction
timeFrame: induction of labor, delivery and early postpartum
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medial Center
Study officials:
affiliation: Meir Medical Center, Kfar Saba, Israel, Affiliated to Tel Aviv University
name: Tal Biron - Shental, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01683942: A New Reproducible Method of Measuring C/D Ratio of Digital Stereo Images of Optic Disc
Official title: A New Reproducible Method of Measuring C/D Ratio of Digital Stereo Images of Optic Disc
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Developing Novel Technique of Measuring C/D Ratio From Digital Stereo Optic Disc Images
Intraobserver Reproducibility of C/D Measurements
Interobserver Variability of C/D Measurements
Keywords: cup disc ratio measurement
digital stereo optic disc images
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2012-09-12
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 500 consecutive digitalized optic disc photos of 250 patients attending the Glaucoma Service between 1996-2012 will be extracted from a database of optic disc photos at the Glaucoma Service of the Ophthalmology Department, Meir Medical Center, Kfar Saba, Israel.

Brief summary: Development of a novel computer software that will assist in measuring the cup/disc ratio in digital stereo optic disc images.


Eligibility criteria: Inclusion Criteria:

Patients who attended the Glaucoma service Patients with at least one pair of documented digital stereo optic disc images Satisfactory Quality of image allowing Cup Disc Ratio Evaluation

Exclusion Criteria:

Unsatisfactory Quality of image allowing Cup Disc Ratio Evaluation Novel software technique unable to process or analyze the image

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03160742: Pilot Study of a Non-Invasive Central Venous Pressure Monitoring System in Children
Official title: Pilot Study of a Non-Invasive Central Venous Pressure Monitoring System in Children
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Central Venous Pressure
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Mespere Lifesciences Inc.
First posted: 2017-05-19
Enrollment: 1
Sex: ALL
Minimum age (years): 12
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 children ages 12 months to 10.9 years scheduled to undergo a cardiac surgery with central venous pressure catheter monitoring at Boston Children's Hospital.

Brief summary: The goal of this research study is to determine the feasibility and accuracy of Mespere Life Science non-invasive central venous pressure monitoring system (Mespere VENUS 2000CVP system) in children with congenital heart disease (CHD).

Detailed description: Central venous pressure (CVP), also known as right atrial pressure (RAp), is a reflection of the right heart filling pressure i.e the preload of the right ventricle. Assessment of the CVP is essential in the management of different clinical situations in children. Invasive CVP monitoring by placement of a CVP catheter either in the internal jugular vein or the subclavian vein is the gold standard way of measuring the CVP both in children and adults. However, placing a CVP catheter in a child can be challenging, time consuming, often requires the child to be sedated and it is not without complications.

Being able to reliably measure the CVP noninvasively would be of great benefit for sick children as it may allow diagnoses to be made quickly and help guide treatment.

The goal of this proposal is to determine the feasibility and accuracy of Mespere Life Science non-invasive central venous pressure monitoring system (Mespere VENUS 2000CVP system) in children with congenital heart disease (CHD).

Eligibility criteria: Inclusion Criteria:

* 12 months of age to 10.9 years of age
* Scheduled to undergo a cardiac surgery with central venous pressure catheter monitoring at Boston Children's Hospital

Exclusion Criteria:

* undergo a procedure that does not require a central venous pressure catheter as part of routine monitoring
* Have a known venous occlusion or any other reason the central venous pressure may be unreliable
* Allergy to medical grade adhesives or have any pre-existing skin irritation/eczema at the sensor site
* Emergently scheduled procedures

Primary outcomes:
measure: Accuracy of Mespere VENUS 2000CVP
timeFrame: The data will be collected for the length of the cardiac surgery, up to 6 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Kirsten Odegard, MD
role: PRINCIPAL_INVESTIGATOR
References: