louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03868397: Preoperative Portal and Splanchnic Flow Measurement Using MRI
Official title: Preoperative Portal and Splanchnic Flow Measurement in Living Donor Liver Transplantation Recipient With Spontaneous Portosystemic Shunt at MRI: Preliminary Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhoses
Keywords: MRI
cirrhosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
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 assess the alteration of portal and splanchnic flow using MRI after liver transplantation in patients with splenomegaly or splenic varix.


Eligibility criteria: Inclusion Criteria:

* older than 18 years
* And signed informed consent
* And planned either a) liver transplantation as a recipient; or b) liver transplantation as a donor

Exclusion Criteria:

* any absolute/relative contraindication of contrast-enhanced MRI

Primary outcomes:
measure: Portal flow
timeFrame: in a month after 2nd MRI
Secondary outcomes:
measure: SMV flow
timeFrame: in a month after 2nd MRI
measure: Splenic vein flow
timeFrame: in a month after 2nd MRI
measure: splenic varix flow
timeFrame: in a month after 2nd MRI
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Hee Yoon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00038597: Phase II Study of SCH66336, A Farnesyltransferase Inhibitor in Chronic Myelogenous Leukemia (CML)
Official title: Phase II Study of SCH66336, A Farnesyltransferase Inhibitor in Chronic Myelogenous Leukemia (CML)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myelogenous Leukemia, Chronic
Keywords: Philadelphia chromosome positive CML
Myelogenous Leukemia, Chronic, Chronic Phase
Myelogenous Leukemia, Chronic, Accelerated Phase
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2002-06-04
Enrollment: 13
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this research is to see if giving the drug SCH66336 by mouth can improve the disease in patients with chronic or accelerated phase CML. The safety of this treatment will also be studied.

Detailed description: Objectives for this study are two-fold:

1. To determine the efficacy of SCH66336 in patients with chronic phase and accelerated phase CML in relation to response rate, duration of response, and survival.
2. To assess the toxicity of SCH66366 in these patients.

Eligibility criteria: * Diagnosis of Philadelphia chromosome (Ph) -positive CML in chronic or accelerated phase;
* Failure to respond to or intolerance to imatinib mesylate (Gleevec);
* Age \>/= 16 years;
* Life expectancy of \>/= 2 months;
* Performance status 2 or better (Zubrod);
* Adequate renal and hepatic functions (creatinine and bilirubin \</= 2 mg/dl);
* Adequate cardiac function;
* Not candidates for or have refused allogeneic transplantation;
* Patients should not be receiving azoles (ketoconazole, itraconazole, fluconazole), macrolides, HIV protease inhibitors, cyclosporin or anti-seizure drugs (phenobarbital, phenytoin, carbamazepine), rifampin or isoniazid.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MDAnderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Jorge Cortes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03657797: Phase 2 Dose-Response Study Evaluating the Safety and Efficacy of NCX 470 vs Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Official title: A Phase 2, Randomized, Multicenter, Masked, Parrallel-Group, Dose-Response Study Evaluating the Safety and Efficacy of NCX 470 (3 Doses: 0.021%, 0.042%, and 0.065%) vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma, Open-Angle
Hypertension, Ocular
Lead sponsor: Nicox Ophthalmics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-05
Enrollment: 656
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this clinical study is to evaluate the safety and efficacy of NCX 470 ophthalmic solution in lowering intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. Three different concentrations of NCX 470 ophthalmic solution (0.021%, 0.042%, and 0.065%) will be compared to latanoprost 0.005% ophthalmic solution.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
* Qualifying IOP at 3 time points throughout the day at 2 visits following washout of IOP-lowering medication, if applicable
* Qualifying best-corrected visual acuity (BCVA) using the Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol in each eye
* Ability to provide informed consent and follow study instructions

Exclusion Criteria:

* Pigmentary or pseudoexfoliative glaucoma
* Narrow anterior chamber angles or disqualifying corneal thickness in either eye
* Clinically significant ocular disease in either eye
* Previous complicated surgery or certain types of glaucoma surgery in either eye
* Incisional ocular surgery or severe trauma in either eye within the past 6 months
* Uncontrolled systemic disease

Primary outcomes:
measure: Change From Baseline in Study Eye Mean Diurnal IOP at the Week 4
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Change From Baseline in Study Eye Mean Diurnal IOP at Week 1, Week 2, and Exit Visit
timeFrame: Baseline, week 1, week 2, exit visit
measure: Percentage of Subjects With Treatment-emergent Ocular Adverse Events
timeFrame: 4 weeks for adverse events and through 30 days post-treatment for serious adverse events
Other outcomes:
Locations:
city: Austin
country: United States
facility: Texan Eye
state: Texas
Study officials:
affiliation: Nicox Ophthalmics, Inc.
name: Nicox Ophthalmics, Inc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06212297: Fellow-eye Study (FE) of LX101 in Subjects With Inherited Retinal Dystrophy
Official title: A Clinical Trial to Evaluate the Safety and Efficacy of Subretinal Re-Administration of LX101 to the Contralateral Eye in Subjects With Biallelic RPE65 Mutation-associated Inherited Retinal Dystrophy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Inherited Retinal Dystrophy
Keywords: RPE65 Mutations
Lead sponsor: Innostellar Biotherapeutics Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-01-18
Enrollment: 9
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Up to nine subjects who have participated in the earlier LX101 clinical study, and who meet all study eligibility criteria, will receive LX101 administration in the previously uninjected, contralateral eye to evaluate the safety of bilateral, sequential subretinal administration of LX101.


Eligibility criteria: Inclusion Criteria:

Prior subretinal administration of LX101 (unilateral)

≥ 6 years old Signed written informed consent

Exclusion Criteria:

Prior gene therapy except LX101 Active intraocular or periocular infections Lacking of sufficient surviving retinal cells Prior ocular surgery within six months Retinoid like compounds or precursors were taken within three months Complicating systemic diseases Clinically significant abnormal baseline laboratory values Using of any retinal toxic compounds

Primary outcomes:
measure: Safety: Incidence of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: 6 months
Secondary outcomes:
measure: Full-field Light Sensitivity Threshold (FST) Test
timeFrame: 6 months、12 months
measure: Visual Acuity
timeFrame: 6 months、12 months
measure: Mobility Test
timeFrame: 6 months、12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT05767697: Genomics and Prognosis in GI Cancers
Official title: Explore the Correlation of Genomics and Prognosis in Alimentary Tract Cancers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: GI Cancer
Liver Cancer
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
Collaborators: name: National Cheng-Kung University Hospital
First posted: 2023-03-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Histology proved pancreatic cancer, esophageal cancer, gastric cancer, hepatocellular carcinoma, cholangiocarcinoma, colorectal cancer

Brief summary: This study aims to collect biospecimens and explore the correlation of genomics and prognosis in alimentary tract cancers.

Detailed description: In this study, the investigators will collect clinical specimens of alimentary tract cancers and perform DNA and RNA analysis to identify genetic alterations for the development of a comprehensive somatic mutation databases and investigate their potential correlation with clinical, radiological and pathological variables. The genomics study included but not limited to target gene panel sequencing, whole exome sequencing, whole genome sequencing, bulk RNA sequencing, single cell RNA sequencing and metagenomics.

Eligibility criteria: Inclusion Criteria:

* Able to sign the informed consent
* Age \>= 20
* Histology proved pancreatic cancer, esophageal cancer, gastric cancer, hepatocellular carcinoma, cholangiocarcinoma, colorectal cancer
* Agree to provide tumor/normal tissue including but not limited to surgical specimen, biopsy, cytology specimen, bile, urine or stool
* Agree to receive blood sampling 20ml at first time and 10ml during each follow-up (total sampling amount no more than 30ml per month)

Exclusion Criteria:

* Cannot cooperate with blood sampling

Primary outcomes:
measure: Number of subjects who still survive at 1 year
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
city: Tainan
country: Taiwan
facility: National Institute of Cancer Research
Study officials:
affiliation: National Health Research Institutes, Taiwan
name: Li-Tzong Chen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03149497: Anterior Only Surgery for Management of Traumatic Subaxial Cervical Spine Instability
Official title: Anterior Only Surgery for Management of Traumatic Subaxial Cervical Spine Instability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Cervical Spine Instability
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Classic management of cervical spine sublaxation and dislocation is combined anterior and posterior approach. Unfortunately there are disadvantages for this approach like: increasing morbidity related to each approach, increasing surgical costs, increasing operative time as well as the risk of blood loss.

Anterior approach has the advantages of supine position, less surgical trauma and direct anterior decompression of neural elements. Disadvantages include less mechanical stability and postoperative dysphagia.


Eligibility criteria: Inclusion Criteria:

* Acute traumatic cases of adult patients with sub axial cervical spine injury presenting to trauma unit of Assiut university hospital

Exclusion Criteria:

* Patients who need cervical corpectomy.
* Pediatric injuries

Primary outcomes:
measure: Radiological analysis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT05347797: Clinical Study Testing DNA Extracted From Tumour Tissue Biopsy Samples, Using the Therascreen® KRAS RGQ PCR Kit
Official title: Phase 3 Multicentre, Prospective, Interventional Clinical Study Testing DNA Extracted From Tumour Tissue Biopsy Samples, Using the Therascreen® KRAS RGQ PCR Kit, From Patients With Non-Small Cell Lung Cancer, Screened in Clinical Study (Protocol No. 20190009).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-small Cell Lung Cancer
Lead sponsor: QIAGEN Gaithersburg, Inc
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2022-04-26
Enrollment: 495
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: An interventional, prospective study. It is estimated that up to 800 patient tissue samples (from approximately 650 patients enrolled at approximately 300 clinical trial sites), will be obtained as part of enrolment into Phase 3 of Clinical Study (Protocol No. 20190009), for testing using the therascreen® KRAS RGQ PCR Kit (KRAS Kit).

Detailed description: This is an interventional, prospective clinical performance study protocol, for the testing of DNA extracted from tumour tissue biopsy samples (resected and core needle biopsy \[CNB\]/fine needle aspiration \[FNA\]) tumour tissue ) obtained from patients with Non-Small Cell Lung Cancer (NSCLC), using the KRAS Kit.

Up to 800 patient tissue samples (from approximately 300 clinical trial sites), obtained in the Clinical Study (Protocol No. 20190009), will be tested using the KRAS Kit. The testing will be performed at the investigational device clinical testing sites, Q2 Solutions Laboratories in the four geographical locations: USA, Singapore, UK and China.

The primary objective of the Clinical Study (Protocol No. 20190009) is to evaluate tumour objective response rate (ORR) assessed by MODIFIED RECIST 1.1 criteria of AMG 510 as a monotherapy in patients using the Clinical Study Assay, KRAS Kit to assess whether to treat patients with KRAS G12Cmutated advanced tumours (NSCLC).

The clinical data from the study will be used to determine the drug-device efficacy to support future regulatory submissions for the device-drug combination.

Eligibility criteria: Inclusion Criteria:

* All patients who provided consent (by signing and dating the ICF for Protocol No. 20190009), may be included in the Clinical Performance Study.

Exclusion Criteria:

* Patients whose tumour tissue biopsy samples are not Clinical Study Assay evaluable will be asked to provide further tumour tissue biopsy samples. Patients with samples identified for the study which have insufficient testing material will have their sample excluded, as will specimens which have undergone decalcification.

Primary outcomes:
measure: therascreen® KRAS RGQ PCR Kit (KRAS Kit).
timeFrame: 5 business days
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: QIAGEN Gaithersburg, Inc
Study officials:
References:
Clinical trial NCT00796497: Ondansetron in Treatment Resistant Obsessive Compulsive Disorder (OCD)
Official title: Ondansetron Augmentation in Treatment Resistant Obsessive Compulsive Disorder: A Preliminary Single-Blind Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obsessive Compulsive Disorder
Keywords: Obsessive Compulsive Disorder
5-ht3
ondansetron
Lead sponsor: Institute of Neuroscience, Florence, Italy
Sponsor class: OTHER
First posted: 2008-11-24
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Given that 5-HT3 receptors are indirect inhibitors of cortico-mesolimbic DA release, the 5-HT3 receptor antagonist ondansetron augmentation might potentially have efficacy in the treatment of resistant Obsessive Comulsive Disorder (OCD) patients on combined SRIs and antipsychotics.

Detailed description: METHOD: Fourteen patients with a DSM-IV diagnosis of treatment resistant OCD, under stable treatment with SSRI's and neuroleptic augmentation will enter an 12-week single blind trial of ondansetron initiated at a dose of 0.25 mg twice daily for 6 weeks, that will be titrated to 0.5 mg twice daily for 6 weeks.

Eligibility criteria: Inclusion Criteria:

1. adults aged 18 to 55
2. a Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of ≥ 20 after ≥ 12 weeks of treatment with an established effective dose of an Selective Serotonin Reuptake Inhibitors or clomipramine and after ≥ 10 weeks of augmentation treatment with antipsychotics (risperidone at least 2 mg/day quetiapine at least 150 mg/day; olanzapine at least 5mg/day; haloperidol titrated at least 10 mg/day; aripiprazole at least 10 mg/day)

Exclusion Criteria:

1. a history of alcohol or substance abuse
2. current severe depressive symptoms, bipolar disorder, panic disorder, schizophrenia, or other psychiatric conditions
3. heart disease, arrhythmia, liver problems, including cirrhosis, seizures, glaucoma or serious medical disease
4. hoarding as only Obsessive Compulsive symptom
5. women of childbearing potential not using a medically acceptable contraceptive method.

Primary outcomes:
measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
timeFrame: 6th 12th week
Secondary outcomes:
measure: clinical global impression (CGI)
timeFrame: 6th e 12th
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Institute of Neuroscience
Study officials:
affiliation: Istituto di Neuroscienze
name: Stefano Pallanti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hewlett WA, Schmid SP, Salomon RM. Pilot trial of ondansetron in the treatment of 8 patients with obsessive-compulsive disorder. J Clin Psychiatry. 2003 Sep;64(9):1025-30. doi: 10.4088/jcp.v64n0907.
citation: Pallanti S, Bernardi S, Antonini S, Singh N, Hollander E. Ondansetron augmentation in treatment-resistant obsessive-compulsive disorder: a preliminary, single-blind, prospective study. CNS Drugs. 2009 Dec;23(12):1047-55. doi: 10.2165/11530240-000000000-00000.
Clinical trial NCT03205397: Impact of a Child-Parent Preoperative Accompanying Procedure on the Anxiety of Children Aged 5 to 12 With Scheduled Surgery
Official title: Impact of a Child-Parent Preoperative Accompanying Procedure on the Anxiety of Children Aged 5 to 12 With Scheduled Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In France, during surgery, only 4% of parents are present at induction, most often for children with disabilities with iterative interventions. Some studies have shown that the presence of parents during induction decreases the anxiety of children, while others do not. Their conclusions all advocate preparing parents for this presence in the operating room in an accompanying course.


Eligibility criteria: Inclusion Criteria:

* 5 to 12 year olds requiring scheduled surgery
* scheduled outpatient or weekly hospitalization.
* Anesthesia envisaged by inhalation induction
* Agreement of parents (and child according to age).
* Even parent (s) present at pre-anesthesia and on the day of surgery

Exclusion Criteria:

* Child with previous surgery
* Parent (s) of a child who has already had surgery
* Parent (s) or child unable to follow the whole procedure (autism, blindness ...)

Primary outcomes:
measure: Level of anxiety
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU de Limoges
Study officials:
References:
Clinical trial NCT06217497: The Effect of Foot Massage in Patients Undergoing Hemodialysis
Official title: The Effect of Foot Massage Applied to Patients Undergoing Hemodialysis on Sleep Quality and Fatigue Level:Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse-Patient Relations
Keywords: Foot Massage
Hemodialysis
Nursing
Sleep Quality
Fatigue
Lead sponsor: Harran University
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was conducted in a randomized controlled design.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hemodialysis patients were divided into experimental and control groups. Foot massage was applied to the patients in the experimental group. Foot massage was not applied to the patients in the control group and routine nursing care was provided. Pre-test, mid-test and post-test sleep quality and fatigue level scores of the patients were determined.

Detailed description: An experimental study design was used to conduct this research on 73 hemodialysis patients treated in a hemodialysis unit. The aim of this study is to investigate how foot massage applied to hemodialysis patients affects sleep quality and fatigue level.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria were determined as follows:

  * Having a PSQI score of 5 points and above
  * Receiving HD treatment for at least 6 months
  * Having no neuropathy d) Using no sleeping pills
  * Having no communication problem
  * Having full orientation and no psychiatric problems
  * Having no conditions in the lower extremities and feet that would preclude massaging (no open wounds on the skin, orthopaedic and joint problems, oedema, abscess, infection, thrombophlebitis, deep vein thrombosis, thrombocytopenia, etc.)
  * Having no history of allergy to the oil used for massage.

Exclusion Criteria:

Exclusion criteria were determined as follows:

* Receiving less than 6 months of HD treatment
* Having communication problem
* Suffering from neuropathy
* Having incomplete orientation and any psychiatric problem
* Having a PSQI score below 5
* Having conditions in the lower extremities and feet that would preclude massaging (open wounds on the skin, orthopaedic and joint problems, oedema, abscess, infection, thrombophlebitis, deep vein thrombosis, thrombocytopenia, etc.) and having a history of allergy to the oil used for massage

Primary outcomes:
measure: Piper fatigue scale
timeFrame: Last 2 weeks and last 4 weeks
Secondary outcomes:
measure: Pittsburgh sleep quality index
timeFrame: Last 2 weeks and last 4 weeks
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Harran University
Study officials:
affiliation: Turgut ÖZAL University
name: Seyhan Çıtlık SARITAŞ, PhD
role: PRINCIPAL_INVESTIGATOR
References: