louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01266382: The Effect of AposTherapy on the Level of Pain, Function and Quality of Life in Patients With Neuro-muscular and Neurological Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Spinal Diseases
Ligament Rupture
Lower Extremity Fracture
Neurological Disorders
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Apos Medical and Sports Technology Ltd.
First posted: 2010-12-24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to examine the effect of a new biomechanical device and treatment methodology (AposTherapy) on gait patterns, pain, function and quality of life of patients with musculoskeletal and neurological disorders. Based on previous reports the investigators hypothesis that this therapy will have a positive effect on these measurements.


Eligibility criteria: Inclusion Criteria:

* Primary osteoarthritis
* Lower limb joint replacement
* Lower limbs fractures
* Spinal disorders including LBP w/wo refered symptoms, radiculopathy, spinal stenosis
* ligaments tear
* Meniscal tears

Exclusion Criteria:

* lack of balance (3 falls in the last year)
* incapable to complete a questionnaire •\>age 85

Primary outcomes:
measure: Spatio-temporal Gait parameters
measure: WOMAC
measure: SF-36
Secondary outcomes:
measure: FAOS questionnaire
measure: Oswestry questionnaire
measure: Clinical measurements
Other outcomes:
Locations:
city: Herzliya
country: Israel
facility: AposTherapy center
Study officials:
References:
citation: Segal G, Bar-Ziv Y, Velkes S, Benkovich V, Stanger G, Debbi EM, Debi R, Mor A, Elbaz A. A non-invasive biomechanical device and treatment for patients following total hip arthroplasty: results of a 6-month pilot investigation. J Orthop Surg Res. 2013 May 21;8:13. doi: 10.1186/1749-799X-8-13.
Clinical trial NCT00141882: Memantine in Patients With Chronic Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open-Angle Glaucoma
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 1119
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: Randomized double-masked clinical trial of memantine in patients with glaucoma


Eligibility criteria: Inclusion Criteria:

* Glaucoma damage on examination of visual field and optic disc
* Good visual acuity (with glasses if needed)

Primary outcomes:
measure: Progression of glaucoma
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00178282: Low-Intensity Physical Therapy for Prevention of Pre and Postpartum Urinary Incontinence
Official title: Pilot Study: Low Intensity Physical Therapy for Prevention of Pre and Postpartum Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Watson Pharmaceuticals
First posted: 2005-09-15
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if pelvic exercises can reduce the occurrence of urinary incontinence (involuntary loss of urine) before and after delivery. We would also like to see if performing pelvic exercises before birth has an effect on labor and/or delivery, and if there are any specific characteristics for developing urinary incontinence during pregnancy and after delivery.

Detailed description: The studies investigating physiotherapy for prevention of urinary incontinence during and after pregnancy used intensive pelvic floor muscle training. While physical therapy appears to be effective in preventing urinary incontinence, extensive physical therapy is too costly to be implemented as a preventive measure for the general population. Thus, we want to asses if non-intensive pelvic floor therapy decreases the urinary incidence of incontinence during pregnancy and postpartum. We propose a prospective randomized controlled trial to obtain baseline data on the effect of non-intensive pelvic floor muscle training of urinary incontinence in primigravid women.

Eligibility criteria: Inclusion Criteria:

* Nulliparous, pregnant women, 18 years or older
* Less than 20 weeks gestation
* Able to give consent and who are willing to participate

Exclusion Criteria:

* Multiparous women
* Women presenting after 20 weeks gestation
* History of urinary incontinence
* Mentally impaired women and women who have neurological impairment affecting ability to perform pelvic floor muscle training

Primary outcomes:
measure: Non-intensive physical therapy, 24hr. voiding diary, pad weight, Quality of Life questionnaires
timeFrame: During and 3 months after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Gunhilde Buchsbaum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00652782: Effects of MK7418 on Diuresis and Renal Function in Congestive Heart Failure Patients
Official title: A Randomized, Double-Blind, Placebo Controlled Dose-Ranging Study of The Effects of MK7418, Both as Monotherapy and in Combination With Furosemide, On Diuresis and Renal Function in Patients With Congestive Heart Failure (CHF) And Renal Impairment Treated With Oral Loop Diuretics Who Require Hospitalization For Fluid Overload
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Congestive Heart Failure
Renal Impairment
Lead sponsor: NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-04-04
Enrollment: 160
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: A study to determine the most appropriate dose of MK7418 in heart failure patients presenting with symptoms of volume overload requiring increased diuretic doses.


Eligibility criteria: Inclusion Criteria:

* Be able to provide written informed consent,
* Be a male or female at least 18 years of age,
* Be hospitalized for fluid overload requiring IV diuretic therapy
* History of use of diuretic therapy for CHF (including this admission),
* Be admitted to the hospital within 36 hours of the mandatory dose of IV furosemide 40 mg at between 2000 and 2200 hour on Day -1

Exclusion Criteria:

* Have had a myocardial infarction within 30 days prior to Day -1
* Be pregnant or breast-feeding
* Have received intravascular contrast material within the preceding 14 days; or have acute contrast nephropathy
* Have had implantation of an automated implanted cardiac defibrillator (AICD) or synchronization device within the preceding 7 days
* Currently require mechanical ventilation, ultrafiltration, or hemodialysis,
* Have symptomatic ventricular tachycardia
* Be admitted for heart transplant surgery or have had a heart transplant,
* Have any other concomitant life-threatening disease,
* Have participated in a clinical trial of an investigational drug or device within 30 days before randomization
* Have a positive urine pregnancy test (for women of child-bearing capacity)
* Have an allergy to soybean oil and/or eggs

Primary outcomes:
measure: To measure the diuretic effect of a single dose of the study medication (monotherapy) over six hours compared to a single dose of IV placebo (monotherapy) in CHF patients with renal impairment
timeFrame: 30 days
Secondary outcomes:
measure: To determine the optimal dose range of intravenous (IV) study medication combination with IV furosemide, with or without other diuretics, in preventing deterioration of renal function in CHF patients
timeFrame: 30 Days
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00338182: AZD1152 in Patients With Advanced Solid Malignancies
Official title: A Phase I, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1152 Given as a 2-hour or 48-hour Intravenous Infusions in Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumors
Keywords: Solid tumor
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-06-20
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 48-hour infusion every 14 days and as a 2-hour infusion for 2 consecutive days every 14 days in patients with advanced solid malignancies.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological confirmation of a solid, malignant tumour
* At least one measurable or non-measurable site of disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Exclusion Criteria:

* Participation in an investigational drug study within the 21 days prior to therapy or those who have not recovered from the effects of an investigational study drug
* Recent major surgery within 4 weeks prior to entry into the study

Primary outcomes:
measure: The incidence of adverse events (including adverse events detected via laboratory assessment, vital signs and ECG)
timeFrame: Throughout the study. Approximately 9 months for most patients.
Secondary outcomes:
measure: Assessment of pharmacodynamic biomarker changes
timeFrame: Biopsies of tumour at baseline and Cycle 1 [at pre-dose, after Screening to Day 1; and between Days 16-19 (preferrably within 24 hours of completing infusions on Day 17 (Part A) and Day 16 (Part B).]
Other outcomes:
Locations:
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: New York
country: United States
facility: Research Site
state: New York
Study officials:
affiliation: AstraZeneca
name: Emerging Oncology Medical Science Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06221982: TIPS for PH Patients: an Observational, Cohort Study
Official title: Transjugular Intrahepatic Portosystemic Shunt for Patients With Portal Hypertension: an Observational, Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cirrhosis Portal
Keywords: Transjugular intrahepatic porsystemic shunt
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing TIPS due to complications related to portal hypertension；

Brief summary: This is a single-center, prospective, observational study intended to include patients receiving TIPS for portal hypertension. Baseline data of enrolled patients were recorded, and samples of ascites, feces and urine were collected before surgery. Venous blood (superior mesenteric vein, hepatic vein, peripheral vein) from different parts of the entero-hepatic axis was retained during operation, and patients were followed up regularly for 2 years. The incidence of infection, hepatic encephalopathy, upper gastrointestinal hemorrhage and ascites in patients with portal hypertension who received TIPS intervention were observed within 3 months after operation. And the stent patency was observed within 2 years after surgery. To investigate the characteristics of microbial, protein and metabolic components on enterohepatic axis and their relationship with prognosis of patients with cirrhosis by detecting microbiome, proteome and metabolome.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing TIPS due to complications related to portal hypertension；
2. Age between 18 to 85 years;
3. Signed informed consent;

Exclusion Criteria:

1. Combined with liver cancer (out of the Milan criteria) or combined with other organ malignancies which had less than 3 months of expected survival;
2. Combined with severe cardiopulmonary disease (severe pulmonary hypertension and heart failure or severe heart valve insufficiency or renal insufficiency), the expected survival is less than 3 months;
3. Failure of TIPS procedure;
4. Women who plan to become pregnant or who are pregnant or breastfeeding；
5. Conditions deemed unsuitable for study participation by the investigator.

Primary outcomes:
measure: TIPS shunt dysfunction
timeFrame: two years
Secondary outcomes:
measure: death
timeFrame: 2 years
measure: liver transplant
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang hospital, Southern Medical Uiversity
state: Guangdong
Study officials:
References:
Clinical trial NCT01853020: Cannabinoids and Cerebellar-Motor Functioning
Official title: Cannabinoids and Cerebellar-Motor Functioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cannabis
Psychotic Disorders
Keywords: Cannabinoids
Eyeblink Conditioning
EBC
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2013-05-14
Enrollment: 57
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to characterize the dose-related effects of delta-9-tetrahydrocannabinol (∆9-THC) in healthy individuals on cerebellum-dependent motor functions.

Detailed description: The overall aim of the current proposal is to investigate whether acute, IV ∆9-THC administration mediates cerebellar versus forebrain-dependent associative learning in humans as assessed with eyeblink conditioning (EBC). In addition, a battery of motor function tests will also be administered (the CANTAB motor screening test, Grooved Pegboard Motor Task, paced finger tapping).

Eligibility criteria: Inclusion Criteria:

* Must have used cannabis at least once in their lifetime
* No cannabis use in the past month
* Men and women aged 21 to 35 years (extremes included) on the day of the first dosing

Exclusion Criteria:

* Hearing deficits
* Psychiatric or mental disorders
* Hearing Deficits

Primary outcomes:
measure: Cerebellum Dependent Associative Learning (% CRs)
timeFrame: Measured +15 minutes after infusion
measure: Cerebellum Dependent Associative Learning (CR Latency)
timeFrame: Measured +15 minutes after infusion
measure: Completion of the Grooved Pegboard Motor Task (Reaction Time/Accuracy)
timeFrame: Measured +45 minutes after infusion
measure: CANTAB Motor Screening Test (Reaction Time)
timeFrame: Measured +45 minutes after infusion
measure: CANTAB Motor Screening Test (Accuracy)
timeFrame: Measured +45 minutes after infusion
measure: Paced Finger Tapping (Correct Responses)
timeFrame: Measured +45 minutes after infusion
measure: Paced Finger Tapping (Reaction Time)
timeFrame: Measured +45 minutes after infusion
Secondary outcomes:
measure: THC intoxication, as measured by the Visual Analog Scale (Total Score)
timeFrame: Baseline; +45, +100, +240 minutes after infusion
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
References:
Clinical trial NCT04406220: The Effect of Large Versus Small Clog Size on Emergency Response Time
Official title: The Effect of Large Versus Small Clog Size on Healthcare Professional Emergency Response Time: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clothing
Occupational Injuries
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In many hospitals, clogs, usually white, are provided for healthcare workers. In our hospital, health care professionals from the department of intensive care medicine may be summoned to an emergency situation on a 24/7 basis. Clogs are thought to be of importance for running. Although clogs are available in several sizes, clog size is typically left to the discretion of the individual healthcare worker. Interestingly,

The primary goal of this randomized controlled trial is to assess if wearing large size clogs as compared to small size clogs results in increased running speed.

Participants will be randomized to small versus large clog size using a using randomly permuted blocks stratified by gender. Following randomization, participants will wear the clogs of allocated size and complete a standardized running course.

The primary endpoint is the time taken to complete the course.

The enrolment of 50 subjects would provide 80% power to show a 5-second difference in the response time at an average response time of 30 seconds with a 6 second standard deviation.

The ethical committee judged the study protocol exempt from extensive review.


Eligibility criteria: Inclusion Criteria:

* Healthcare workers aged 18 years or older.

Exclusion Criteria:

* Inability to run on clogs.

Primary outcomes:
measure: Time to complete the running course
timeFrame: Follow-up until 60 minutes.
Secondary outcomes:
measure: Adverse events
timeFrame: Follow-up until 60 minutes.
measure: Time to complete the running course for specific subgroups: By gender, job function, level of fitness.
timeFrame: Follow-up until 60 minutes.
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location VUmc
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Paul Elbers, MD, PhD
role: STUDY_CHAIR
References:
citation: Elbers PWG, de Grooth HJ, Girbes ARJ. The effect of small versus large clog size on emergency response time: A randomized controlled trial. J Crit Care. 2020 Dec;60:116-119. doi: 10.1016/j.jcrc.2020.07.028. Epub 2020 Aug 8.
Clinical trial NCT02040220: Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Eylea for Central Retinal Vein Occlusion (CRVO)
Official title: Special Drug Use Investigation of EYLEA for CRVO
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Vein Occlusion
Keywords: CRVO, Macular edema, Aflibercept, anti-VEGF
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2014-01-20
Enrollment: 385
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female and male patients with a diagnosis of CRVO will be enrolled after the decision for treatment with EYLEA has been made by the investigator. Those patients prescribed EYLEA previously will not be included in this study. Physicians should consult the full prescribing information for EYLEA before enrolling patients and familiarize themselves with the safety information in the product package label. Eligible patients who receive EYLEA will be enrolled and documented in the eCRF.

Brief summary: This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of CRVO. The investigator will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert prior to enrolling the patient in this study.

The observation period for each patient starts when therapy with EYLEA is initiated. The enrollment period is 2 years. Patients will be followed for a time period of 2 years or until it is no longer possible (e.g. lost to follow-up) within the 2 years.

For each patient, data are collected as defined in the case report form at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice).

There will interim analysis of study data: 6 months after last patient first visit and J-PSUR(Japanese-Periodic Safety Update Report )


Eligibility criteria: Inclusion Criteria:

* Patients who start EYLEA treatment for CRVO

Exclusion Criteria:

* Patients who have already received EYLEA treatment
* Patients who are contraindicated based on approved label

Primary outcomes:
measure: Number of episodes of adverse drug reactions and adverse events(serious or non-serious, related or not related, ocular or non ocular)
timeFrame: 6 months after start of treatment with the drug
Secondary outcomes:
measure: Effectiveness (visual acuity)
timeFrame: 6months after start of treatment with the drug
measure: Effectiveness (retina thickness)
timeFrame: 6months after start of treatment with the drug
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: