louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02274675: A Pilot Study of Robot-assisted Therapy for Post-stroke Forearm and Wrist Rehabilitation Training
Official title: A Pilot Study of Robot-assisted Therapy for Post-stroke Forearm and Wrist Rehabilitation Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Keywords: Stroke
Robot-assisted therapy
Rehabilitation
Lead sponsor: Universiti Teknologi Malaysia
Sponsor class: OTHER
Collaborators: name: National Stroke Association of Malaysia (NASAM)
name: Collaborative Research in Engineering, Science and Technology Center (CREST)
name: Ministry of Higher Education (Lab2Market)
First posted: 2014-10-24
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A pilot study to assess the effectiveness of CR2-Haptic and determine the feasibility of including robotic therapy into the daily rehabilitation program.

Detailed description: The objective of this study is to clinically assess the effectiveness of CR2-Haptic and determine the feasibility of including robotic therapy into the daily rehabilitation program, and investigate the acceptance from patients and therapists. Total of 7 patients will be recruited in this study, all the patients will receive 1.5 hours of standard therapy together with 0.5 hour of robot therapy every day. The robot therapy will be a 30 mins long session for 3 to 5 days per week over a period of six weeks. The study will include forearm pronation-supination and wrist flexion-extension training.

Eligibility criteria: Inclusion Criteria:

* Sub-acute and chronic stroke patients
* Able to rest comfortable in training set-up
* Mini-Mental Status Examination (MMSE) Score (\>21)
* Motor Assessment Scale (Balance sitting \>3)
* Modified Ashworth Scale (Wrist \< 2)

Exclusion Criteria:

* Contractures in affected upper extremity which inhibit movements being tested

Primary outcomes:
measure: Motor Impairment of Wrist and Forearm
timeFrame: Motor impairment of wrist and forearm at week 6
Secondary outcomes:
measure: Motor Function Assessment of Hand Movement
timeFrame: Motor function of hand function at week 6
measure: Spasticity Level of Wrist
timeFrame: Spasticity level of wrist at week 6
measure: Forearm's Active Range of Movement
timeFrame: Active range of motion of forearm at week 6
measure: Forearm's Passive Range of Motion
timeFrame: Passive range of motion of forearm at week 6
measure: Wrist's Passive Range of Motion
timeFrame: Passive range of motion of wrist at week 6
measure: Wrist's Active Range of Motion
timeFrame: Active range of motion of wrist at week 6
Other outcomes:
Locations:
city: Petaling Jaya
country: Malaysia
facility: National Stroke Association of Malaysia (NASAM)
state: Kuala Lumpur
Study officials:
affiliation: Universiti Teknologi Malaysia
name: Yeong C Fai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00224575: Reassessment Strategy in the Diagnosis of Coronary Heart Disease in Elderly
Official title: Therapeutical Impact of a Reassessment Strategy in the Diagnosis of Coronary Heart Disease in Elderly
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Myocardial Ischemia
Keywords: Veterans
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-09-23
Enrollment: 260
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Despite the effectiveness of beta-blockers and antiplatelet agents for secondary prevention of coronary heart disease, this treatments are underused in the elderly because of diagnosis uncertainty and underuse of efficient treatment.

in a first time, diagnosis reassessment with invasive technique if necessary. in a second time, treatment reassessment.

Detailed description: not desired

Eligibility criteria: Inclusion Criteria:

* patients 75 of age or older hospitalized in a geriatric service and suspect of coronary heart disease

Exclusion Criteria:

* acute myocardial infarction

Primary outcomes:
measure: therapeutical impact of a reassessment strategy in the diagnosis of coronary heart disease in elderly
timeFrame: during hospitalization
Secondary outcomes:
measure: part link, in the treatment modification, with diagnosis reassessment and the part link with treatment optimization, death and rehospitalization in the subsequent 6 and 12 months
timeFrame: during hospitalization
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Bichat
Study officials:
affiliation: APHP
name: legrain sylvie
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01752075: A Non-interventional, Observational Post-marketing Registry of Patients Treated With Revlimid (Lenalidomide) in Taiwan
Official title: A Non-interventional, Observational Post-marketing Registry of Patients Treated With Revlimid (Lenalidomide) in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Multiple myeloma
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2012-12-19
Enrollment: 100
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: Taiwanese patients with relapsed/refractory multiple myeloma

Brief summary: The REVLIMID Registry will provide safety data from a large cohort of Taiwanese patients treated with REVLIMID. In addition, the registry will provide efficacy data and outcomes in a real-world setting (versus a clinical trial).

Detailed description: The REVLIMID Registry is a prospective, multi-center, observational study. The registry will register 100 patients being prescribed REVLIMID in Taiwan during and patients will be followed for two years after the enrollment of the last patient.

Safety and efficacy data will be recorded in the registry monthly or bi-monthly. In accordance with the Risk Minimization Program for REVLIMID (RevAssure) a patient categorized as a woman of childbearing potential will be prescribed REVLIMID on a monthly basis, whereas women of non-childbearing potential and men will be allowed up to two months supply per prescription.

After entry of baseline data, the prescribing physician should prescribe and monitor REVLIMID therapy according to the guidance and recommended schedules given in the approved Taiwan package insert (PI)

Eligibility criteria: Inclusion Criteria:

* Adult patients 18 years of age or older
* Patients that are being prescribed REVLIMID in combination with dexamethasone for the treatment of multiple myeloma and that have received at least one prior therapy
* Patient must be willing and able to provide informed consent
* Patients will be informed about the Registry and will have to sign a specific Registry Informed Consent Form
* Be able to ask questions prior to signing the Subject Information and Consent Form
* Be clearly informed that their involvement/participation in the registry is voluntary
* Understand that their medical care will not be altered in any way by their participation in the registry

Exclusion Criteria:

- A Patient who is unwilling or unable to provide informed consent will not be included.

Primary outcomes:
measure: Adverse Events
timeFrame: Up to two years
Secondary outcomes:
measure: Efficacy
timeFrame: Up to two years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: NTUH
Study officials:
affiliation: Celgene
name: Ye Hua, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03890575: Airway Segmented Stent Modified With 3D Printing for Malignant Stricture Involving Carina and Distal Bronchi
Official title: Covered Metallic Segmented Airway Stent Modified With 3D Printing for Malignant Stricture Involving Carina and Bronchi Distal to Carina: A Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stricture; Trachea
Malignant Neoplasm
Keywords: 3D printed
airway stent
carina
distal bronchi
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Pulmonary Hospital, Shanghai, China
name: Shanghai Tong Ren Hospital
name: Ruijin Hospital Luwan Branch
First posted: 2019-03-26
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, we used the covered metallic segmented airway stent to treat malignant strictures involving carina and bronchi distal to carina and aimed to determine the feasibility, efficacy and safety of this technique.


Eligibility criteria: Inclusion Criteria:

* Patients with malignant stricture involving carina and bronchi distal to carina based on the diagnosis by bronchoscopy or CT.

Exclusion Criteria:

* Severe infection
* Coagulation disorders

Primary outcomes:
measure: Improvement in Dyspnea using Hugh-Jones classication as criteria
timeFrame: 3 days
measure: Stent patency time
timeFrame: 2 months
measure: Overall survival
timeFrame: 6 months
Secondary outcomes:
measure: Number of participants with adverse events that are related to stent implantation
timeFrame: 2 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Luwan Branch
city: Shanghai
country: China
facility: Shanghai Tongren Hospital
Study officials:
affiliation: Ruijin Hospital
name: Zhongmin Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04398875: Adjunctive Effect of Acupuncture for Advanced Cancer Patients With Palliative Care: a Three-arm Randomized Trial
Official title: The Adjunctive Effect of Acupuncture for Advanced Cancer Patients in a Collaborative Model of Palliative Care: a Three-arm Pragmatic Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Advanced Cancer
Keywords: advanced cancer
palliative care
acupuncture
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 120
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: The proposed study aims to evaluate the adjunctive effect of MA with standard care (ASC) for relieving cancer-related symptoms in a collaborative model of palliative care compared to sham MA plus standard care (SSC) or standard care alone (SC).

Detailed description: After being informed about the study plan, potential risk and benefits, all subjects will give written informed consent prior to participation and undergo eligibility screening. Eligible participants will be randomized into three arms, ASC, SSC, and SC, in a 2:1:1 ratio.

Eligibility criteria: Inclusion Criteria:

* All cases are subject to pathology and (or) cytology for a diagnosis of malignant tumour (pathological type is not restricted) at stage IIIB or IV;
* Aged 18 years or above;
* Expected survival time longer than 16 weeks;

Exclusion Criteria:

* Disseminated intravascular coagulation or severe thrombocytopenia with a bleeding tendency, i.e., low platelet count \< 35000/µL; INR \> 1.5; hemoglobin ≤ 90 g/dL; white blood cell count ≤ 4x109/L;
* Uncontrolled active skin infection;
* Needle phobia;
* Inability to read and understand Chinese;
* Not signed written informed consent.
* Receiving surgery during the whole study period;
* Receiving acupuncture treatment in the last 3 months

Primary outcomes:
measure: Change of the symptom improvments
timeFrame: Change from baseline score at 3 weeks
Secondary outcomes:
measure: EORTC QLQ-C15-PAL
timeFrame: weeks 0, 3, 7 and 11
measure: Numeric Rating Scale
timeFrame: weeks 0, 3, 7 and 11
measure: Fatigue
timeFrame: weeks 0, 3, 7 and 11
measure: The Hospital Anxiety and Depression Scale
timeFrame: weeks 0, 3, 7 and 11
measure: The Insomnia Severity Index
timeFrame: weeks 0, 3, 7 and 11
measure: Symptom improvments
timeFrame: weeks 0, 1, 2, 7 and 11
Other outcomes:
Locations:
Study officials:
affiliation: The University of Hong Kong
name: Haiyong CHEN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen H, So TH, Cho WC, Qin Z, Ma CH, Li SG, Yang Z, Jiang F, Wu J, Zhang ZJ, Kong FM, Lao L. The Adjunctive Effect of Acupuncture for Advanced Cancer Patients in a Collaborative Model of Palliative Care: Study Protocol for a 3-Arm Randomized Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211012749. doi: 10.1177/15347354211012749.
Clinical trial NCT01443975: Clinical Evaluation on the Use of the X-pander Device
Official title: Clinical Evaluation on the Use of the X-pander Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthrosis
Total Hip Arthroplasty
Keywords: Total Hip Arthroplasty
Osteoarthritis
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
Collaborators: name: Company Medichanical Engineering
First posted: 2011-09-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients for primary THA

Brief summary: The purpose of this study is to clinically evaluate the use of the x-pander device.

Detailed description: Clinical evaluation on the use of the x-pander device during THA-surgery

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis for hip osteoarthrosis

Exclusion Criteria:

* Previous surgery of the actual hip

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Farsoe Hospital, Aalborg University Hospital
country: Denmark
facility: Ortopaedic Clinic
city: Frederikshavn Hospital, Aalborg University Hospital
country: Denmark
facility: Ortopaedic Clinic
Study officials:
affiliation: Orthopaedic Surgery Research Unit, Aalborg Hospital, Denmark
name: Mogens B. Laursen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06473675: Hysterectomy With Adnexal Surgery Procedures With the DEXTER Robotic System (The HYPER Study)
Official title: Hysterectomy With Adnexal Surgery Procedures With the DEXTER Robotic System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hysterectomy
Lead sponsor: Distalmotion SA
Sponsor class: INDUSTRY
Collaborators: name: confinis AG
First posted: 2024-06-25
Enrollment: 52
Sex: FEMALE
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: Adult patients undergoing a hysterectomy with adnexal surgery for benign disease.

Brief summary: This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease.


Eligibility criteria: Inclusion Criteria:

* Aged \> 18 years
* Patients planned to undergo elective robot-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease; using one camera port, two ports for the manipulating instruments, and additional ports as needed.

Exclusion Criteria:

* Morbidly obese patients (BMI \> 40)
* Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments
* Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery
* Bleeding diathesis
* Pregnancy
* Patients with pacemakers or internal defibrillators
* Any planned concomitant procedures
* Patient deprived of liberty by administrative or judicial decision.
* Participation in another interventional clinical trial

Primary outcomes:
measure: primary safety endpoint
timeFrame: up to 42 days
measure: primary performance endpoint
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Saintes
country: France
facility: Groupe Hospitalier Saintes - Saint-Jean-d'Angély
city: Baden
country: Switzerland
facility: Kantonsspital Baden
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Interlaken
country: Switzerland
facility: Spitäler FMI AG
Study officials:
References:
Clinical trial NCT03175575: Pilot Study on Community Gardens and Food Purchases in Deprived Neighborhood (Marseille, France)
Official title: A Pilot Study to Assess How Access to a Community Garden Could Help Instigate the Adoption of Healthier Food Purchase Patterns in Deprived Neighborhood (Marseille, France)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutritional Quality of Food Purchases
Lead sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Sponsor class: OTHER
Collaborators: name: National Research Agency, France
First posted: 2017-06-05
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women gardeners

Brief summary: The pilot study aims to investigate the place of fresh garden produce in the food supply and food practices of women in community gardens of deprived neighborhoods of Marseille, reputed to be among the poorest in the European Union. We hypothesized that access to a community garden in these neighborhoods could help instigate the adoption of healthier food patterns by gardeners and their households, and in particular, increase their consumption of fruits and vegetables.

Detailed description: Urban community gardening was explored in terms of (i) food production, (ii) nutrition and economics, and (iii) cultural, social, and symbolic dimensions, by social and nutritional science approaches, involving informative questionnaires, semi-structured interviews, and a nutritional and economic analysis of household food supplies.

Eligibility criteria: Inclusion Criteria:

* Having access to a community garden in deprived neighborhoods of Marseille
* Willingness to be involved in the study
* Be in charge of the household food purchases

Exclusion Criteria:

* None

Primary outcomes:
measure: Household food supply records.
timeFrame: One-month
Secondary outcomes:
measure: Informative questionnaire
timeFrame: 45 min
measure: Comprehensive interviews
timeFrame: 1 hour
Other outcomes:
Locations:
Study officials:
References:
citation: Tharrey M, Dubois C, Maillot M, Vieux F, Mejean C, Perignon M, Darmon N. Development of the Healthy Purchase Index (HPI): a scoring system to assess the nutritional quality of household food purchases. Public Health Nutr. 2019 Apr;22(5):765-775. doi: 10.1017/S1368980018003154. Epub 2018 Nov 26.
Clinical trial NCT03656575: Reduction of Pro-Inflammatory Synovial Fluid Biomarkers in Osteoarthritis of the Knee With Alpha-2 Macroglobulin
Official title: Reduction of Pro-Inflammatory Synovial Fluid Biomarkers in Osteoarthritis of the Knee With Alpha-2 Macroglobulin: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the current study is to assess the ability of alpha-2-macroglobulin treatment to reduce the level of pro-inflammatory synovial fluid biomarkers in patients with osteoarthritis of the knee.

This is a double-blinded rationalized control trial with prospective data collection. The study will collect and analyze the synovial fluid, serum, and urine of patients presenting with knee osteoarthritis in Kellegren-Lawrence grade 2 or 3. It will compare synovial fluid biomarker levels between patients receiving an intra-articular alpha-macroglobulin, intra-articular PR injection and intra-articular corticosteroid serving as a control. Pre-injection pain and function will be assessed. Post-injection pain, function and outcomes will be assessed after six weeks and three months.


Eligibility criteria: Inclusion Criteria:

* Patients osteoarthritis classified as Kellegren-Lawrence grade 2 or 3

Exclusion Criteria:

* Mentally impaired (e.g, Alzheimer's subjects, dementia, etc.)
* Younger than 18 years of age
* Greater than 90 years of age
* Patients with underlying inflammatory arthropathies

Primary outcomes:
measure: Measure of synovial fluid biomarker levels
timeFrame: 6 Weeks
measure: Measure of synovial fluid biomarker levels
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Laith Jazrawi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05477875: Cannabinoid vs Opioid for Photorefractive Keratectomy Pain Control
Official title: Randomized, Controlled Cross-over Comparison of Cannabinoid to Oral Opioid for Postoperative Photorefractive Keratectomy Pain Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Photorefractive Keratectomy
Myopia
Hyperopia
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Consortium for Medical Marijuana Clinical Outcomes Research
First posted: 2022-07-28
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Photorefractive Keratectomy (PRK) is a commonly performed corneal refractive surgery but has significant post-operative pain. Pain medications after PRK are typically opioid-acetaminophen combinations. Alternatives to opioid medication are worth consideration. Patients will receive PRK in each eye sequentially, using the cannabinoid or codeine/acetaminophen for one eye and the other treatment for the fellow eye two weeks later.


Eligibility criteria: Inclusion Criteria:

* Adults older than 18 years with refractive stability for 1 year electing to have PRK surgery
* Consenting to participate
* Not meeting exclusion criteria will be included in the study population.

Exclusion Criteria:

* Patients not candidates for PRK will be excluded from the study.
* Patients taking other pain medications for concomitant medical conditions including, but not limited to tricyclic antidepressants, gabapentin and tramadol will be excluded from the study.
* Additional exclusion criteria will be known or suspected allergy or hypersensitivity to any of the routine or study medications.
* Patients completing follow up appointments at anywhere other than UF Health Ophthalmology clinic at the Oaks will not be enrolled in the study.
* Patients who are pregnant or nursing are not eligible for PRK, and such patients are not eligible to enroll in this study. Female patients of child-bearing age will be pregnancy tested before surgery and study enrollment.
* Patients will be specifically counseled, and it will be noted in the written informed consent that use of the cannabinoid product may result in a positive THC urinalysis screening test so they may self-exclude if such a situation could cause social and/or employment conflict.

Primary outcomes:
measure: Pain as recorded by the FACES scale
timeFrame: 1 week
Secondary outcomes:
measure: Uncorrected visual acuity
timeFrame: 1 week
measure: Subjective vision questionnaire
timeFrame: 1 week
measure: Corneal haze
timeFrame: 1 week
measure: Ocular discomfort questionnaire
timeFrame: 1 week
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Oaks Eye Center
state: Florida
Study officials:
affiliation: University of Florida
name: W Steigleman, MD
role: PRINCIPAL_INVESTIGATOR
References: