louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06067724: Effect of Pelvic Control Exercises in Stroke
Official title: Effect of Pelvic and Trunk Control Exercises on Function Outcome of Affected Upper Extremity in Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 40
Sex: MALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to investigate the combined effect of pelvic and trunk control exercises on muscle performance of affected upper extremity in stroke patients.

Detailed description: The study conducted on forty stroke patients. They assessed by Biodex System 3 Pro Isokinetic, Modified Ashworth Scale(MAS), Fugel Meyer Assessment scale (FMAS), Box and block test and hand grip dynamometer. Patients divided into control group and study group. The control group treated by a traditional physical therapy program.The study group treated by the traditional physical therap program in addition to pelvic and trunk control exercises for 40 min.

Eligibility criteria: Inclusion Criteria:

* Patient's age will range from 45 - 60 years.
* Muscle tone grade will range from 1 to 1+ according to modified Ashworth scale.
* Duration of illness will range from 6 to 18 months after stroke onset.
* Ability of the patient to stand without assistive devices.

Exclusion Criteria:

* • Other neurological or musculoskeletal disorders that might affect pelvic alignment such as severe arthritis, knee surgery, total hip joint replacement, lower limb fractures, contractures of fixed deformity or leg length discrepancy.

  * Severe chronic back and/or knee pain that might affected standing posture.
  * Recurrent stroke
  * Shoulder or upper limb injury that might affect the recovery.
  * Perceptual or cognitive dysfunctions.
  * BMI \> 30

Primary outcomes:
measure: Biodex System 3 Pro Isokinetic
timeFrame: Six weeks after the beginning of the intervention
Secondary outcomes:
measure: Fugl-Meyer Assessment for upper extremity
timeFrame: Six weeks after the beginning of the intervention
measure: Box and block test
timeFrame: Six weeks after the beginning of the intervention
measure: Hand grip dynamometer
timeFrame: Six weeks after the beginning of the intervention
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy labs at Cairo University
city: Giza
country: Egypt
facility: Faculty of physical therapy labs at Cairo University
Study officials:
References:
Clinical trial NCT01181024: A Study on Safety, Tolerability and Pharmacokinetics of RO5303253 in Healthy Volunteers and Patients With Chronic Hepatitis C Genotype 1
Official title: A Single Ascending Dose Tolerability and Pharmacokinetic Study of RO5303253 With a Pilot Food-effect Investigation in Healthy Subjects and Exploratory Pharmacokinetic, Pharmacodynamic, and Safety Assessments in Chronic Hepatitis C Genotype 1 Patients Following 5 Days of Oral Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C, Chronic, Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-08-13
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This randomized, double-blind, placebo controlled, 3 part study will assess the safety, tolerability and pharmacokinetics of RO5303253 in healthy volunteers and patients with chronic hepatitis C genotype 1. In Part A, cohorts of healthy volunteers will be randomized to receive single ascending doses of RO5303253 or placebo. In Part 2, healthy volunteers will receive a single dose of RO5303253 or placebo in a cross-over design (with a washout period of at least 7 days) to assess food effects on pharmacokinetics. In Part 3, patients with chronic hepatitis C will be randomized ro receive either RO5303253 or placebo for 5 days.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers or patients with chronic hepatitis C genotype 1, 18 to 60 years of age
* Patients must be treatment-naïve for antiviral therapy for chronic hepatitis C with interferon based therapy
* Body mass index (BMI) 18 - 32 kg/m2 inclusive, minimum weight 45 kg
* Females must be surgically sterile or menopausal
* Male subjects and their partners of childbearing potential must use 2 methods of contraception throughout the study and for 70 days after the last dose

Exclusion Criteria:

* Pregnant or lactating women and male partners of women who are pregnant or lactating
* Women with reproductive potential
* Positive for hepatitis B or HIV (or hepatitis C for healthy volunteers) at screening
* For hepatitis C patients: decompensated liver disease or impaired liver function, evidence of cirrhosis documented at any time, presence or history of non-hepatitis C chronic liver disease

Primary outcomes:
measure: Safety and tolerability: Adverse events, laboratory parameters, ECG, blood pressure
timeFrame: approximately 6 months
measure: Pharmacokinetics: Plasma and urine concentrations of RO5303253 and its main metabolite RO1080713
timeFrame: approximately 6 months
Secondary outcomes:
measure: Effect of food intake on pharmacokinetics in healthy volunteers
timeFrame: Days 1-4
measure: Pharmacodynamics (viral responses) and drug resistance profiling in chronic hepatitis C patients
timeFrame: From baseline to Day 15
Other outcomes:
Locations:
city: Grafton
country: New Zealand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00698724: Comparing Optical Coherence Tomography (OCT) and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone Acetate 1% and Standard Presurgical Care
Official title: A Prospective, Randomized Single-Masked Clinical Trial Comparing OCT and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone Acetate 1% and Standard Presurgical Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataracts
Lead sponsor: Bp Consulting, Inc
Sponsor class: NETWORK
First posted: 2008-06-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of twice-daily topical bromfenac (Xibrom) ophthalmic solution alone versus twice-daily topical Xibrom with prednisolone acetate 1% three-times daily on visual acuity and OCT measurements.


Eligibility criteria: Inclusion Criteria:

* Male or female at least 18 years of age.

  * Expectation of 20/25 best corrected visual acuity (BCVA) post-operatively.
  * Patients should be in good general health and devoid of recognized risk factors for CME.
  * Patients with systemic diseases are eligible only if there were no ocular manifestations of the disease (specifically diabetics without retinopathy)
  * Patients must be likely to provide informed consent, take study medications as directed, and complete all study visits
  * Only one eye of each treated patient may be included in the study

Exclusion Criteria:

* Any known contraindications to any study medication or their component
* Presence of uncontrolled systemic disease
* Required use of other ocular medications during the study

  o Artificial tears may be used
* Diabetics with any clinically evident or history of retinopathy
* Individuals with age-related macular changes, epi-retinal membranes, other retino-vascular diseases and/or other macular disorders thought to have a less than 20/25 surgical outcome expectation
* Abnormal pre-operative OCT (if obtainable)

Primary outcomes:
measure: OCT
timeFrame: 2-4 months
Secondary outcomes:
measure: Visual Acuity
timeFrame: 2-4 months
Other outcomes:
Locations:
city: Tarpon Springs
country: United States
facility: St. Luke's Cataract and Laser institute
state: Florida
Study officials:
affiliation: St. Luke's Cataract and Laser Institute
name: James Gills, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01782924: A Phase 3 Clinical Study of KHK4827
Official title: An Extension Study in Subjects With Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-02-04
Enrollment: 145
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate safety and efficacy of long-term exposure of KHK4827 in subjects with moderate to severe plaque psoriasis who have completed the preceding Study 4827-002.


Eligibility criteria: Inclusion Criteria:

* Subject has voluntarily signed the written informed consent form to participate in this study
* Subject has completed the week 12 evaluation of Study 4827-002

Exclusion Criteria:

* Subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration)
* Subject has been judged to be ineligible for participation in the study by the investigators/subinvestigators

Primary outcomes:
measure: Incidence and types of adverse events and adverse reactions
timeFrame: 52 weeks
measure: Laboratory values and vital signs
timeFrame: 52 weeks
measure: Development of anti-KHK4827 antibody
timeFrame: 52 weeks
Secondary outcomes:
measure: Percent improvement from baseline in Psoriasis Area and Severity Index (PASI)
timeFrame: 52 weeks
measure: A 50% improvement in PASI (PASI 50), PASI 75, PASI 90 and PASI 100 response
timeFrame: 52 weeks
measure: Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)"
timeFrame: 52 weeks
measure: sPGA of "clear (0)"
timeFrame: 52 weeks
measure: Body surface area involvement (BSA) of lesion
timeFrame: 52 weeks
measure: American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis)
timeFrame: 52 weeks
measure: Profiles of pharmacokinetics
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Chiyoda-ku
country: Japan
facility: For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
state: Tokyo
Study officials:
References:
Clinical trial NCT02167724: Multicentre Evaluation of Bucco-dental Health in Patients With Schizophrenia in Côte d'Or
Official title: Multicentre Evaluation of Bucco-dental Health in Patients With Schizophrenia in Côte d'Or
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2014-06-19
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The aim of this study is to know the bucco-dental status of patients with schizophrenia in Côte d'Or.

Participation in this study will last only as long as it takes to:

* carry out a bucco-dental examination: evaluation of dental plaque and calculus
* take a blood sample to assess needs in vitamin C (only for patients included at DIJON CHU and CHS Chartreuse)
* complete a 30-minute questionnaire: clinical data and answers to questions concerning dental hygiene and eating habits.


Eligibility criteria: Inclusion Criteria:

* Patients who have provided consent
* Patients over 18 years of age
* Persons with schizophrenia according to the ICD 10 criteria and followed in hospital (complete or day hospital) in one of the hospitals taking part in the study

Exclusion Criteria:

* Adult under guardianship
* Patient not covered by national health insurance
* Pregnant or breast-feeding women
* Patients not stabilized from a psychiatric viewpoint
* Patients experiencing an acute psychiatric episode
* Impossibility to understand and /or poor understanding of French

Primary outcomes:
measure: Calculate the DMF index (Decayed, Missing, Filled)
timeFrame: Baselines
Secondary outcomes:
measure: Calculate the simplified Oral Health Index (OHI-S)
timeFrame: Baselines
measure: Perception of oral health of patients observed
timeFrame: Baselines
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHS La Chartreuse
city: Dijon
country: France
facility: CHU de DIJON
city: Semur-en-Auxois
country: France
facility: CH Semur-en-Auxois
Study officials:
References:
Clinical trial NCT00889824: Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
Official title: Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dizziness
Keywords: Chronic imbalance
vestibular disorders
balance prosthesis
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Barron Associates, Inc.
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2009-04-29
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this project is to provide individuals that have a balance deficit with a device that will give them signals that they can feel (vibrations) in order to help them maintain a correct sense of balance and perception of place in the environment.

Detailed description: This proposal addresses a National Institute on Deafness and Other communication Disorders (NIDCD) research topic that emphasizes the "development of assistive devices for balance disorders". The proposed work will evaluate the assistive efficacy of such a balance prosthesis in a population of chronic imbalance patients spanning a wide range of disease etiologies.

Eligibility criteria: Inclusion Criteria:

* Ambulatory patients who have had chronic imbalance for at least one year, and have reached a functional performance plateau with respect to their balance adaptation.

Exclusion Criteria:

* Neurological disorders other than chronic balance disorders, as determined by medical history and neurological screening procedure.
* Any medical condition as determined by the health questionnaire that would interfere with performance on the postural stability evaluation tests.
* Peripheral neuropathies of the lower extremities.
* Subjects who are unwilling or unable to adhere to all study requirements, including completion of the training period, evaluation tests, and return to clinic for a follow-up visit.

Primary outcomes:
measure: Change in Dynamic Gait Index (DGI) From Baseline to 6 Weeks.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Joel A Goebel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01032824: Self-Managing HIV and Chronic Disease
Official title: Community-based Self-management of HIV and Chronic Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: Complementary Therapies
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2009-12-16
Enrollment: 452
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to conduct a randomized control trial of a behavioral intervention delivered by counselors via telephone to determine if this is an efficacious method for improving medication adherence and health-related quality of life for persons who are 50 and older and living with HIV/AIDS and other chronic conditions.

Detailed description: 450 adult HIV+ patients aged 50 or older will be randomized to one of three arms. 150 will be assigned to receive a series of ten 30-minute phone calls every two weeks from a counselor. 150 will be assigned to an attention-matched comparison arm, and will receive 10 sessions in a didactic telephone group. 150 will be assigned to a information-matched control arm and will receive the book Living Well with HIV \& AIDS. Letters will be sent by AIDS Service Organizations inviting interested clients to call the study's 800 number to learn more about the study and to be screened for enrollment. Posters and brochures will also be posted in public areas of the ASOs. The individualized intervention combines problem-solving, with motivation and self-management. This trial will allow us to evaluate the effectiveness of a multi-component intervention on both specific HIV behavioral outcomes and non-disease-specific outcomes.

Eligibility criteria: Inclusion Criteria:

* age 50 years or older
* HIV-positive serostatus
* currently prescribed antiretroviral medication
* antiretroviral nonadherence reported in past 30 days
* provision of oral informed consent

Exclusion Criteria:

* hearing problems that preclude participation in a telephone study
* presence of probable dementia or acute psychosis detectable by screening interview

Primary outcomes:
measure: antiretroviral (ART) adherence
timeFrame: Pre-treatment Screening and Baseline, 6, 9, and 12 months f/u.
measure: health-related quality of life (physical, mental health, and social function)
timeFrame: Baseline, 6, 9, 12 mo f/u
Secondary outcomes:
measure: chronic disease treatment adherence
timeFrame: baseline, 6, 9 and 12 months f/u
measure: Self-efficacy and readiness to change
timeFrame: baseline, 6, 9, 12 months f/u
measure: perceived stress and depression
timeFrame: baseline, 6, 9, and 12 months f/u
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Research Institute
state: Washington
Study officials:
affiliation: Group Health Research Institute
name: Sheryl L Catz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00762424: Effect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis
Official title: Effect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Stone
Keywords: Kidney stone
Ureterolithiasis
Tamsulosin
Flowmax
Emergency Department
Lead sponsor: WellSpan Health
Sponsor class: OTHER
First posted: 2008-09-30
Enrollment: 53
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: Tamsulosin (Flowmax)is approved by the FDA for the treatment for enlarged prostate. Several studies regarding the use of Tamsulosin for the treatment of lower kidney stones have been carried out in the non-Emergency Department setting. This study will compare Tamsulosin 0.4 mg with placebo in regards to rate and time of stone passing and will also look at amount of pain. The purpose of this study is to compare the usefulness of Tamsulosin versus placebo on time to stone passage and pain relief in Emergency Department patients with kidney stones.


Eligibility criteria: Inclusion Criteria:

* 18 y.o. or older
* diagnosed with a kidney stone less than or equal to 10 mm determined by CT scan
* physician has made the decision that you will be discharged to home
* must be able to take study medication for up to 10 days and strain your urine
* must be able to keep a record of pain medication taken and complete a pain scale rating

Exclusion Criteria:

* patients currently taking: Tamsulosin (Flowmax), calcium channel blockers, beta blockers, alpha blockers, Sildenaphil (Viagara), Tadalaphil (Cilias), Warfarin (Coumadin, Jantoven), Cimetidine (Tagamet, Tagamet HB)
* patients with a clinical and laboratory signs of: urinary tract infection, multiple kidney stones, diabetes, kidney failure, hypotension, pregnancy, fever
* patient known to have hypersensitivity to Tamsulosin
* patient history of cataract surgery
* inability of patient to perform visual pain scale
* allergy or intolerance to acetaminophen/oxycodone
* patient is unable to understand informed consent
* prisoners

Primary outcomes:
measure: Time of Stone Passage
timeFrame: 10 Days
Secondary outcomes:
Other outcomes:
Locations:
city: York
country: United States
facility: York Hospital Emergency Department
state: Pennsylvania
Study officials:
affiliation: WellSpan Health
name: Marc Pollack, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00320424: Hip Fracture Study of GSK576428 (Fondaparinux Sodium)
Official title: Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism After Hip Fracture Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thromboembolism
Keywords: Xa factor
VTE
MOSLL
pentasaccharide
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-05-03
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is requested by PMDA to confirm the efficacy and the safety for HFS.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing hip fracture surgery within 10 days following the time of fracture of the hip (proximal femur) (or following the time of fracture estimated from trauma).

Exclusion Criteria:

* Active, clinically significant bleeding (excluding drainage).

Primary outcomes:
measure: Rate of Major Bleeding During Treatment Period
timeFrame: From the first study drug injection up to Day 17
Secondary outcomes:
measure: Rate of PE During Treatment Period
timeFrame: Up to Day 17
measure: Rate of DVT During Treatment Period
timeFrame: Up to Day 17
measure: Rate of Proximal DVT During Treatment Period
timeFrame: Up to Day 17
measure: Rate of Distal Only DVT During Treatment Period
timeFrame: Up to Day 17
measure: Number of Participants With Major Bleeding During Treatment Period
timeFrame: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
measure: Number of Participants With Minor Bleeding and Any Bleeding (Major and/or Minor Bleeding)
timeFrame: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
measure: Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death
timeFrame: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
measure: Number of Transfused Participants
timeFrame: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
measure: Summary of Units Transfused
timeFrame: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
measure: Rate of Symptomatic DVT
timeFrame: Up to Day 17
Other outcomes:
Locations:
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: