louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00659724: Ease of Use and Blood Clotting for the Gambro Polyflux HD-C4 Big Dialyzer
Official title: The Gambro Polyflux HD-C4 Big Ease Of Use And Thrombogenicity Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Failure
Keywords: Dialyzer
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Advanced Dialysis Center of Potomac
name: Advanced Dialysis Center of Easton
name: Gambro Renal Products, Inc.
name: Baxter Healthcare Corporation
First posted: 2008-04-16
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Assessment of dialyzer ease of use and thrombogenicity assessments following routine dialysis therapy of 33 adult patients (18 years of age or older)

Brief summary: The purpose of this study is to collect information on the ease of use and thrombogenicity of the Polyflux HD-C4 Big and Fresenius Optiflux 180NR or 200NR dialyzers under conditions of routine clinical use for hemodialysis.

Detailed description: This ease of use study involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy. This study is aimed at obtaining feedback from the nursing and technical staff regarding the use and thrombogenicity of the Polyflux HD-C4 Big, and Fresenius Optiflux 180NR or 200NR dialyzers. The dialysis nursing staff will complete ease of use and thrombogenicity assessments following routine dialysis therapy. Any adverse events will be tracked for the study patients.

Eligibility criteria: Inclusion Criteria:

* Hemodialysis patients 18 years of age or older

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Ease of Use: Priming Blood Side
timeFrame: Priming at each treatment
measure: Ease of Use: Priming Dialysate Side
timeFrame: Priming at each treatment
measure: Dialyzer Assessment: Fiber Condition
timeFrame: Each treatment: assessment of the condition of the dialyzer fibers after rinse-back
measure: Dialyzer Assessment: Arterial Header Condition
timeFrame: Each treatment: assessment of the condition of the arterial header after rinse-back
measure: Dialyzer Assessment: Venous Header Condition
timeFrame: Each treatment: the assessment of the condition of the venous header after rinse-back
Secondary outcomes:
Other outcomes:
Locations:
city: Easton
country: United States
facility: Advanced Dialysis Center of Easton
state: Maryland
city: Arlington
country: United States
facility: Advanced Dialysis Center of Potomac
state: Virginia
Study officials:
References:
Clinical trial NCT00766324: PHA-739358 for Treatment of Hormone Refractory Prostate Cancer
Official title: A Phase II Study of PHA-739358 in Patients With Metastatic Hormone Refractory Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Hormone Refractory Prostate Cancer
Lead sponsor: Nerviano Medical Sciences
Sponsor class: INDUSTRY
First posted: 2008-10-03
Enrollment: 118
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the antitumor activity of PHA-739358 administered as IV infusion according to two different dose schedules in metastatic HRPC patients progressing on standard, docetaxel-based 1st-line chemotherapy for HRPC based on PSA response, and to select the best dose schedule for further investigation.


Eligibility criteria: Inclusion Criteria:

* Metastatic hormone refractory prostate cancer progressing after docetaxel based therapy
* Adequate bone marrow, liver and kidney function

Exclusion Criteria:

* More than one prior chemotherapy line
* Uncontrolled hypertension
* Brain or leptomeningeal disease
* Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident in the previous 6 months

Primary outcomes:
measure: PSA response rate defined according to the recommendations from the Prostate-Specific Antigen Working Group
timeFrame: within the first three months of treatment
Secondary outcomes:
measure: Objective Response Rate, Progression Free Survival, additional PSA based endpoints, clinical benefit
timeFrame: all cycles
measure: Overall safety profile
timeFrame: all cycles
Other outcomes:
Locations:
city: Nerviano
country: Italy
facility: Nerviano Medical Sciences. Clinical Research Dept.
state: Milano
Study officials:
References:
Clinical trial NCT02156024: The Short-term Efficacy of Gastrodia and Uncaria Drink in Treating Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Masked Hypertension
Keywords: clinical trials
Gastrodia and Uncaria Drink
Lead sponsor: Shanghai Institute of Hypertension
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is

1. To determine whether the Gastrodia and Uncaria Drink is effective in the treatment of masked hypertensive patients below 70 years.
2. To find out the suitable groups for the Gastrodia and Uncaria Drink treatment.


Eligibility criteria: Inclusion Criteria:

* age between 18 to 70 years
* didn't use any anti-hypertension drugs within 2 weeks
* stage 1 masked hypertensive patients, which means clinic blood pressure\<140/90 mmHg,however the daytime(8:00-18:00) 24h ambulatory blood pressure between 135/85 and 150/95mmHg
* be willing to participate in the trials and able to finish clinic visit

Exclusion Criteria:

* secondary hypertension
* be allergic to the clinical trial medicine
* occurrence of stroke, CKD, myocardial infarction within 2 years
* dysfunction of liver or kidney and fundus hemorrhage
* arrhythmia
* ALT, AST, TBL upper the twice of normal range, Scr≥2.0mg/dl, K+≥5.5mmol/L, Urine protein≥2+
* psychiatric disorders
* pregnant, breastfeeding
* other serious conditions in which is not fit for the study

Primary outcomes:
measure: blood pressure
timeFrame: March 1,2015
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
References:
citation: Zhang DY, Cheng YB, Guo QH, Shan XL, Wei FF, Lu F, Sheng CS, Huang QF, Yang CH, Li Y, Wang JG. Treatment of Masked Hypertension with a Chinese Herbal Formula: A Randomized, Placebo-Controlled Trial. Circulation. 2020 Nov 10;142(19):1821-1830. doi: 10.1161/CIRCULATIONAHA.120.046685. Epub 2020 Oct 6.
citation: Wei FF, Li Y, Zhang L, Shan XL, Cheng YB, Wang JG, Yang CH, Staessen JA. Persistence of Masked Hypertension in Chinese Patients. Am J Hypertens. 2016 Mar;29(3):326-31. doi: 10.1093/ajh/hpv106. Epub 2015 Jul 6.
Clinical trial NCT00550524: Stem Cell Transplantation for the Treatment of Knee Osteoarthritis
Official title: Phase 1 Study of Bone Marrow - Derived Stem Cell for the Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Knee Osteoarthritis
Keywords: Knee osteoarthritis
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-10-30
Enrollment: 5
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find if autologous stem cell transplantation can improve clinical manifestations of knee osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Moderate bilateral knee osteoarthritis

Exclusion Criteria:

* No infectious or inflammatory arthritis

Primary outcomes:
measure: 1- Comparison of pain in the injected knee with the controlateral knee 2- Comparison of joint motion of the injected knee with the controlateral knee
timeFrame: 12 months
Secondary outcomes:
measure: Evaluation of side-effects
timeFrame: 12 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital)
Study officials:
affiliation: Rheumatology Research Center, Medical Sciences/University of Teheran
name: Fereydoun Davatchi, MD
role: STUDY_CHAIR
affiliation: Department of Immunology, Medical Sciences/University of Tehran
name: Behrouz Nikbin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Le Blanc K. [Mesenchymal stem cells. Basic science and future clinical use]. Lakartidningen. 2002 Mar 21;99(12):1318-21, 1324. Swedish.
citation: Caplan AI. Mesenchymal stem cells. J Orthop Res. 1991 Sep;9(5):641-50. doi: 10.1002/jor.1100090504.
citation: Caplan AI, Elyaderani M, Mochizuki Y, Wakitani S, Goldberg VM. Principles of cartilage repair and regeneration. Clin Orthop Relat Res. 1997 Sep;(342):254-69.
citation: Solchaga LA, Welter JF, Lennon DP, Caplan AI. Generation of pluripotent stem cells and their differentiation to the chondrocytic phenotype. Methods Mol Med. 2004;100:53-68. doi: 10.1385/1-59259-810-2:053.
citation: Caplan AI. Adult mesenchymal stem cells for tissue engineering versus regenerative medicine. J Cell Physiol. 2007 Nov;213(2):341-7. doi: 10.1002/jcp.21200.
citation: Davatchi F, Abdollahi BS, Mohyeddin M, Shahram F, Nikbin B. Mesenchymal stem cell therapy for knee osteoarthritis. Preliminary report of four patients. Int J Rheum Dis. 2011 May;14(2):211-5. doi: 10.1111/j.1756-185X.2011.01599.x. Epub 2011 Mar 4.
Clinical trial NCT01537224: Electrophysiological Activity of the Subthalamic Nucleus During the Processing of Emotional and Motivational Information
Official title: Study of the Electrophysiological Activity of the Subthalamic Nucleus During the Processing of Emotional and Motivational Information in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson
Keywords: Electrophysiology
Subthalamic nucleus
Parkinson
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 25
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: The role of the basal ganglia in the processing of information with emotional or motivational content has been demonstrated by several lesion and functional imaging studies in humans and animals. Deep brain stimulation surgery provides an opportunity to study these structures in humans in electrophysiological terms. The aim of this study is to investigate modifications in the electrophysiological activity of the subthalamic nucleus (STN) during the perception of auditory and visual stimuli with emotional or motivational connotations in patients with Parkinson's disease who have just undergone implantation of a deep brain stimulator in the STN.


Eligibility criteria: Inclusion Criteria:

* Patient with Parkinson's disease selected for deep brain stimulation (DBS) of the subthalamic nucleus (STN) in accordance with the criteria established by Welter and colleagues (Welter et al., 2002);
* Aged 18 years or above;
* Written informed consent from the patient.

Exclusion Criteria:

* Patient under a legal incapacity or with limited legal capacity;
* Patient who has perioperative complications or postoperative confusion;
* Patient displaying cognitive disturbances involving the early stages of speech processing (on the basis of an audiogram systematically conducted prior to surgery) ;
* Patient displaying cognitive disturbances involving the early stages of face processing (on the basis of the Benton Facial Recognition Test (Benton, Hamsher, Varney, \& Spreen, 1983) systematically administered prior to surgery);
* Patient incapable of understanding the information given about the study, performing the tasks or providing informed consent.

Primary outcomes:
measure: Electrophysiological activity of the subthalamic nucleus
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: Rennes University Hospital
name: Marc Verin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00373724: A Placebo-Controlled Study Assessing Lateral Branch Radiofrequency Denervation for Sacroiliac (SI) Joint Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: sacroiliac joint
low back pain
radiofrequency
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2006-09-08
Enrollment: 30
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: In order to determine whether L4 and L5 primary dorsal rami and S1-3 lateral branch radiofrequency denervation is effective for sacroiliac (SI) joint pain, we are conducting a randomized, controlled study.

Detailed description: 30 subjects with SI joint pain confirmed by SI joint injections will be randomized to receive either L4 and L5 primary dorsal rami and S1-3 lateral branch radiofrequency denervation or sham denervation. To facilitate patient blinding, in both groups 1 ml of lidocaine will be injected before true (or sham) denervation so patients cannot feel heating. The stimulation will be the same for both groups and blinding assessed after the procedure. Follow-up visits will be at 1,3 and 6-months postprocedure.

Eligibility criteria: Inclusion Criteria:

* Sacroiliac joint pain
* Age \> 18

Exclusion Criteria:

* No focal neurological signs or symptoms, coagulopathy, unstable medical or psychiatric condition

Primary outcomes:
measure: visual analogue scale pain score, Oswestry Disability Index
timeFrame: 1, 3 and 6 months postprocedure
Secondary outcomes:
measure: Medication reduction, global perceived effect, work status
Other outcomes:
Locations:
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Steven P Cohen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins School of Medicine
name: Srinivasa N Raja, MD
role: STUDY_DIRECTOR
References:
citation: Cohen SP, Abdi S. Lateral branch blocks as a treatment for sacroiliac joint pain: A pilot study. Reg Anesth Pain Med. 2003 Mar-Apr;28(2):113-9. doi: 10.1053/rapm.2003.50029.
citation: Yin W, Willard F, Carreiro J, Dreyfuss P. Sensory stimulation-guided sacroiliac joint radiofrequency neurotomy: technique based on neuroanatomy of the dorsal sacral plexus. Spine (Phila Pa 1976). 2003 Oct 15;28(20):2419-25. doi: 10.1097/01.BRS.0000085360.03758.C3.
citation: Cohen SP. Sacroiliac joint pain: a comprehensive review of anatomy, diagnosis, and treatment. Anesth Analg. 2005 Nov;101(5):1440-1453. doi: 10.1213/01.ANE.0000180831.60169.EA.
citation: Cohen SP, Hurley RW, Buckenmaier CC 3rd, Kurihara C, Morlando B, Dragovich A. Randomized placebo-controlled study evaluating lateral branch radiofrequency denervation for sacroiliac joint pain. Anesthesiology. 2008 Aug;109(2):279-88. doi: 10.1097/ALN.0b013e31817f4c7c.
Clinical trial NCT00657124: Effect of Preoperative Supplementation in Insulin Resistance
Official title: Preoperative Oral Supplementation of Carbohydrate and Branched-Chain Amino Acids-Enriched Nutrient Improves Insulin Resistance in Patients With Hepatectomy; Prospective Randomized Clinical Trial by Using Artificial Pancreas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Disease
Keywords: AEN
Lead sponsor: Kochi University
Sponsor class: OTHER
First posted: 2008-04-14
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To elucidate the effect of preoperative supplementation of carbohydrate and branched-chain amino acids on postoperative insulin resistance in patients undergoing hepatic resection, we set a randomized trial.

Detailed description: Twenty-six patients with hepatectomy due to a live tumor were prospectively randomized to receive a preoperative supplementation with carbohydrate and branched-chain amino acids-enriched nutrient or not.

Eligibility criteria: Inclusion Criteria:

* The present study employed 26 patients, who underwent elective liver resection for hepatocellular carcinoma or adenocarcinoma.

Exclusion Criteria:

* body weight loss greater than 10 per cent during 6 months prior to the surgery
* distant metastasis
* or seriously impaired function of vital organs due to respiratory, renal or heart disease

Primary outcomes:
measure: to evaluate the total amount of insulin required for glycemic control after hepatic resection
timeFrame: total amount of insulin required
Secondary outcomes:
measure: to investigate the trends of postoperative blood glucose levels and the incidence of severe hypoglycemia (< 40 mg/dL) by using artificial pancreas during intensive care unit stay
timeFrame: hypoglycemia
Other outcomes:
Locations:
city: Nankoku-City
country: Japan
facility: Kochi Medical School
state: Kohasu-Okocho
Study officials:
affiliation: Kochi Medical School, Kochi University
name: Takehiro Okabayashi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00788424: Topical Application of AS101 for the Treatment of Psoriasis
Official title: Study of Topical Application of AS101 for the Treatment of Psoriasis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Mild to Moderate Psoriasis
Keywords: AS101 Psoriasis
Lead sponsor: BioMAS Ltd
Sponsor class: INDUSTRY
First posted: 2008-11-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This protocol relates to a phase II randomized double blind, placebo controlled study of the AS101 topical application for the treatment of mild to moderate Psoriasis.


Eligibility criteria: Inclusion Criteria:

1. Patient have a diagnosed mild to moderate stable plaque type psoriasis (less than 10% of body skin surface).
2. Patient must be 18-70 years of age.
3. General health must be adequate to allow for compliance with the requirements of this protocol.
4. Patient or his/her legal guardian must sign an informed consent form prior to study participation.
5. Patient must be able and willing to comply with all protocol requirements.

Exclusion Criteria:

1. Patients who are mentally disabled or are otherwise unable to provide fully informed consent.
2. Pregnant or breast-feeding females.
3. Patients with evidence of an infection in the targeted zones.
4. Patients with known sensitivity to any of the drug components.
5. Patients treated by systemic anti psoriatic medications within one month prior to the initial treatment with the AS101, or topical anti psoriatic preparations within two weeks prior to the initial treatment with the AS101.
6. Patient with psoriatic arthritis.
7. Patients taking immunosuppressive drugs.
8. Immunocompromised patients

Primary outcomes:
measure: To evaluate the percentege of patients in which modified PASI (mPASI) score reduction of more than 66% from Baseline whithin 12-week treatment period is achieved
timeFrame: 12 weeks treatment and 3 month follow up
Secondary outcomes:
measure: The main secondary endpoints are to evaluate safety, tolerability of topical AS010 treatment and long term remission of psoriasis.
timeFrame: 12 weeks treatment and 3 month follow up
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Arie Ingbar, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05962424: HNC: Human Neural Circuits Electrophysiology During Cognition
Official title: HNC: Human Neural Circuits Electrophysiology During Cognition
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Psychiatric Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 120
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: The purpose of this study is to understand how ketamine brings about dissociative symptoms.

Detailed description: The goal of this proposed research is to record the effects of ketamine on brain activity to understand the changes that occur during antidepressant therapy and the side effect of dissociation. This research is designed to probe altered cognitive states associated with dissociation, depression, and other neuropsychiatric conditions.

Eligibility criteria: Inclusion Criteria:

* Patient in clinical neuro inpatient units at Stanford Medical Center
* Age \>18 years old
* Female participants are expected to use an effective method of birth control throughout the study which includes: hormonal methods (birth control pills, patches, injections, vaginal ring or implants), barrier methods (condom or diaphragm) used with spermicide, intrauterine device (IUD), or abstinence (no sex)

Exclusion Criteria:

* Lifetime psychotic disorder
* Pregnant or nursing females
* Prior adverse ketamine response
* Use of ketamine in past 7 days

Primary outcomes:
measure: Number of participants with dissociative events during ketamine infusion as assessed by CADSS (Clinician-Administered Dissociative State Scale)
timeFrame: up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Karl Deisseroth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: