louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05152381: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Osteoporosis
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Osteoporosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Osteoporosis
Keywords: Osteoporosis
stem cell treatment
Lead sponsor: The Foundation for Orthopaedics and Regenerative Medicine
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 0
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 of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Osteoporosis

Detailed description: This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Osteoporosis. Patients will receive a single intravenous infusion of UC-MSCs. 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 Osteoporosis
* 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 NCT01768481: Intima Media Thickness Regression in Dyslipidemic Teenagers
Official title: Intervention précoce Sur Les Indices d'athérogénèse Des Adolescents à Risque
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Dyslipidemia
Keywords: Obesity
Dyslipidemia
Cholesterol
Intima media thickness
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2013-01-15
Enrollment: 16
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled trial of statin intervention in dyslipidemic obese teenagers. Primary outcome is intima media thickness before and after intervention.

Detailed description: Obese teenagers with abnormal lipid profiles were randomized to either low dose statin or placebo and had their carotid intima media thickness compared before and after intervention.

Eligibility criteria: Inclusion Criteria:

* Obesity
* Abnormal Triglyceride levels (\>1.7mmol/L).
* Abnormal HDL-C levels (1.0mmol/L)

Exclusion Criteria:

* Abnormal thyroid unfction (not treated)
* Diabetes

Primary outcomes:
measure: carotid intima media thickness
timeFrame: 12 months
Secondary outcomes:
measure: weight
timeFrame: 12 months
Other outcomes:
measure: Lipid profile
timeFrame: 6 months
measure: lipid profile
timeFrame: 12 months
measure: BMI
timeFrame: 12 months
measure: liver functions
timeFrame: 3 months
measure: liver functions
timeFrame: 6 months
measure: liver functions
timeFrame: 9 months
measure: liver functions
timeFrame: 12 months
measure: creatinine kinase
timeFrame: 3 months
measure: creatinine kinase
timeFrame: 6 months
measure: creatinine kinase
timeFrame: 9 months
measure: creatinine kinase
timeFrame: 12 months
Locations:
city: Montréal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
Study officials:
affiliation: Hopital Maisonneuve-Rosemont, UMontreal
name: Laurent Legault, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06512181: Uterine Preservation in the Management of Placenta Accreta Spectrum Disorders
Official title: Uterine Preservation in the Management of Placenta Accreta Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Placenta Accreta Spectrum
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 15
Sex: FEMALE
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 study for the conservative management of placenta accreta spectrum disorders (PAS), which are a major cause of maternal morbidity and mortality. The most common management strategy for PAS in the United States is a preterm cesarean-hysterectomy. However, accumulating data show that conservative management is safer and is preferred by some patients. In selected participants (n=15) who desire uterine preservation, the investigators provide the option of conservative management, which will be defined as leaving the placenta in the uterus after delivery of the infant. This is a single-arm single-site pilot study where all participants will be carefully monitored during a standard postpartum inpatient stay and with outpatient follow-up until the uterus is empty.


Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. A person with a uterus, age 18 or older
4. Currently 16-36 weeks pregnant with an intrauterine gestation
5. History of cesarean delivery AND placenta previa OR anterior low-lying placenta AND suspected of having PAS on prenatal imaging (ultrasound/MRI)
6. Patients for whom the usual management would be cesarean-hysterectomy.
7. Patient desires uterine preservation
8. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration.

Exclusion Criteria:

• Have a low antenatal suspicion for PAS based on imaging.

Primary outcomes:
measure: Hysterectomy rate
timeFrame: Delivery through 1 year
Secondary outcomes:
measure: Endometritis rate
timeFrame: Delivery through 1 year
measure: Coagulopathy rate
timeFrame: Delivery through 1 year
measure: Frequency of vaginal bleeding
timeFrame: Delivery through 1 year
measure: Frequency of pelvic pain
timeFrame: Delivery through 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Beth Pineles, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06152081: Caries Detection With Two Different Caries Detecting Devices
Official title: A Pilot Clinical Trial Comparing the Efficacy of Caries Detection With a Novel Caries Detecting Rinse and Existing Diagnostic Tools
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caries,Dental
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary aim of this study will be to compare the effectiveness of the novel LumiCare™ rinse and with QLF in determining caries progression. The secondary aim is to compare the progression of carious lesions between patients who reported use of e-cigarettes/vapes and those who did not.


Eligibility criteria: Inclusion Criteria:

* Patients of TUSDM Comprehensive Care Clinic
* Adult patients over the age of 21
* Extreme/High Caries Risk classification per TUSDM Caries Management by Risk Assessment (CAMBRA) form
* Presence of 2 or more initial active primary carious lesions on a free coronal surface of any tooth by visual assessment, QLF, and LumiCare™
* Presence of at least 1 cavitated lesion
* Updated (no more than 6 months old) bite wing radiographs available.
* Patients who responded either yes/no to use of e-cigarettes/vapes
* 1 active caries, 1 inactive caries and 1 sound tooth surface.

Exclusion Criteria:

* Low or moderate caries risk classification per TUSDM CAMBRA form
* No clinically detectable carious lesions on free coronal surfaces
* No cavitated caries lesions
* Carious teeth with caries lesions concomitant with extrinsic stains, fluorosis, or developmental defects.
* Patients who responded yes to the use of conventional cigarettes or smokeless tobacco

Primary outcomes:
measure: Comparison of two caries-detecting devices
timeFrame: 12 months
Secondary outcomes:
measure: Caries progression in those who do and do not use e-cigarettes/vapes
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: Tufts University School of Dental Medicine
name: Karina Irusa, BDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06391281: Effect of Fistula Training in Hemodialysis Patients
Official title: The Effect of Fistula Education Given to Patients Receiving Hemodialysis Treatment on Self-Care Behaviors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemodialysis
Keywords: hemodialysis
Fistula
self care
education
Lead sponsor: Kırklareli University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It was planned to examine the effect of fistula-related education given to patients receiving hemodialysis treatment on their self-care behaviors.

Nurse-led education about fistula for hemodialysis patients affects fistula self-care behaviors.

Nurse-led training regarding fistula to hemodialysis patients does not affect fistula self-care behaviors.

Detailed description: Hemodialysis patients in the experimental group will be given face-to-face training in 2 sessions. Patients will also receive an educational brochure on fistula self-care. Simultaneously, patients will receive routine treatment and care.

No intervention will be performed on patients in the control group. These patients will receive normal treatment and care.

A pre-test will be applied to both groups at the first meeting and their self-care behaviors related to fistula will be examined. Three months later, fistula-related self-care behaviors will be evaluated again with the relevant scale.

Eligibility criteria: Inclusion Criteria:

* 18 years and over,with chronic kidney disease
* Having a fistula as a vascular access route
* Receiving hemodialysis treatment for at least 6 months

Exclusion Criteria:

* Those with acute renal failure,
* Having a graft and catheter as a vascular access route,
* Not volunteering to participate in the research
* Those with communication problems (hearing, language, understanding, etc.)

Primary outcomes:
measure: Patient Information Form
timeFrame: 1-3 month
measure: Self-Care Behavior Assessment Scale Regarding Arteriovenous Fistula in Hemodialysis Patients
timeFrame: 1-3 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03754881: Efficacy of 8-week Supervision in Home Based Pulmonary Rehabilitation
Official title: Efficacy of 8-week Supervision in Home Based Pulmonary Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 41
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic obsturctive pulmonary disease in Asan Medical Center

Brief summary: In korea, it is not easy to practice standard pulmonary rehabilitation (PR). in this study, we'll educate PR to patients and make reservation for re-visiting outpatients clinics with PR diary. we want to confirm whether patients, who perform home based PR during more than 30 minutes in 3 days per week, present improved dyspnea score or quality of life compared with non-compliance group.


Eligibility criteria: Inclusion Criteria:

* forced expiratory volume-one second / forced vital capacity \< 0.7 in post-bronchodilator pulmonary function test
* adults 40 years or older
* no history of acute exacerbation within 4 weeks
* no history of education for pulmonary rehabilitation within 6 months
* no change of medication for chronic obstructive pulmonary disease within 4 weeks
* dyspnea more than Modified Medical Research Council grade 0

Exclusion Criteria:

* adults under 40 years old
* no consent
* history of acute exacerbation within 4 weeks
* history of education for pulmonary rehabilitation within 6 months
* change of medication for chronic obstructive pulmonary disease within 4 weeks
* dyspnea only Modified Medical Research Council grade 0
* comorbidity, including cardiovascular disease, orthopedic disease, neurologic disease, optic disease, uncontrolled hypertension
* enrolled other clinical trial
* on long term oxygen therapy

Primary outcomes:
measure: Change from basline Chronic obstructive pulmonary disease (COPD) assessment Test (CAT) at 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: change from 6 minutes walk test at 8 weeks
timeFrame: 8 weeks
measure: Change from the Short Form 36 Health survey (SF-36), version 2.0 at 8 weeks
timeFrame: 8 weeks
measure: Change from BODE index at 8 weeks
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Pulmonary and Critical Care Medicine and Clinical Research Center for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan College of Medicine
Study officials:
References:
citation: Lee JH, Lee HY, Jang Y, Lee JS, Oh YM, Lee SD, Lee SW. Efficacy of Unsupervised Home-Based Pulmonary Rehabilitation for Patients with Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2020 Sep 28;15:2297-2305. doi: 10.2147/COPD.S268683. eCollection 2020.
Clinical trial NCT02103881: Ketamine Versus Haloperidol for Severe Agitation Outside the Hospital
Official title: A Double Blinded Randomized Trial of Ketamine Versus Haloperidol for Severe Prehospital Agitation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Agitation
Keywords: Agitation
Ketamine
Haloperidol
Emergency Medical Services
Feeling of restlessness
Increased motor activity
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 0
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: This research study is being done to find out if one of two drugs, ketamine or haloperidol, is better for treating agitation. Agitation is a state of extreme emotional disturbance where patients can become physically aggressive or violent, endangering themselves and those who are caring for them. Often chemical substances or severe mental illness is involved in this level of agitation. Specifically, the investigators are interested in studying agitation that is treated in the prehospital setting by paramedics. This study's hypothesis is that ketamine is superior to haloperidol for treatment of agitation in the prehospital environment.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of severe agitation in the prehospital environment

Exclusion Criteria:

* Prisoners
* Persons known to be younger than 18 years old
* Persons suspected to be younger than 18 years old
* Obviously gravid women
* Persons with profound agitation
* Persons who are unable to be transported to the treating facility

Primary outcomes:
measure: Time from injection of drug to adequate sedation, defined as a score of 0 or less on the AMSS.
timeFrame: 2 hours
Secondary outcomes:
measure: Number of participants intubated.
timeFrame: 2 hours
measure: venous pH
timeFrame: at one minutes and ten minutes post sedation
measure: serum potassium
timeFrame: at one minute and ten minutes post sedation
measure: Total time the participant is a patient in the Emergency Department.
timeFrame: 2 hours
measure: Number of patients admitted versus number of patients discharged.
timeFrame: 2 hours
measure: venous lactate
timeFrame: at one minute and ten minutes post sedation
measure: Number of patients experiencing laryngospasm.
timeFrame: 2 hours
measure: Number of patients experiencing dystonia.
timeFrame: 2 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04129281: Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma
Official title: Prospective Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Papillary Microcarcinoma of the Thyroid
Keywords: Papillary Microcarcinoma of the Thyroid
Surgery
Outcome
Follow up
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to surgery or active surveillance. Patients who refuse the randomization process will be followed according to the treatment choice according to clinical practice.
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the outcome of two treatment approaches (immediate surgery or close follow-up) in patients with papillary thyroid microcarcinoma (mPTc) .

Detailed description: The primary objective of this study is to evaluate the outcome of two treatment approaches (immediate surgery or close follow-up) in patients with papillary thyroid microcarcinoma (mPTc) .

A further objective is to identify events associated with high risk of local recurrence and distant metastases.

Patients will be randomized to surgery or active surveillance. Patients who refuse the randomization process will be followed according to the treatment choice according to clinical practice.

Eligibility criteria: Inclusion Criteria:

* Age \>or =18
* Suspicious nodule \< or = or 13 mm in the maximum size of thyroid ultrasound (not older than 3 months after the screening visit)
* Cytology consistent with the TIR4 or TIR 5 class
* Sieric TSH in th standard range (with or without levo-tyroxin therapy)
* Normal string motility to fibrolaringoscopy
* Written informed consent

Exclusion Criteria:

* Ultrasound evidence of suspicious lump located on the posterior side of the lobe close to neurogene structures
* Calcitonin increase above normal levels
* Clinical or instrumental evidence of locoregional lymph node metastases (central or laterocervical compartment) or remote
* any Contraindications to surgery

Primary outcomes:
measure: Quality of life in patient who received either surgery or follow up
timeFrame: 36 months
Secondary outcomes:
measure: Quality of life in patient who received either surgery or follow up
timeFrame: 36 months
measure: Compare the two strategies in terms of anxiety/depression
timeFrame: 36 months
measure: Compare the two strategies in terms of adverse events
timeFrame: 36 months
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Istitute Nazionale Tumori - Fondazione G. Pascale
Study officials:
affiliation: IRCCS Study Principal Investigator
name: Luciano Pezzullo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06980181: Comparison of Graded Motor Imagery and Mirror Therapy in Chronic Stroke Rehabilitation
Official title: Comparison of Graded Motor Imagery and Mirror Therapy in Chronic Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Speech Disorder
Stroke Rehabilitation
Hypertension
Lead sponsor: Elite College of Management Sciences, Gujranwala, Pakistan
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 44
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Model Description
Primary purpose: TREATMENT

Brief summary: The study is conducted to assess whether the GMI or MT reduce the level of spasticity. Also to compare the level of independence in GMI and MT in the chronic stroke patients.

Detailed description: A stroke is a medical condition that occurs when inadequate blood flow to a part of the brain leads to cell death. There are two primary types of strokes: ischemic, caused by reduced blood flow, and hemorrhagic, caused by bleeding. Both types result in impaired brain function in the affected areas.

A systemic review was conducted on the effectiveness of mirror therapy on lower extremities, stal and walk in early stage and long term stroke. Results shown better results with using mirror the than control group.

Non-randomized controlled trial study was conducted on stroke patients treated by graded n imagery. It consisted of 28 subjects and the experimental group included 14 and other 14 included in the control group. Graded motor imagery showed better results than the convent therapy as 10 patients showed better outcomes in the intervention group and only 4 patients sho improvement in the control group.

Eligibility criteria: Inclusion Criteria:

* Age:45 to 65 years
* First ever unilateral stroke and over 3 months since onset.
* Both ischemic and hemorrhagic stroke individuals were included.

Exclusion Criteria

* Patients suffering from psychological problems.
* Visual Impairments.
* Fractures.
* Any other Neurological disorder
* Inflammatory joint diseases
* Medical instability e.g Uncontrolled HTN
* Any systemic disease

Primary outcomes:
measure: Modified Ashworth Scale
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Paraplegic Center
state: Khyber Pakhtunkhwa
Study officials:
affiliation: Elite College of Management Sciences
name: Mahnoor Hassan, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gandhi DB, Sterba A, Khatter H, Pandian JD. Mirror Therapy in Stroke Rehabilitation: Current Perspectives. Ther Clin Risk Manag. 2020 Feb 7;16:75-85. doi: 10.2147/TCRM.S206883. eCollection 2020.
citation: Gallanagh S, Quinn TJ, Alexander J, Walters MR. Physical activity in the prevention and treatment of stroke. ISRN Neurol. 2011;2011:953818. doi: 10.5402/2011/953818. Epub 2011 Oct 1.