louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04312581: Extracorporeal Shock Wave Therapy on Wrist and Hand Functions in Spastic Chronic Stroke Patients
Official title: Effect of Extracorporeal Shock Wave Therapy on Wrist and Hand Functions in Spastic Chronic Stroke Patients :Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Spasticity
Shock Wave
Keywords: shock wave
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 40 chronic stroke patients with upper limb spasticity will randomly divided into two groups. First group will receive 3 sessions of radial extracorporeal shock wave therapy (rESWT) with one week apart without cessation of current physical therapy, while the second group will continue to receive conventional rehabilitative program.

Assessment will be done at baseline, 2 weeks after rESWT and 3 months after rESWT using Modified Ashworth Scale, Fugl Meyer Assessment for hand function and wrist control, motricity index for pinch grip and Hmax/ Mmax amplitude ratio of flexor carpi radialis muscle.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic stroke with disease duration more than one year will be included in the study with stable modified Ashworth scale for upper limb spasticity ranged from 1+ to 4.

Exclusion Criteria:

* Patients more than 65 years,Patients with double stroke and patients with fixed contractures of wrist \& hand ,Patients received anti-spastic measures (botulinum toxins, nerve block) within 6 months,Also patients with contraindication to extra-corporeal shock wave therapy i.e. malignancy at treatment area, coagulopathies, active infection (viral or TB), o bleeding wounds, and patients with pacemakers will be excluded

Primary outcomes:
measure: Modified Ashworth Scale
timeFrame: Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)
measure: Fugl-Meyer Assessment
timeFrame: Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)
measure: Motricity Index
timeFrame: Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)
measure: Hmax / Mmax amplitude ratio
timeFrame: Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university hospital
state: Gharbia
Study officials:
References:
citation: Li TY, Chang CY, Chou YC, Chen LC, Chu HY, Chiang SL, Chang ST, Wu YT. Effect of Radial Shock Wave Therapy on Spasticity of the Upper Limb in Patients With Chronic Stroke: A Prospective, Randomized, Single Blind, Controlled Trial. Medicine (Baltimore). 2016 May;95(18):e3544. doi: 10.1097/MD.0000000000003544.
Clinical trial NCT01921881: Does the Natural Medicinal Plant St John's Wort Affect the Glucose Tolerance in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: Glucose tolerance
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2013-08-13
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The goal of the study is to examine if healthy individuals that ingest St John's wort will have a significantly difference in glucose tolerance.


Eligibility criteria: Inclusion Criteria:

* 18-40 years
* Males
* Fasting plasma-glucose \< 7.0 mmol/L
* Glycosylated haemoglobin A1c within reference or clinically insignificant deviation hereof
* Body mass index \< 30 kg/m\^2

Exclusion Criteria:

* Hypersensitivity to St John's wort
* Chronical or daily alcohol abuse
* Known liver disease
* Ingestion of drugs requiring prescription, except locally acting drugs

Primary outcomes:
measure: Glucose area under curve (AUC) 0-2 hours
timeFrame: Glucose concentration 0, 15, 30, 45, 60, 90 and 120 after glucose ingestion
Secondary outcomes:
measure: St John's wort pharmacokinetics
timeFrame: At time=0
measure: Other metabolic markers
timeFrame: At time points, 0, 15, 30, 45, 60, 90, 120 minutes after glucose ingestion
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Department of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark
Study officials:
affiliation: University of Southern Denmark
name: Kim Brøsem, Professor, MD
role: STUDY_DIRECTOR
affiliation: University of Southern Denmark
name: Per Damkier, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern Denmark
name: Tore B. Stage, MSc Pharm
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03942081: Diabetic Foot Ulcer Imaging- Study 2
Official title: Testing the Accuracy and Feasibility of Diabetic Foot Ulcer Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Foot Ulcer
Foot Ulcer, Diabetic
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Fraternal Order of the Eagles Diabetes Research Center
First posted: 2019-05-08
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: All study procedures will occur during one appointment. The research team will measure the size of the foot ulcer (if one is present) and multiple photos will be taken with a smart phone camera and thermal camera. Demographic information will be obtained from the medical record.

Detailed description: The research procedures consist of a) a research assistant measuring the size of the foot ulcer (for ulcer patients), b) patients having pictures of their feet taken with a smart phone under 4 conditions- 1) photos taken by researchers, 2) photos taken by the patient by hand, 3) photos taken by the patient with a selfie stick, and 4) photos taken by a 3rd party (e.g., friend/family member of patient). If the patient is not able to take photographs under any of the conditions, that condition will be excluded. In addition to photos being taken with a smart phone, additional photos will be taken with a thermal camera by the research team to determine if there is a difference in ulcer size depending on type of camera used. It is anticipated that procedures will last between 15 and 45 minutes. There is no long-term follow-up. If a patient returns to the clinic they will be asked if they wish to complete all study procedures again. Once the patient has left the clinic, the research team will check the medical record for: age, sex, race, ethnicity, BMI, co-morbidities, and zip code (to determine if patient lives in an urban or rural location).

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Type 1 or Type 2 Diabetes
* Has a current foot lesion
* Receiving care through University of Iowa Hospitals and Clinics (UIHC) Iowa River Landing Diabetes Clinic, UIHC Internal Medicine Clinic, or UIHC Orthopedic Clinic.

Exclusion Criteria:

* Cognitive impairment that prevents consent
* Lack of fluency in speaking or understanding English
* Known aversion to research studies

Primary outcomes:
measure: Foot Ulcer Size
timeFrame: 45 minutes
Secondary outcomes:
measure: Quality of Photos: 1 - 5 scale
timeFrame: 45 minutes
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Linnea Polgreen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06370481: HIV, Equity, and Addiction Training (HEAT) Program
Official title: HIV, Equity, and Addiction Training (HEAT) Program
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Substance Use Disorders
Hiv
Opioid Use Disorder
Stimulant Use (Diagnosis)
Keywords: Alabama
Ryan White Clinics
HIV treatment
Substance use disorder treatment
Telemedicine
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This project is a pilot study to determine the feasibility and acceptability of a telemedicine intervention for substance use disorder service delivery in diverse people living with HIV in Alabama.

Detailed description: The contemporary drug crisis and the COVID-19 pandemic have exposed the complex syndemics of addiction and infectious diseases: rising rates of substance use disorder (SUD) have outpaced our ability to respond with a limited healthcare workforce and public health capacity. SUD is increasing in those living with and at risk for HIV, and infectious consequences of SUD, like hepatitis C, have continued, unmitigated, in rural parts of the U.S. where many states lack Medicaid expansion, syringe service programs, and public health infrastructure to respond to the drug crisis and comorbid infections. Systemic racism and regressive policies in the Deep South criminalize people who use drugs, creating additional barriers to care, HIV prevention, and addiction treatment. As a result, people who use drugs rarely receive comprehensive addiction and HIV treatment. Yet telemedicine has the potential to overcome these barriers and bypass the constraints of a brick-and-mortar clinic to link vulnerable people, including those with HIV, to care. Although telemedicine has become mainstream in recent years, few studies have evaluated telemedicine for SUD in the Deep South from the perspective of patients and providers.

Eligibility criteria: Inclusion Criteria:

* Receiving services at HIV clinics in Alabama
* Reported opioid and/or stimulant misuse
* 18 years of age or older

Exclusion Criteria:

* Receipt of SUD clinical care other than through HIV provider/clinic in the last 3 months
* Inability to engage in interviews independently without support (e.g., cognitive impairment)
* Currently psychotic
* Actively suicidal: presents with a suicide attempt or suicidal ideation

Primary outcomes:
measure: Percent of participants who have a follow-up healthcare visit
timeFrame: 1 month, 2 months, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Ellen F Eaton, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00507481: Evaluation of Risk Factors of Sleep Quality in Intensive Care Unit
Official title: Evaluation of Risk Factors of Sleep Quality in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorders
Delirium
Keywords: Sleep
ICU
Delirium
Post surgical ventilated patients
ICU patients
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2007-07-26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICU postsurgical patients who needed mechanical ventilation for more than 48 hr admitted to the general ICU

Brief summary: The aim of this study was to investigate the relationship between sleep disturbances and delirium in surgical ICU patients. The study set up to test the hypothesis that the occurrence of delirium is associated to the alteration of sleep quality and quantity observed in the critically ill patients.

Detailed description: Sleep disorders are an important clinical entity affecting outcome in respiratory, cardiovascular, metabolic and psychiatric disorders and exacting a potentially significant toll on patients at both a personal and socio-economic level.Delirium is a common organ dysfunction in the critically ill patients characterized by an acute onset of impaired cognitive function \[REF\] associated with prolonged ICU and hospital stay, nosocomial pneumonia, and death.

Eligibility criteria: Inclusion Criteria:

* Adult, postsurgical patients who needed mechanical ventilation for more than 48 hr admitted to the general ICU

Exclusion Criteria:

* Defined a priori
* Were history of chronic dementia, psychosis, mental retardation, stroke syndrome or other primary neurologic disease
* Patient refusal to participate
* Alcohol and drug abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Turin
country: Italy
facility: ICU University S.G.Battista Hospital
city: Turin
country: Italy
facility: Intensive care Unit S.giovanni Battista Hospital
Study officials:
affiliation: University of Turin, Italy
name: Marco V Ranieri, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06412081: Lung Ultrasound for Physiotherapy in Hospitalized Patients With Respiratory Complications
Official title: The Value of Point-of-care Lung Ultrasound for Physiotherapy in Hospitalized Patients With Acute Respiratory Symptoms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Complication
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalization in a general ward in the University Hospital Saint-Luc.

Brief summary: This study aims to evaluate the relevance of using point-of-care lung ultrasound (LUS) in modifying the physiotherapist's treatment plan for patients hospitalized in a general ward.

Detailed description: Hospitalized patients often confront respiratory issues stemming from diverse causes, such as pneumonia. Physiotherapists rely on a range of clinical and imaging data to inform their treatment decisions. Yet, they face challenges due to the absence of readily accessible, sensitive, specific, and reliable measurements to tailor the most effective physical therapeutic interventions based on individual clinical scenarios. Point-of-care Lung Ultrasound (LUS) holds promise in addressing these existing gaps.

This study aims to evaluate the impact of integrating LUS into clinical practice by comparing physiotherapists' initial clinical assessments and treatment plans with those made after incorporating LUS findings in patients admitted to a general ward.

Eligibility criteria: Inclusion Criteria:

* Hospitalization in a general ward
* Acute respiratory symptoms (\< 48h)
* Chest X-ray available within 24h before or after the use of LUS

Exclusion Criteria:

* Any conditions precluding the use of LUS (thoracic skin lesions, thoracic bandage, subcutaneous emphysema)
* Inability to understand instructions due to cognitive impairment or due to language barrier

Primary outcomes:
measure: Percentage of change of treatment plan
timeFrame: Before and Immediately after the use of LUS (10-min interval)
Secondary outcomes:
measure: Agreement between the events observed on LUS and the events observed on Chest X-Ray
timeFrame: At baseline
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT00471510: Dose-Ranging Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss
Official title: A Phase 2 Multicenter, Randomized, Placebo-Controlled, Parallel Group Dose-Ranging Study to Evaluate the Safety and Efficacy of Topical NEOSH101 in the Treatment of Androgenetic Alopecia in Men
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Androgenetic Alopecia
Keywords: androgenetic alopecia
male pattern hair loss
male pattern baldness
androgenetic alopecia or male pattern hair loss
Lead sponsor: Neosil, Inc.
Sponsor class: INDUSTRY
First posted: 2007-05-10
Enrollment: 140
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of three doses of topical NEOSH101 applied once-daily (qd) for 16 weeks in men with thinning hair in the top and center of the scalp (Norwood/Hamilton grades III-IV androgenetic alopecia). Four equally sized treatment groups (35 men each) will receive either NEOSH101 0.5%, NEOSH101 1.0%, NEOSH101 2.0% or placebo. A 12-week observation period will follow the treatment period.


Eligibility criteria: Inclusion Criteria:

* Men, aged 18 to 49 years, in general good health
* Norwood/Hamilton grades III - IV androgenetic alopecia, with thinning hair in the vertex area

Exclusion Criteria:

* Concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug
* Treatment with a systemic or locally acting medication which may interfere with the study objectives, such as minoxidil treatment in the 6 months prior to study day 1, finasteride treatment in the 12 months prior to study day 1, or treatment with other investigational hair growth products in the 6 months prior to study day 1

Primary outcomes:
measure: Hair density, hair growth rate, hair diameter as measured using the Trichoscan method
timeFrame: 16 weeks application treatment period followed by 12 weeks observation period
Secondary outcomes:
measure: Assessment score of dermal tolerability
timeFrame: 16 weeks application treatment period followed by 12 weeks observation period
measure: Physician's global assessment score
timeFrame: 16 weeks application treatment period followed by 12 weeks observation period
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: bioskin Institute for Dermatological Research and Development GmbH
Study officials:
affiliation: bioskin Institute for Dermatological Research and Development GmbH
name: Johannes Gassmueller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00346710: Patient Experiences in Rheumatology
Official title: Communication Skills in Rheumatology Fellows
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Rheumatic Disease
Keywords: communication
patient experience
fellowship training
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2006-06-30
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: Information was entered by mistake by a Research Assistant. Study never went beyond the initial discussion phase.


Eligibility criteria: All adult patients who have an appointment scheduled at the Rheumatology Clinic at Good Samaritan Hospital, can speak and read English and are willing and capable of providing informed consent are eligible to participate. All fellows in the Rheumatology Fellowship training program will participate.

Primary outcomes:
measure: Changes in patient and provider satisfaction scores will be measured at baseline and 6 months using self-report.
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Clifton O Bingham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02736110: Registry of Celution Device for the Processing of Adipose Derived Regenerative Cells (ADRCs) to Treat Osteoarthritis
Official title: Registry of Celution Device for the Processing of Adipose Derived Regenerative Cells (ADRCs) for Intra-articular Delivery to Knees With Osteoarthritis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Osteoarthritis
Keywords: Osteoarthritis, knee
Lead sponsor: Cytori Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-04-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that are schedule to receive or have received Adipose Derived Regenerative Cells (ADRCs) prepared by the Celution device to treat osteoarthritis in the knee.

Brief summary: This registry study will compile information from patients that are scheduled to receive or have received Adipose Derived Regenerative Cells (ADRCs) prepared by the Celution device to treat osteoarthritis in the knee.


Eligibility criteria: Inclusion Criteria:

* Males or females \> 18 years of age
* Diagnosis of osteoarthritis in one or both knees with Kellgren Lawrence grade ≥ 2 at x-ray evaluation or MRI findings of degenerative changes
* Pain with or without swelling in the affected area for \>4 months

Exclusion Criteria:

* Know spine or disc disease or symptomatic nerve impingement contributing to pain in the affected limb
* History of documented nerve damage in the affected limb
* Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test prior to procedure.

Primary outcomes:
measure: Change in knee pain as assessed by the knee injury and osteoarthritis outcome score (KOOS)
timeFrame: 90 days
Secondary outcomes:
measure: Change in knee pain as assessed by the knee injury and osteoarthritis outcome score (KOOS)
timeFrame: Days 7, 30, 180 and 365
measure: Change in knee pain assessed by VAS Assessments
timeFrame: Days 7, 30, 90, 180 and 365
measure: Change in knee function as assessed by the Lysholm Knee Scoring Scale
timeFrame: Days 7, 30, 90, 180 and 365
measure: Change in WORMS scoring (Whole Organ MRI of the knee)
timeFrame: Days 180 and 365
measure: Change in knee function as measured by Tegner Activity Scale
timeFrame: Days 7, 30, 90, 180 and 365
measure: Change in knee function as measured by the Lower Extremity Functional Scale
timeFrame: Days 7, 30, 90, 180 and 365
Other outcomes:
Locations:
Study officials:
affiliation: Cytori Therapeutics
name: Steven Kesten
role: STUDY_CHAIR
References: