louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04643327: Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease
Official title: Double-blind Randomised-controlled Within-subject Crossover Trial to Determine Levetiracetam Efficacy for Memory Impairment in Parkinson's Disease: A Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Parkinson Disease
Mild Cognitive Impairment
Memory Impairment
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: Queensland University of Technology
name: Johns Hopkins University
name: Cleveland Clinic Lou Ruvo Center for Brain Health
name: Royal Brisbane and Women's Hospital
First posted: 2020-11-25
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blind randomised-controlled within-subject crossover trial
Primary purpose: TREATMENT

Brief summary: The present study is a proof-of-concept clinical trial to test the efficacy of low doses of a repurposed anti-epileptic drug (levetiracetam) in treating memory problems in Parkinson's disease (PD). Neuroimaging techniques will be used to determine the effect of the drug on specific brain regions (hippocampal subfields). Finally, baseline brain activity of PD patients with memory problems will be compared to PD patients without memory problems and healthy older adults to determine if activity in specific brain regions (hippocampal subfields) can be used to predict memory problems in PD. This information will be useful for future clinical trials to target drugs to these brain regions.


Eligibility criteria: Inclusion Criteria:

* Parkinson's Disease patients with amnestic Mild Cognitive Impairment
* Parkinson's Disease patients with no memory impairment
* Healthy volunteers
* All participants must be eligible to take MRI scans

Exclusion Criteria:

* Dementia
* Contraindication to having MRI
* Bipolar disorder, Schizophrenia, Alcohol or substance abuse
* Major depression
* Suicidal Ideation
* Difficulty complying with protocol requirements
* Significant non-PD neurological disease
* Vascular dementia
* Sensitivity to levetiracetam
* Use of anticonvulsant medications
* Use of other excluded medications
* Severe renal impairment
* Clinically significant abnormalities in B12 or thyroid function test (below normative range for elderly)
* Females of childbearing potential

Primary outcomes:
measure: Pattern separation performance (behavioural outcome)
timeFrame: Immediately after 2 weeks of treatment
measure: Hippocampal DG/CA3 subfield activity
timeFrame: Immediately after 2 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: University of Queensland Centre for Clinical Research
state: Queensland
Study officials:
References:
Clinical trial NCT04879927: Routine Evaluation of the Social Determinants of Health in Oncology: User-centered Resource Coordination and Engagement
Official title: Routine Evaluation of the Social Determinants of Health in Oncology: User-centered Resource Coordination and Engagement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lung Cancer
Gastrointestinal Cancer
Keywords: Breast Cancer
Lung Cancer
Gastrointestinal Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this research is to understand how screening for patient resource needs followed by customized resource matching can improve outcomes for adults with breast, lung or gastrointestinal cancer.

Detailed description: This research study is an intervention assessment; this is the first-time investigators are examining the impact of screening for resource needs followed by customized resource matching at Dana-Farber Cancer Institute.

* The research study procedures include screening for social determinants of health (resource) needs and, depending on study group, resource matching.
* Participants will be randomized into one of two groups.

  * Usual Care or Usual Care with customized resource matching.

It is expected that about 125 participants will take part in this research study.

Eligibility criteria: Inclusion Criteria:

* Eligible patients will be adults age 18 or older, able to consent, scheduled for a new patient consultation in DFCI BOC, TOP or GCC. To select for patients from demographic groups vulnerable to SDoH needs, two different groups will be eligible to participate.
* Group A

  * BIPOC (Black, Latinx, Native American or Pacific Islander)
  * LEP Spanish-speaking (As indicated by the EHR)
  * Low SES (from zip code with median household income \<$32,000/year) OR
  * Age 70+
* Group B

  * Any one NPIQ response indicating SDoH need
  * Health literacy/numeracy, Caregiving/relationships, OR Finances

Exclusion Criteria:

- Group A and B

-- Patients not continuing care at Dana Farber Cancer Institute

Primary outcomes:
measure: Number of Patients Treatment Interruption
timeFrame: 30 Days
measure: Number of Patients Treatment Interruption
timeFrame: 90 Days
measure: Number of Patients Treatment Interruption
timeFrame: 180 Days
measure: Rate of Treatment Interruption
timeFrame: 00 Days
measure: Rate of Treatment Interruption
timeFrame: 90 Days
measure: Rate of Treatment Interruption
timeFrame: 180 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Nadine J. McCleary, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01007227: Metabolic Syndrome and Fingertip Endothelial Dysfunction
Official title: Achievement of Dietetic and Exercise Therapy Evaluated by Self-assessment Score Significantly Improved Endothelial Dysfunction in Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Kumamoto University
Sponsor class: OTHER
First posted: 2009-11-03
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Life-style intervention with dietetic and exercise therapy is an important fundamental approach to patients with metabolic syndrome (MetSyd) which may cause endothelial dysfunction leading to cardiovascular events. We investigated whether the life-style modification by dietetic and exercise instruction could improve endothelial dysfunction assessed by a new non-invasive and automatic device; digital reactive hyperemia peripheral arterial tonometry (RH-PAT).

Detailed description: Outline of methods RH-PAT was measured in high-risk patients under 70 years old. The MetSyd was defined according to guidelines of the National Cholesterol Education Program Third Adult Treatment Panel (NCEP - ATP III). We instructed all MetSyd patients about the dietetic and exercise therapy according to the Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases. we conducted a questionnaire survey of the self-assessment for dietetic and exercise instruction program, respectively.

Eligibility criteria: Inclusion Criteria:

* Under 70 years old and preserved left ventricular systolic function (left ventricular ejection fraction ≥ 50%)

Exclusion Criteria:

* Severe valvular heart disease
* Atrial septal defect
* Myocarditis
* Cardiomyopathy
* Active inflammatory diseases
* Pulmonary hypertension
* Chronic kidney disease on hemodialysis
* Advanced hepatic disease
* Leukemia
* Schizophrenia; AND
* Cerebrovascular disease and residual hemiplegia.

Primary outcomes:
measure: Endothelial function assessed by RH-PAT
timeFrame: About 1 year later
Secondary outcomes:
measure: Metabolic status including waist circumference
timeFrame: About 1 year later
Other outcomes:
Locations:
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
Study officials:
References:
Clinical trial NCT06217627: Skin Rejuvenation Using Stem Cell Secretome
Official title: The Potential of Umbilical Cord Stem Cell Secretions in Skin Rejuvenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Skin Rejuvenation
Lead sponsor: COR clinic of Regenerative Medicine
Sponsor class: NETWORK
First posted: 2024-01-22
Enrollment: 49
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial aims to investigate the effect of umbilical cord explants (UC)-explants and UC-mesenchymal stem cells (MSCs) secretome on skin rejuvenation, to provide future reference or standard in the application of cell free-based therapy in skin aging.

Detailed description: This trial is a pilot clinical trial evaluating the effect of the secretions of umbilical cord explants and mesenchymal stem cells on skin rejuvenation. Also the concentration of selected growth factors was assessed in the secretome derived from UC-explants and UC-MSCs.

Healthy women participants, after their consent, received secretome injections in their hands, face, and neck. Outcomes were assessed on the Hand Volume Rating Scale, Wrinkle Severity Rating Scale, and through histologic examination of skin biopsy at two different times: before treatment and after 12 months. A digital camera was used to obtain photographs of hands, face, and Neck at each visit. These were assessed by a single-blinded dermatologist. SPSS software version 26 (64-bit) was used for all analyses.

Participants provided written informed consent and were asked not to change their routine skin care habits during the study.

Eligibility criteria: Inclusion Criteria:

* women participants aged \> 25 years
* any skin type according to the Glogau scale
* Willing to be a research subject, sign a consent form, and commit to follow-up visits

Exclusion Criteria:

* patients with active skin diseases (e.g. atopic dermatitis, psoriasis, rosacea, seborrheic dermatitis)
* patients using other anti-aging treatments within 1 month

Primary outcomes:
measure: Selected growth factors assessment
timeFrame: 4 samples of secretome extracted from UC-explants with one week interval. 1 sample of secretome extracted from confluent UC-MSCs at passage 1
measure: Wrinkle severity in hands
timeFrame: digital photographs before injection and after 7 months.
measure: Wrinkle severity in the face and neck
timeFrame: digital photographs before injection and after 7 months.
Secondary outcomes:
measure: Histological examination
timeFrame: skin biopsies were performed at two moments: before treatment and after 12 months.
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: COR clinic of Regenerative Medicine
Study officials:
affiliation: COR clinic of Regenerative Medicine
name: Nada Alaaeddine, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02754427: Pilot Study for a Prospective Surveillance Program for Rehabilitation Following Surgery for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Surveillance
Physiotherapy
Arm morbidity
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 41
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Breast cancer treatment often results in long-term arm morbidity. A prospective surveillance model with arm assessment pre-surgery followed by ongoing surveillance and targeted physiotherapy treatment after breast cancer surgery may improve early detection and management of arm morbidity. This study aims to determine the effect of prospective surveillance to target physiotherapy on the prevalence of arm morbidity in the surveillance group compared to control group at 12-months after breast cancer surgery.


Eligibility criteria: Inclusion Criteria:

* age 30-75 years; receiving surgery for breast cancer, including those who will have immediate breast reconstruction.

Exclusion Criteria:

* prior breast cancer surgery; a pre-existing shoulder pathology on the side of breast surgery that limits shoulder range of motion \<75% of non-affected side; or a diagnosis of primary lymphedema

Primary outcomes:
measure: Number of Participants With Arm Morbidity at 12 Months Post-surgery - Shoulder Mobility
timeFrame: 12 months
measure: Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Muscle Strength
timeFrame: 12 months
measure: Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Function
timeFrame: 12 months
measure: Number of Participants With Arm Morbidity at 12 Months Post-surgery - Arm Volume
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: kristin.campbell@ubc.ca
name: Kristin Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05158127: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Skin Ulcer
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Skin Ulcer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Skin Ulcer
Keywords: Skin Ulcer
stem cell treatment
Lead sponsor: The Foundation for Orthopaedics and Regenerative Medicine
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will study the safety and efficacy of intravenous infusion and intralesional injection of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Skin Ulcer

Detailed description: This patient funded trial aims to study the safety and efficacy of intravenous infusion and intralesional injection of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Skin Ulcer. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Skin Ulcer
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur

Primary outcomes:
measure: Safety (adverse events)
timeFrame: Four year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: St. John's
country: Antigua and Barbuda
facility: Medical Surgical Associates Center
Study officials:
affiliation: The Foundation for Orthopaedics and Regenerative Medicine
name: Chadwick Prodromos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06209827: Effectiveness of a Community Intervention in the Chronic Use of Benzodiazepines: (BENZOSTOPJUNTOS)
Official title: Effectiveness of a Multidisciplinary Intervention in the Reduction of Benzodiazepine Prescriptions: A Cluster Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inappropriate Prescribing
Keywords: Benzodiazepine
Medication overuse.
Inappropriate Prescribing
Lead sponsor: Andalusian Health Service
Sponsor class: OTHER_GOV
Collaborators: name: Andalusian School of Public Health
First posted: 2024-01-18
Enrollment: 472
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster-randomized, parallel-group trial in which health centres were the units of randomization and patients were the units of analysis
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aimed to assess the effectiveness of a comprehensive, multicomponent intervention utilizing education and support for Benzodiazepines withdrawal compared to standard care.

Detailed description: The excessive use of benzodiazepines (BZDs) presents significant health concerns and high healthcare costs, particularly in Spain, where usage rates are among the highest globally. In Andalusian, over a 10% of the population use BZDs long-term, prompting the need for safe and effective reduction strategies.

This study aimed to assess the effectiveness of a comprehensive, multicomponent intervention utilizing education and support for BZD withdrawal compared to standard care.

The intervention involved educational discussions, consultations with health professionals, and letters supported by multiple scientific societies.

Eligibility criteria: Inclusion Criteria:

* users of health centre's with more than 4 weeks of benzodiazepines use.
* users of health centre's over 18 years of age.

Exclusion Criteria:

* users of health centre's with mental disorder.
* users of health centre's terminal.
* users of health centre's with alcohol dependence.
* users of health centre's with dementia.
* users of health centre's who had intellectual disabilities.
* users of health centre's unable to cooperate with the questionnaires.

Primary outcomes:
measure: Number of dispensing of benzodiazepines.
timeFrame: 3.5 years
Secondary outcomes:
measure: Knowledge
timeFrame: 6 months
measure: Life Quality
timeFrame: 6 months
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Ingrid Ferrer López
Study officials:
affiliation: SAS
name: Ingrid Ferrer López, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02460627: Topical Lidocaine After Arthroscopy on Knee
Official title: Postoperative Pain Management With Topical Lidocaine After Arthroscopy on Knee. A Randomized Double-blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Postoperative Pain
Topical Anaesthesia
Keywords: Arthroscopy
Meniscus
Lidocaine
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: More than half of the patients suffer from intensive pain 1-2 days after arthroscopy in the knee. Walking function and physical activities are affected by this intensive pain although local anaesthetic is given in the joint and soft tissue.

The patients are often discharged on the same day as the arthroscopy takes place depending on their ability to walk with or without assistive technology.

It is a well-known fact that the patient is given a dose of morphine, analgesics or an ice pack on a painful knee to reduce pain intensity. The aim of the project is to study whether pain intensity and analgesics can be additionally reduced by giving local anaesthetic by means of an adhesive tape placed on the skin instead of giving morphine, analgesics or ice pack on a painful knee.

The researchers plan to include a cohort of 180 patients: 60 patients having a meniscus sutured, 60 patients having meniscus tissue removed surgically, 60 patients having mucous fold removed surgically.

This study is planned to be a pilot study in order to complete a future large medical science study.


Eligibility criteria: Inclusion Criteria:

* Planned resection of meniscus (DS832, DM232)
* Planned meniscus suture (DS832)
* Planned plica resection (DM659)
* Patients \>=18 years and \<50 years
* Statement of consent
* Tolerance to Lidocaine (analgesics)

Exclusion Criteria:

* Type 1 diabetes or type 2 diabetes
* Allergic to Lidocaine (analgesics)
* Heart disease, liver disease, kidney disease
* BMI \>=35
* Unability to read or speak Danish
* Rheumatoid arthritis or other degenerative diseases in joint, bone structure or cartilage
* Insufficient coagulation
* Medication of morphine pre-operatively
* Pregnant and nursing women

Primary outcomes:
measure: Administration of analgesics or morphine in time
timeFrame: 1 day
Secondary outcomes:
measure: Discharges of patients in time
timeFrame: 1 day
measure: Value Added Score (VAS) estimation of pain
timeFrame: 1 day
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: Region of Northern Jutland
Study officials:
References:
Clinical trial NCT02671227: Intrathecal Mg in Gynecologic Laparoscopic Surgeries.
Official title: Effects of Addition of Magnesium Sulfate in Spinal Anesthesia on Surgeon Satisfaction and Postoperative Pain in Gynecologic Laparoscopic Surgeries.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gynecologic Laparoscopic Surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aim to investigate the differences between intrathecal Bupivacaine + Mg sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction and postoperative pain in gynecologic laparoscopic surgeries.

Detailed description: The investigators aim to investigate the differences between intrathecal Bupivacaine + Mg sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction, patient satisfaction and postoperative pain in gynecologic laparoscopic surgeries.

Eligibility criteria: Inclusion Criteria:

* female patient.
* more than 18 years.
* undergoing elective gynecologic laparoscopic surgeries.

Exclusion Criteria:

* allergy to local anesthesia.
* contraindication to spinal anesthesia.
* Significant cardiac, liver or renal dysfunction.
* Inability to informed consent

Primary outcomes:
measure: surgeon satisfaction (scale from 1 to 10) .
timeFrame: intraoperative (from beginning of the gynecologic laparoscopic procedure till the end of the procedure).
Secondary outcomes:
measure: postoperative pain management (VAS score).
timeFrame: postoperative for 6 hours.
Other outcomes:
Locations:
city: Asiut
country: Egypt
facility: Asiut university hospital
Study officials:
References: