louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00370513: A Phase I Study of Pazopanib in Adult Patients With Liver Cancer
Official title: A Phase I, Open-Label, Dose-Escalation, Multi-Center Study or Pazopanib (GW786034) in Adult Patients With Hepatocellular Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma, Hepatocellular
Keywords: pazopanib
liver cancer
hepatocellular cancer
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-31
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Liver cancer is a good target for anti-angiogenic treatments such as pazopanib. The effect of pazopanib in patients with liver cancer are unknown. This study is designed to evaluate the safety, tolerability and best dose of pazopanib to be given to patient with liver cancer.


Eligibility criteria: Inclusion criteria:

* Diagnosis of advanced liver cancer adequate bone marrow, liver and kidney function
* Any local therapy for tumor must have been completed at least 4 weeks prior to enrolling in study

Exclusion criteria:

* Pregnant or breastfeeding
* Any serious or unstable medical or psychiatric conditions
* History of metastases to central nervous system
* History of ulcer, inflammatory bowel disease or disease of the gut
* History of HIV, or uncontrolled infection
* Have had a cardiac condition or stoke during the past 6 months
* High blood pressure
* Have had a blood clot during the past 6 months
* History of bleeding blood vessels

Primary outcomes:
measure: Adverse events (AEs) and changes in vital signs and laboratory values. A dose regimen where no more than 1 out of 6 subjects experience a dose-limiting toxicity (DLT) will define the maximum tolerated dose (MTD).
timeFrame: throughout the study
Secondary outcomes:
measure: Various pharmacokinetic parametersAlpha-fetoprotein (AFP) measurements and scans
timeFrame: throughout the study
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: Hong Kong
country: Hong Kong
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Yau T, Chen PJ, Chan P, Curtis CM, Murphy PS, Suttle AB, Gauvin J, Hodge JP, Dar MM, Poon RT. Phase I dose-finding study of pazopanib in hepatocellular carcinoma: evaluation of early efficacy, pharmacokinetics, and pharmacodynamics. Clin Cancer Res. 2011 Nov 1;17(21):6914-23. doi: 10.1158/1078-0432.CCR-11-0793. Epub 2011 Aug 10.
Clinical trial NCT03902613: 18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder
Official title: 18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Depression
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2019-04-04
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this project is to understand what causes bipolar disorder and how medications treat bipolar depression. Particularly, the project focuses on the importance of dopamine signaling in the process. Participants will have two different brain scans (MRI and PET scan). They will also have treatment for your depression with an FDA approved medication, lurasidone (Latuda). The study is funded by the Columbia University Irving Institute to improve the treatment of bipolar disorder.


Eligibility criteria: Inclusion Criteria:

* Bipolar I disorder, bipolar II disorder or other specified bipolar disorder
* Currently in a major depressive episode and moderately depressed
* Age 18-50 years old
* Patients on psychiatric medications will not be benefitting from those medications
* Females of childbearing potential must be willing to use an acceptable form of birth control throughout the study

Exclusion Criteria:

* Diagnosis of schizophrenia or other psychotic disorders, recent alcohol or substance use disorder, recent anorexia or bulimia nervosa
* Previous failed trial of lurasidone, or had intolerable side effects of lurasidone
* Significant active physical illness
* Actively suicidal
* ECT within the past 6 months
* Recent pregnancy, abortion or miscarriage or plans to conceive during the study; currently lactating
* Metal in the body that is not MRI compatible
* Current, past or anticipated exposure to radiation
* Currently taking an anticoagulant medication

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Martin Lan, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03667313: Treatment of In-Stent Restenosis 2 Study
Official title: Prospective Randomised Study Comparing Efficacy of Treatment Coronary In-stent Restenosis Using Sirolimus-Eluting and Iopromide-Coated Paclitaxel-Eluting Balloon Catheters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Restenosis
Keywords: in-stent restenosis; sirolimus-; paclitaxel-eluting balloon
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 200
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: The aim of this study is to compare the efficacy of sirolimus-eluting balloon catheters (SEB) and iopromide-coated paclutaxel-eluting balloon catheters (PEB) in the treatment of bare metal (BMS) - or drug-eluting stents restenosis (DES-ISR).

Detailed description: Current therapy for in-stent restenosis (ISR) is based on the drug-eluting stents (DES) or drug-eluting balloon catheters (DEB). In clinical practice, paclitaxel is used as an effective antiproliferative agent loaded into DEB (paclitaxel-eluting balloon catheters; PEB).

In contrast to paclitaxel, sirolimus is difficult to deliver on the balloon surface, due to insufficient tissue uptake and shorter tissue retention of limus drugs. It was found that phospholipid-encapsulated sirolimus nanoparticles could be used for coating balloon catheters to provide efficient drug transfer to vessel wall with high tissue concentration.

This prospective randomized non-inferiority study compares the efficacy of new sirolimus-eluting balloon catheters (SEB) and iopromide-coated paclutaxel-eluting balloon catheters (PEB) in the treatment of bare metal (BMS) - or drug-eluting stents restenosis (DES-ISR).

The primary end-point is in-segment late lumen loss (LLL) at 12 months as measured by quantitative coronary angiography (QCA).

Secondary end-points are the incidence of binary ISR (˃50% DS) and the overall incidence of 12-month major adverse cardiac events (MACE; cardiovascular death, non-fatal acute myocardial infarction \[AIM\], or target vessel revascularization \[TVR\]).

Eligibility criteria: Inclusion Criteria:

* patients with BMS- or DES-ISR (˃50% diameter stenosis; DS)
* ≥18 years of age
* willing to sign an Informed consent

Exclusion Criteria:

* concomitant diseases with an expected survival time of less than 12 months
* or that limited the possibility of control coronary aniography (e.g., advanced renal failure).
* impossibility of long-term (6 months) dual antiplatelet treatment

Primary outcomes:
measure: Late lumem loss (LLL)
timeFrame: 12-month
Secondary outcomes:
measure: repeated binary restenosis
timeFrame: 12-month
measure: major adverse cardiac events (MACE)
timeFrame: 12-month
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: Cardiovascular Department of University Hospital
Study officials:
References:
Clinical trial NCT03360513: Determining Shapes and Dimensions of Dental Arches for the Use in Lingual Technique.
Official title: Determining Shapes and Dimensions of Dental Arches for the Use in Lingual Technique.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Arch Relationship Anomaly
Keywords: Orthodontics
Dental arch
Orthodontic appliance design.
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 70
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 70 Caucasian Brazilian individuals (28 men and 42 women) with an average age of 16.4 years

Brief summary: This study aims to determine the shape and dimension of dental arches from a lingual perspective, and determine shape and size used for lingual Orthodontics.

Detailed description: The study sample comprised 70 Caucasian Brazilian individuals with normal occlusion and at least four of Andrew's six keys. Maxillary and mandibular dental casts were digitized (3D) and the images were analyzed by Delcam Power SHAPET 2010 software. Landmarks on the lingual surface of teeth were selected to determine the shape and size of dental arches.

Eligibility criteria: Inclusion Criteria:criterion was that individuals should be at least 15 years of age all permanent teeth in occlusion -

Exclusion Criteria:with no odontogenic abnormalities

-

Primary outcomes:
measure: Statistic study
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Disciplina de Otorrinolaringologia Pediatrica
Study officials:
affiliation: Federal University of São Paulo
name: Shirley SN Pignatari, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lombardo L, Saba L, Scuzzo G, Takemoto K, Oteo L, Palma JC, Siciliani G. A new concept of anatomic lingual arch form. Am J Orthod Dentofacial Orthop. 2010 Sep;138(3):260.e1-260.e13; discussion 260-1. doi: 10.1016/j.ajodo.2010.04.022.
Clinical trial NCT04907513: Amotivational Syndrome and Fatigue in Neurosurgery
Official title: Amotivational Syndrome and Fatigue in Neurosurgery: The Impact of Neuroinflammation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Injury
Motivation
Fatigue
Keywords: cerebrospinal fluid
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2021-05-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients required an external drainage of the cerebrospinal fluid

Brief summary: Depression is a major public concern associated with profound distress, intense suffering, and impairment in social, professional and familial functioning. Among the numerous symptoms defining depression, fatigue and motivation are not only frequent but also highly associated with poor quality of life and resistance to conventional antidepressant. Recent data, mainly obtained in animals, suggest that these symptoms may be linked to inflammatory processes within the central nervous system. Yet access to the brain is too invasive for exploring this link in patients with psychiatric conditions. However, certain conditions in neurosurgery, such as aneurysm rupture, require external evacuation, over several days or weeks, of the fluid bathing the brain through a catheter directly inserted into it. Critically, these patients also exhibit extreme exhaustion and fluctuating motivation, allowing to investigate the involvement of neuroinflammation in lack of motivation and fatigue by carrying out repeated motivation assessments with short behavioral tests (around ten minutes), while performing an analysis of inflammation markers in the fluid evacuated from the brain. The identification of inflammatory mechanisms underlying lack of motivation and fatigue could lead to the development of treatments for both resistant depression and motivation deficits that largely hamper rehabilitation in neurosurgery.


Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years old
* Patients required an external cerebrospinal fluid drainage

Exclusion Criteria:

* Pregnant or breast feeding patient
* Patient under legal protection
* Patient opposition to participate in this study

Primary outcomes:
measure: Nerotransmitter levels in cerebrospinal fuid in relation to patient motivational condition
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation Adolphe de Rothschild
state: Ile-de-France
Study officials:
References:
Clinical trial NCT00006313: Hormone Therapy Effects on CVD Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Coronary Disease
Heart Diseases
Postmenopause
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-09-29
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief summary: To conduct extended analysis of the Postmenopausal Estrogen/Progestins Intervention PEPI trial database to address questions related to cardiovascular disease risk factor response and the possible determinants of this response.

Detailed description: BACKGROUND:

Cardiovascular disease is the leading cause of death among postmenopausal women. Growing evidence exists that hormone replacement therapy (HRT) may reduce cardiovascular disease and mortality. This has led to the use of postmenopausal HRT for primary prevention of heart disease, however it remains unresolved which women are likely to benefit most from this clinical approach. This is a complicated question because many potential mechanisms are involved by which hormone therapy (HRT) may confer cardioprotection. The Postmenopausal Estrogen/Progestins Intervention (PEPI) trial examined the relative impact of four regimens of hormone therapy on a range of cardiovascular disease risk factors (e.g. lipids, blood pressure, insulin/glucose, hemostasis factors). The trial was well conducted; its data have been thoroughly edited and have yielded a series of important publications. To date, however, publications have focused on average effects without a thorough exploration of the range of, and interplay among, the various effects across the 875 enrolled in the trial.

DESIGN NARRATIVE:

The study extended the analysis of PEPI data by: 1) characterizing the distributions of responses to hormone therapy with respect to risk factors for cardiovascular disease (lipids/lipoproteins, blood pressure, insulin/glucose, hemostasis factors); 2) examining the multivariate patterns of treatment effects among these cardiovascular risk factors and on other outcomes (symptomatology, bone, endometrial); 3) examining clinical and demographic factors that may affect these relationships and, in doing so, characterizing women who may vary with respect to their "sensitivity" to the separate effects of estrogen and progestin therapy; 4) examining closely patterns of adherence and their relationship to response. An experienced team of statisticians/epidemiologists conducted and planned to publish results from these analyses.

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:
Clinical trial NCT02594813: Bleeding Rate After EGD and Colonoscopy in Patients Who Continue to Take Antithrombotic Agents
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bleeding After GI Endoscopy
Lead sponsor: Showa Inan General Hospital
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 10000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who continue to take antithrombotic drugs undergo EGD including biopsy and colonoscopy including biopsy, snare or hot polypectomy and/or EMR.

Brief summary: The bleeding rate of both EGD (including biopsy) and colonoscopy (including biopsy, cold or hot snare polypectomy, or EMR) in patients who continue to take various antithrombotic drugs is studied prospectively. The immediate or delayed bleeding that requires hemostatic clipping or other endoscopic treatments is defined as the bleeding. Immediate bleeding requiring hemostatic clipping is defined as spurting or oozing which continued for more than 30 seconds. Delayed bleeding is defined as bleeding that requires the endoscopic treatment within 2 weeks after endoscopy. Prophylactic clipping is not performed after taking biopsy and doing polypectomy. Additionally, investigators evaluate the rate of injured submucosal arteries of the excised specimen when the bleeding occurs.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria is all patients who continue to take antithrombotic drugs and undergo EGD or colonoscopy

Exclusion Criteria:

* Patients who take prophylactic clipping after biopsy or polypectomy American Society of Anesthesiologists physical status of class IV or V

Primary outcomes:
measure: the rate of delayed bleeding
timeFrame: 10 years
Secondary outcomes:
measure: the rate of immediate bleeding
timeFrame: 10 years
measure: the number of clip used
timeFrame: 10 years
Other outcomes:
Locations:
city: Komagane
country: Japan
facility: Showa Inan General Hospital
Study officials:
affiliation: Showa Inan General Hospital
name: Akira Horiuchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morita A, Horiuchi I, Tanaka N, Takada H, Graham DY, Horiuchi A. Managing bleeding risk after cold snare polypectomy in patients receiving direct-acting oral anticoagulants. Gastrointest Endosc. 2022 May;95(5):969-974. doi: 10.1016/j.gie.2022.01.005. Epub 2022 Jan 19.
Clinical trial NCT06575413: Investigating the Role and Electrophysiological Characteristics of the Human Claustrum Based on SEEG
Official title: Investigating the Role and Electrophysiological Characteristics of the Human Claustrum Based on SEEG
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Refractory Epilepsy
Consciousness, Loss of
Keywords: Refractory Epilepsy
Consciousness
Claustrum
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 10
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This single-center prospective study aims to investigate the electrophysiological characteristics and functions of the human claustrum by analyzing clinical, imaging, and electrophysiological data from 14\~65-year-old patients with drug-resistant epilepsy.

Detailed description: Stereoelectroencephalography (SEEG) is a method for recording electrical activity from deep brain structures using implanted depth electrodes to provide a three-dimensional view of neuronal activity.

Direct Electrical Stimulation (DES) is a neurosurgical technique that involves delivering electrical impulses to specific brain regions through implanted electrodes to map critical functional areas and to study the connectivity of brain regions.

This study aims to investigate the electrophysiological characteristics and functions of the human claustrum by analyzing clinical, imaging, and electrophysiological data from patients aged 14 to 65 implanted intracranial electrodes , with a specific focus on electrodes targeting the claustrum. This research forms part of a broader initiative to explore the functions of cortical and subcortical regions based on SEEG.

Eligibility criteria: Inclusion Criteria:

1. The patients were diagnosed with drug-resistant epilepsy.
2. The patients underwent stereoelectroencephalography (SEEG) implantation for pre-surgical evaluation of epilepsy, with at least one electrode target reaching the claustrum
3. Participants/parents/legal guardian provide informed consent for inclusion

Exclusion Criteria:

1. Subjects that experience surgical complications during the implant procedure will be excluded from the study

Primary outcomes:
measure: Patients Clinical responses Rating
timeFrame: During the trial(up to 3 hours for each subject)
measure: EEG power in spectral frequency bands
timeFrame: During the trial(up to 3 hours for each subject)
measure: The root mean square (RMS) value of Claustrum-Cortical Evoked Potentials
timeFrame: During the trial(up to 3 hours for each subject)
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital,Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Liankun Ren
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00490113: A Trial of Pyridoxamine to Lower Urine Oxalate in Subjects With Stone Disease or Hyperoxaluria
Official title: Effects of Pyridoxamine on Oxalate Excretion in Stone Disease and Hyperoxaluria
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Kidney Stones
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2007-06-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine whether pyridoxamine can decrease oxalate excretion in subjects who have normal oxalate excretion (but who have had kidney stones), and in subjects who have primary hyperoxaluria.


Eligibility criteria: Inclusion Criteria:

* Adults \> 18 years
* History of stone formation
* Good Renal function
* Normal urinary excretion of stone-promoting chemicals(Ca, uric acid, oxalate, citrate), except for subjects with hyperoxaluria for Study

Exclusion Criteria:

* Pregnancy
* Hyperparathyroidism
* Enteric hyperoxaluria.
* Obstructive uropathy
* Infection (struvite) stones
* Severe dietary Ca++ restriction or deficiency
* Recent significant cardio-vascular events

Primary outcomes:
measure: Urinary Excretion of Oxalate at Highest Dose
timeFrame: 4 Weeks
Secondary outcomes:
measure: Change in Urinary Supersaturation
timeFrame: 4 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Kansas Medical Center
name: Jon I Scheinman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: