louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01065740: Optimized Supervised Education Program for Peripheral Arterial Disease
Official title: Optimized Supervised Education Program for Peripheral Arterial Disease: Ambulatory Management With Patient Education
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Peripheral arterial disease
Patient education
Physical activity coaching
Lifestyle modifications
Walking capacity
6 minutes walking test
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2010-02-09
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Peripheral arterial disease (PAD) is a frequent and serious chronic disease witch is undertreated. The recommended management of PAD include pharmacological approach and lifestyle modifications. Patient education help to reach this outcome. Our study propose to compare patient education management with physical activity coaching to usual care.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 75 years
* With peripheral arterial disease
* Who accept to follow a patient education program

Exclusion Criteria:

* Permanent limb ischemia
* Revascularisation programmed in the 6 next months
* Other severe prognostic disease
* Difficulties to obtain patient consent because of language or understanding

Primary outcomes:
measure: 6 minutes walking test
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
References:
Clinical trial NCT04969640: Role of Anterior Segment Optical Coherence Tomography in Infectious Keratitis
Official title: Role of Anterior Segment Optical Coherence Tomography in Staging and Evaluation of Treatment Response in Infectious Keratitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infective Keratitis
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any case with infective keratitis

Brief summary: To evaluate the role of anterior segment optical coherence tomography in follow up of infectious keratitis and assessment of response to treatment.

Detailed description: 50 patients with proven infectious keratitis clinically will be included in the study.

The following will be performed for all patients in initial visit and follow up:

* Slit lamp examination and photography.
* Visual acuity assessment.
* Anterior segment optical coherence tomography.

  1. The central corneal thickness (CCT) (extracted from pachymetry map),
  2. Minimal corneal thickness (MCT) (extracted from pachymetry map)
  3. Corneal thickness at the site of the lesion (CTL) (extracted from pachymetry map or the sum of STL+ CETL)
  4. Stromal thickness at the center of the lesion (STL) stromal lesion (extracted from stromal map)
  5. Corneal epithelial thickness over the stromal lesion (CETL) at the center of the lesion (extracted from epithelial map)

Eligibility criteria: Inclusion Criteria:

* Any case with infectious keratitis (any age) either received medical treatment or not, attending to our department will be included in the study.

Exclusion Criteria:

* Cases with healed infectious keratitis.
* Cases presented from the start with severe corneal affection and melting.

Primary outcomes:
measure: criteria of lesion on optical coherence tomography
timeFrame: 1 month
measure: width of lesion on optical coherence tomography
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Minia University
name: Ahmed Abdelghany, ASS PROF
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03548740: Diversity Analysis of Vaginal Microbiota on Women With High-risk Human Papillomavirus Infection
Official title: Diversity Analysis of Vaginal Microbiota on Women With High-risk Human Papillomavirus Infection and Cervical Cytological Abnormalities.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Papillomavirus Infections
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-06-07
Enrollment: 151
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Group A: HPV positive, and the participants who have not taken drugs and physical therapy in the past six months, nor have chronic diseases (such as DM), take their vaginal microorganisms (do not mention the past History issues). Group B: HPV negative in the past 12 months, taking the vaginal microorganisms.

Brief summary: Since other genital infections enhance HIV susceptibility by inducing inflammation, the investigators study the relationship between the vaginal microbiota composition and the risk of HPV infection, cervical cytological abnormalities.

Detailed description: Persistent infection with oncogenic Human Papillomavirus (HPV) is necessary but not sufficient for the development of cervical cancer. Additional factors correlated with HPV persistence include immunodeficiency caused by HIV, smoking, use of oral contraceptives and, more recently reported, vaginal dysbiosis. In a state of dysbiosis, there is a marked reduction of Lactobacillus and a high diversity of bacteria, with increased abundance of anaerobic bacterial species. Based on this, the investigators are going to analyze the changes of microbiota in women with high-risk HPV and the cervical lesions. And the investigators hope to figure out the difference and change in microbiota to realize the tanning of cervical lesions.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of HR-HPV results.

Exclusion Criteria:

Clinical diagnosis of vaginitis, immune disease, malignancy History of cervical lesions Pregnancy Clinical diagnosis of other serious systemic primary diseases, such as severe liver and kidney dysfunction Severe mental illness

Primary outcomes:
measure: Vaginal microbiota and HR-HPV infection
timeFrame: 12 months
measure: Vaginal microbiota and the cervical lesion
timeFrame: 12 to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02898740: Telephone-linked Home-based Exercise Training in PD
Official title: Telephone-linked Home-based Exercise Training in PD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
exercise therapy
quality of life
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-09-13
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This project is investigating whether a home-based exercise program will reduce depression in patients with Parkinson's disease.

Detailed description: Background/Rationale:

Nonmotor symptoms in Parkinson's disease (PD) are thought to be present from the early stages of disease and are often more disabling and resistant to treatment than motor symptoms. One of the most important and serious of these symptoms is depression. However, there is no consensus on best pharmacological treatment for depression in PD as efficacy is lacking and there is much concern about polypharmacy and safety of various antidepressant medications. Therefore, it is essential that the investigators characterize the effects of nonpharmacological interventions on depression in PD. A number of studies have shown significant benefits of exercise in reducing depressive symptoms. Emerging studies indicate similar benefits of exercise in the form of resistance training in limiting depression in older adults as well as in those with PD.

Objective:

The investigators hypothesize that a home-based exercise intervention will reduce depression in Veterans with depression in PD.

Methods:

The proposed study is a randomized, controlled trial of a structured exercise intervention, evaluating effects on depression. Community-dwelling Veterans with depression in PD will be randomized to the exercise intervention or a health education control intervention. Participants will be male and female Veterans with a physician diagnosis of idiopathic, typical PD, with at least 2 of 3 cardinal signs of PD, response to dopaminergic medication, and depression. The interventions will last 6 months.

Eligibility criteria: Inclusion Criteria:

* Physician diagnosis of idiopathic, typical Parkinson's disease (PD)
* At least 2 of 3 cardial signs of PD
* Response to dopaminergic medication
* Depression

Exclusion Criteria:

* Angina pectoris
* History of myocardial infarction within 6 months
* History of ventricular dysrhythmia requiring current therapy

Primary outcomes:
measure: Change in Hamilton Rating Scale for Depression (HAM-D) From Baseline to 6 Months
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: David W Sparrow, DSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04974840: Thera-band Resisted Treadmill Training for Chronic Stroke Patients
Official title: Effects of Thera-band Resisted Treadmill Training on Walking Ability in Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Stroke
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if treadmill training combined with thera-band resistance to body support and forward propulsion would be more effective than treadmill training alone in improving over-ground walking ability and reducing energy cost in chronic stroke patients. This study will also characterize the neuromuscular and kinematic strategies to adapt to resisted treadmill walking in non-impaired adults and stroke patients.

Detailed description: This study includes chronic stroke patients who will be randomly assigned to treadmill training combined with thera-band or treadmill training alone group to receive 30 min per session, 2 sessions per week for 8 weeks walking training . Functional balance (Berg Balance Scale), gait characteristics during preferred and maximal speed level walking, and oxygen uptake during 5-minute bouts of treadmill walking will be assessed before and after training and at 2-month follow-up. Clinical sensorimotor function assessment, including hand grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and Fugl-Meyer lower extremity motor scale will also be conducted for subject characterization.

Eligibility criteria: Inclusion Criteria:

1. the diagnosis of first time unilateral stroke more than 6 months before
2. the ability to walk for at least 15 m without person assistance
3. apparent gait deficits upon visual inspection by a trained physical therapist or inability in community ambulation, i.e. walking speed \< 0.8 m/s
4. resting blood pressure lower than 150/90 mmHg.

Exclusion Criteria:

1. older than 75 years
2. inability to follow the experimental instructions or procedures
3. any pain, inflammation, or other conditions that could affect walking
4. medically unstable.

Primary outcomes:
measure: stride characteristics
timeFrame: 8 weeks
measure: Walking oxygen uptake
timeFrame: 8 weeks
measure: Balance
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
References:
Clinical trial NCT02363140: Magnetic Resonance Imaging to Assess Changes in Meniscus Vascularity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meniscus Tears
Keywords: Musculoskeletal System
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2015-02-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The menisci in the knee joint are important for normal functioning of the knee. Meniscus tears are amongst the commonest of injuries to the knee. The pattern and blood supply of the meniscus tears determines the treatment plan and outcome. The surgeon identifies the blood supply to the meniscus tear area during the arthroscopy(key hole operation) and decides the treatment option ie repair versus partial meniscectomy.

This study aims to identify any changes that occur in the meniscus blood supply. The following are the main aims of the 'MOVE'study-

1. Use of non-invasive methods ie MRImaging to assess meniscus vascularity to preoperatively plan treatment and advice patient on recovery.
2. The study would assess changes in meniscus blood supply depending on age of the patient.
3. The study aims to assess the alteration in meniscus blood supply following an arthroscopic(key hole) meniscal repair operation.


Eligibility criteria: Inclusion Criteria:

Inclusion criteria for Group I,II

1. Patients should be aged 18-20 years or 35-45years
2. Asymptomatic knee for past 6 months.
3. Painless flexion-extension movements at knee joint.

Inclusion criteria for Group III

1. Patients should be aged 75 or older
2. Knee X-ray showing no more than Kellgren-Lawrence grade II osteoarthrtis
3. No clinical suspicion of meniscus tear
4. Painless flexion-extension movements at knee joint.

Inclusion criteria for Group IV

1. Patients should have presented with clinical signs to suggest meniscus tear indicating potential need for surgical meniscus repair.

Exclusion Criteria:

1. Proven Polyarthritis / Polyarthralgia secondary to Rheumatoid arthritis, Gout, Lupus, Ankylosing Spondylosis, Psoriatic arthritis
2. Any previous surgical procedure(open or arthroscopic) involving the knee joint.(baring the current meniscus repair in Group IV participants)
3. Patients unable to give informed consent.
4. Patients with contraindication for MR Imaging - Metal implants, prosthetic heart valves, pacemakers, metal foreign bodies, VP shunts, pregnancy, cochlear implant, metal clips in the brain, Patients with static tremor i.e. Parkinson's disease.
5. Patients with contraindications for contrast agent - Renal impairment, Previous allergic reaction.

Primary outcomes:
measure: Primary outcome is to assess meniscus vascularity in-vivo by use of MR imaging technique.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06330740: Evaluations of CDS Systems
Official title: Reducing Medication Ordering Errors Through Indications-Based Prescribing
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Safety Issues
Keywords: medication safety
patient safety
Lead sponsor: New York Presbyterian Hospital
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 2000
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: Indications-based prescribing is a medication ordering system in which a clinician selects an indication, and then the electronic health record (EHR) suggests an appropriate medication regimen. This approach was shown to significantly decrease medication ordering errors in a prototype environment. However, the effect of indications-based prescribing on preventing ordering errors has not been rigorously evaluated in a real-world healthcare setting. Antibiotics are the medication class most likely to contain ordering errors, which can lead to significant patient harm. At NewYork-Presbyterian (NYP) a robust antimicrobial indication-based order set was developed to help clinicians identify the appropriate antibiotic, dose, frequency, and duration, based on type of infection and patient-specific characteristics, but it is not widely used. The investigators propose a randomized controlled trial to assess the effectiveness of this indications-based order set for reducing antimicrobial ordering errors.


Eligibility criteria: Inclusion Criteria:

All providers placing inpatient orders on adult patients.

Exclusion Criteria:

Providers placing orders on patients who were ordered for antibiotics \>24 hours in the past 72 hours and/or patients with positive cultures during that admission, and/or placing an order from the order set.

Primary outcomes:
measure: The combined rate of Wrong Drug, Wrong Duration, Wrong Dose and Wrong Frequency Retract-And-Reorder (RAR) events will be combined to create an overall rate of near-miss ordering errors in the control and intervention arm.
timeFrame: Up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02881840: Mass-balance Study of [14C]-APD421 in Healthy Volunteers
Official title: An Open Label, Single Dose, Single Period Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C] APD421 Administered Via the Intravenous Route to Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Post-operative Nausea and Vomiting
Lead sponsor: Acacia Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2016-08-29
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open-label, non-randomised, single dose study in 6 healthy male subjects to assess the mass balance recovery, metabolite profile, metabolite identification and pharmacokinetics of 14C-labelled APD421


Eligibility criteria: Inclusion Criteria:

* Healthy males
* Age 18 to 65 years of age at time of signing informed consent
* Body mass index (BMI) of 18 to 30 kg/m2 or, if outside the range, considered not clinically significant by the investigator
* Must be willing and able to communicate and participate in the whole study
* Must provide written informed consent
* Must agree to use an adequate method of contraception (as defined in Section 8.4)
* Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)

Exclusion Criteria:

* Prior participation in another study with a radiation burden of \> 0.1 mSv and ≤ 1 mSv in the period of 1 year prior to screening; a radiation burden of \> 1 mSv and ≤ 2 mSv in the period of 2 years prior to screening; a radiation burden of \> 2 mSv and ≤ 3 mSv in the period of 3 years prior to screening, etc (add 1 year per 1 mSv)

Primary outcomes:
measure: Mass Balance
timeFrame: 168 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences
Study officials:
affiliation: Acacia Pharma Ltd
name: Gabriel Fox, MB BChir
role: STUDY_DIRECTOR
References:
citation: Fox GM, Roffel AF, Hartstra J, Bussian LA, van Marle SP. Metabolism and Excretion of Intravenous, Radio-Labeled Amisulpride in Healthy, Adult Volunteers. Clin Pharmacol. 2019 Dec 2;11:161-169. doi: 10.2147/CPAA.S234256. eCollection 2019.
Clinical trial NCT05546840: Reporting Usual Physiotherapy Care in Stroke Survivors in Catalonia
Official title: Reporting Usual Physiotherapy Care in Stroke Survivors in Catalonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: stroke
Physiotherapy
rehabilitation
catalonia
usual care
Lead sponsor: Universitat de Lleida
Sponsor class: OTHER
Collaborators: name: Universitat Internacional de Catalunya
First posted: 2022-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physiotherapists specialized in neurorehabilitation who in their day to day care for patients with stroke.

Brief summary: Stroke is one of the major leading causes of death and disability globally and presents a high interest of research around all its branches, including rehabilitation. There are published recommendations and clinical guidelines to guide the care of stroke patients with regard to physical therapy. However, the status of current clinical practice is unknown.

This study aims to identify and describe the therapeutic approaches most used by physiotherapists in Catalonia in the care of stroke survivors in different phases of evolution.

An observational study will be carried out through an anonymous survey of physiotherapists in Catalonia. Through the College of Physiotherapists of Catalonia, all members will be invited to answer a survey on current clinical practice in the care of stroke survivors. The survey will collect data related to the physiotherapist's training and experience, the most frequently used therapeutic approaches, user profiles and institutions. It is intended to collect the data between October 2022 and February 2023. The data will be analyzed by the team of researchers


Eligibility criteria: Inclusion Criteria:

* Physiotherapists who are currently working in Catalonia with patients who have suffered a stroke.

Exclusion Criteria:

* Physiotherapists do not currently work with at least one stroke patient

Primary outcomes:
measure: Demographic data
timeFrame: Day 1
measure: Specific formation in neurology
timeFrame: Day 1
measure: Neurorehabilitation experience
timeFrame: Day 1
measure: Multidisciplinary team
timeFrame: Day 1
measure: Therapeutic intervention
timeFrame: Day 1
measure: Individual therapy
timeFrame: Day 1
measure: Group Therapy
timeFrame: Day 1
measure: Therapy
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: University of Lleida
Study officials:
References: