louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03765008: The Effect of Water Intake on Glucose Regulation
Official title: The Effect of Water Intake on Glucose Regulation: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Glucose Metabolism Disorders
Dehydration (Physiology)
Water Deprivation
Keywords: water
vasopressin
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: There is a growing body of evidence suggesting low water intake and elevated levels of the hormone vasopressin exacerbate glucose regulation. This project will examine the physiological mechanism by which low water intake impairs glucose homeostasis.

In the current proposal we aim to: 1) quantify the degree of glucose impairment as a response to elevated vasopressin due to low water intake and 2) identify the physiological mechanism by which elevated vasopressin, as a response to low water intake, impairs glucose regulation


Eligibility criteria: Inclusion Criteria:

BMI 27.5-35

Exclusion Criteria:

* BMI \<27.5 or \>35
* high physical activity
* diabetes
* impaired liver or kidney function
* cardiovascular disease
* weight change of more than 3 kg in the past month
* pregnancy
* previous surgery on digestive tract (except appendectomy)
* fluid balance will be exclusionary such as
* serotonin re-uptake inhibitors.

Primary outcomes:
measure: amount of glucose metabolized M
timeFrame: 220-240 min & 340-360 min of the protocol
measure: metabolic clearance rate for insulin
timeFrame: 220-240 min & 340-360 min of the protocol
measure: quantity of glucose metabolized per unit plasma insulin concentration
timeFrame: 220-240 min & 340-360 min of the protocol
measure: Rate of glucose appearance & disappearance
timeFrame: 220-240 min & 340-360 min of the protocol
Secondary outcomes:
measure: Plasma copeptin
timeFrame: 0 min, 240 min & 360 min of the protocol
measure: glucagon
timeFrame: 0 min, 240 min & 360 min of the protocol
measure: Cortisol
timeFrame: 0 min, 240 min & 360 min of the protocol
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05566808: Use of Allograft Cartilage in Cosmetic and Reconstructive Rhinoplasty
Official title: Prospective Trial Evaluation the Long-term Outcomes Associated With the Use of MTF Allograft Cartilage in Cosmetic and Reconstructive Rhinoplasty Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhinoplasty
Lead sponsor: Musculoskeletal Transplant Foundation
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-center, blinded, controlled trial, conducted in healthy adult subjects undergoing a reconstructive or cosmetic rhinoplasty involving the use of cartilaginous graft (either non-irradiated cartilage sheet allograft compared to autologous harvest and grafting of costal cartilage).


Eligibility criteria: Inclusion Criteria:

* Subject is scheduled to undergo a reconstructive or cosmetic surgical procedure to alter the appearance of the nose that is anticipated to require a cartilage graft.
* Subject is willing to sign an informed consent.
* Subject is a non-smoker or has stopped smoking at least 6-weeks prior to inclusion in the study.
* Subjects must agree to forgo any treatment, medical or non-medical, to the area treated in this study, for the duration of the 1-year post-treatment evaluation period, unless there is prior approval from the investigator.

Exclusion Criteria:

* Presence of significant endocrine, immunologic, dermatologic or psychiatric abnormalities that would render the subject an inappropriate candidate for the study.
* Presence of any malignancy not considered cured in the midface area specifically (no evidence of cancer recurrence in the previous five years).
* History of radiation to the area(s) to be treated in the study.
* Subjects taking chronic steroids (injected or oral) or other immune modulators.
* Subjects with a history of skin sensitivity (dermatitis) to either the suture materials or dressings to be utilized during the course of this study.
* Subjects with skin conditions that could result in poor healing or widened scars.

Primary outcomes:
measure: Patient Outcome Assessment
timeFrame: Preoperative
measure: Patient Outcome Assessment
timeFrame: 3 months post-operative
measure: Patient Outcome Assessment
timeFrame: 6 months post-operative
measure: Patient Outcome Assessment
timeFrame: 12 months
Secondary outcomes:
measure: Cost analysis of utilizing the different grafts as far as graft cost, operative time, re-operation, etc.
timeFrame: 12 months
measure: Comparison of the overall complication rate between the MTF cartilage graft and autologous cartilage graft used during the procedures.
timeFrame: 12 months
Other outcomes:
measure: Safety: occurrence of adverse events (AEs)
timeFrame: 12 months
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
References:
Clinical trial NCT02983708: Neuroregenerative Potential of Intravenous G-CSF and Autologous Peripheral Blood Stem Cells
Official title: Neuroregenerative Potential of Intravenous G-CSF and Autologous Peripheral Blood Stem Cells in Children With Cerebral Palsy: a Randomized, Double-blind Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Neurodegeneration
G-CSF
Peripheral Blood Mononuclear Cells
Cerebral Palsy
Keywords: Neuroregeneration
G-CSF
Peripheral blood mononuclear cells
Cerebral palsy
Lead sponsor: Hanyang University Seoul Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
First posted: 2016-12-06
Enrollment: 57
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The current study describes a randomized, double-blind, cross-over study of intravenous G-CSF followed by infusion with autologous mobilized peripheral blood mononuclear cells (mPBMCs) in children with cerebral palsy (CP) to determine the safety and feasibility of the procedure, as well as the potential efficacy for improving neurological impairment.

Detailed description: We hypothesized that mobilized peripheral blood mononuclear cells (mPBMCs) would be a better source of cell therapy for children with CP, if these cells had a similar neuroregenerative potential to bone marrow/cord blood mononuclear cells (MNCs). Multipotent precursor cells exist in peripheral blood, and a fraction of elutriated blood cells from normal individuals contains MNCs that have the potential to be MSCs. There are several advantages to using mPBMCs for cell therapy in children with CP: the G-CSF that is used to mPBMCs has neuroregenerative potential; the collection and fractionation of stem cells can be repeated; and, the therapy is suitable for most children with CP.

Eligibility criteria: Inclusion Criteria:

* Non severe type of cerebral palsy
* Evidences of abnormal MRI findings such as periventricular leukomalacia
* Collected mobilized peripheral blood mononuclear cell counts \> 1×10\^8/kg or CD34+ cell counts \> 1×10\^6/kg
* Consent form

Exclusion Criteria:

* Previous trials of autologous cord blood infusion or erythropoietin/G-CSF
* Chromosomal abnormalities

Primary outcomes:
measure: Overall improvement as a score changes in GMFM > 4 points
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Rah WJ, Lee YH, Moon JH, Jun HJ, Kang HR, Koh H, Eom HJ, Lee JY, Lee YJ, Kim JY, Choi YY, Park K, Kim MJ, Kim SH. Neuroregenerative potential of intravenous G-CSF and autologous peripheral blood stem cells in children with cerebral palsy: a randomized, double-blind, cross-over study. J Transl Med. 2017 Jan 21;15(1):16. doi: 10.1186/s12967-017-1120-0.
Clinical trial NCT04545008: Trial of Famotidine & N-Acetyl Cysteine for Outpatients With COVID-19
Official title: A Phase I Clinical Trial of the Combination of Famotidine (FAM) and Oral N-Acetyl Cysteine (NAC) Open Label for Outpatient Treatment of Subjects With Newly Diagnosed SARS-CoV-2 Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Covid19
Keywords: outpatient
famotidine
n-acetyl cysteine
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: Clemson University
First posted: 2020-09-10
Enrollment: 2
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 purpose of this trial is to assess the safety and toxicity profile of the combination of famotidine and oral n-acetyl cysteine in adult outpatients with newly diagnosed SARS-CoV-2 infection.

Detailed description: This is a phase I trial enrolling subjects with newly diagnosed SARS-CoV-2 infection who do not require hospitalization. Exclusion criteria have been written to exclude patients who would be expected to have increased risk from either medication alone. Subjects will be assigned a dose combination of famotidine and n-acetyl cysteine. In addition to assessing the safety and toxicities profiles of the combination of drugs we will be measuring certain endpoints to assess possible efficacy. These endpoint include the following: rates of hospitalization; time to complete remission of symptoms, e.g, fever, respiratory symptoms, etc.; severity of symptoms with validated survey instruments; cytokine values in serum and urine; and markers of inflammation and oxidative stress.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* performance of a SARS-CoV-2 test within 1 day of enrollment, N.B., must be positive to proceed to treatment phase of the trial

Exclusion Criteria:

* All patients under 18
* Known allergy to N-Acetyl Cysteine
* Known allergy to famotidine or other H2-receptor antagonists
* Pregnant or Nursing Mothers
* Laboratory Evidence or History of Renal Impairment (eGFR \< 30 mL/min/1.73 m2)
* Taking H2-receptor antagonists, hydroxychloroquine or chloroquine.
* Patient has been admitted to the hospital prior to study enrollment

Primary outcomes:
measure: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
timeFrame: 0 to 30 days
Secondary outcomes:
measure: Rate of Hospitalization
timeFrame: 0 to 30 days
measure: Time to Symptom Resolution
timeFrame: 0 to 30 days
Other outcomes:
Locations:
city: Easley
country: United States
facility: Prisma Health Baptist Easley Hospital
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Greenville Memorial Hospital
state: South Carolina
city: Greer
country: United States
facility: Prisma Health Greer Memorial Hospital
state: South Carolina
Study officials:
affiliation: Prisma Health
name: John J O'Connell, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03103308: Hematopoetic Stem Cell Transplant and Physical Function
Official title: Effects of a Multidirectional Walking Program on Physical Function and Quality of Life in Hematopoetic Stem Cell Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Walking
Keywords: Cancer
Exercise
Physical Function
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study will determine if a structured walking intervention will help maintain or improve physical activity levels, physical function and quality of life in hematopoietic stem cell transplant patients.

Detailed description: The researchers will quantify the decline in physical function of HSCT patients using valid and reliable tests aimed to mimic activities of daily living, quantify cardiovascular health, and quantify muscle power declines. Also, patients will undergo a walking program during their hospitalization, which is designed to increase physical activity levels and maintain and improve physical function and quality of life. Additionally, using valid and reliable questionnaires, the researchers will gauge perception of exercise, quantify current exercise levels, determine preference of exercise programs and counseling, and measure differences in quality of life before and after HSCT treatment.

Eligibility criteria: Inclusion Criteria:

* Be between 40 and 80 years of age
* Willing and able to provide written informed consent in English
* Ability to comprehend the purpose of the study
* Be scheduled to receive an autologous or allogeneic hematopoietic stem cell transplant at Sylvester Comprehensive Cancer Center
* Have an expected hospital stay of at least 2 weeks
* Not currently be participating in an exercise training program

Exclusion Criteria:

* Dementia, altered mental status, or psychiatric condition
* Received erythropoiesis-stimulating proteins within 4 weeks prior to enrollment
* Comorbid conditions that would contraindicate exercise testing
* Undergoing concurrent non-transplant-related chemotherapy or radiation

Primary outcomes:
measure: The Physical Performance Test Battery
timeFrame: 10 minutes
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy: Bone Marrow Transplant Questionaire Related Quality of Life
timeFrame: 20 minutes
measure: Patient Reported Outcome Measurement Information System
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
Study officials:
References:
Clinical trial NCT06303908: How Traditional Chinese Medicine Exercise Improves Parkinson Disease
Official title: How Traditional Chinese Medicine Exercise Improves Parkinson Disease: A Preliminary Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Ahmadu Bello University Teaching Hospital
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to explore the impact of Simple Gymnastics Training on Limb motor function and mental health in Parkinson's Patients in the Community (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of Parkinson's Diseases among community-dwelling elderly individuals, and 2) the effects of Simple Gymnastics Training on Limb motor function and mental health in community-dwelling Parkinson's Patients. All patients are required to undergo a continuous three-week (21 days) Simple Gymnastics Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

Detailed description: In the early stages of Parkinson's disease, many patients do not seek medical attention. The goal of this clinical trial is to explore the impact of Simple Gymnastics Training on Limb motor function and mental health in Parkinson's Patients in the Community (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of Parkinson's Diseases among community-dwelling elderly individuals, and 2) the effects of Simple Gymnastics Training on Limb motor function and mental health in community-dwelling Parkinson's Patients. All patients are required to undergo a continuous three-week (21 days) Simple Gymnastics Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

Eligibility criteria: Inclusion Criteria:

* Age \>60 years.
* Meeting the diagnostic criteria for Parkinson's disease developed by the Neurology Branch of the Chinese Medical Association in 2006.

Exclusion Criteria:

* Complicated with cognitive impairment or consciousness dysfunction.
* Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale
timeFrame: day 1 and day 21
Secondary outcomes:
measure: The Berg Balance Scale
timeFrame: day 1 and day 21
measure: Patient Health Questionnaire-9
timeFrame: day 1 and day 21
measure: Generalized Anxiety Disorder-7
timeFrame: day 1 and day 21
Other outcomes:
Locations:
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis, Master
role: STUDY_CHAIR
References:
Clinical trial NCT03775408: FAST: Clinical Feasibility
Official title: Femoral Antegrade Starting Tool (FAST): Clinical Feasibility Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Femur Fracture
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2018-12-13
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized at Sunnybrook Health Sciences Centre

Brief summary: This study evaluates the clinical ease of use of the Femoral Antegrade Starting Tool (FAST).

Detailed description: The investigators will recruit 10 patients at Sunnybrook Health Sciences Centre that are scheduled to receive femoral antegrade intramedullary nailing to treat a femur fracture. This study evaluates the clinical ease of use of the Femoral Antegrade Starting Tool (FAST) device, and the surgical workflow during entry point selection and guidewire alignment for intramedullary nailing of femoral fractures. It is hypothesized that the usage of the tool will reduce surgery time and number of images required.

Eligibility criteria: Inclusion Criteria:

* Patients with a femoral shaft fracture
* Undergoing anterograde intramedullary nailing procedure

Exclusion Criteria:

* Femoral head or neck fractures

Primary outcomes:
measure: Procedure Time
timeFrame: 1 day
Secondary outcomes:
measure: Fluoroscopic Images
timeFrame: 1 day
measure: Number of guidewire drilling attempts
timeFrame: 1 day
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Sebastian Tomescu, MD MSc FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ebrahimi H, Yee A, Whyne C. Surgical process analysis identifies lack of connectivity between sequential fluoroscopic 2D alignment as a critical impediment in femoral intramedullary nailing. Int J Comput Assist Radiol Surg. 2016 Feb;11(2):297-305. doi: 10.1007/s11548-015-1262-6. Epub 2015 Jul 21.
Clinical trial NCT03663608: Wide Awake Local Anesthesia No Tourniquet
Official title: Wide Awake Local Anesthesia No Tourniquet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trigger Finger Disorder
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Isolated Trigger finger, diagnosis confirmed by sonography and indication of surgical release

Brief summary: The main objective is to assess patient's satisfaction regarding pure local anaesthesia and without use of a tourniquet (WALANT Technique) for trigger finger release surgery.


Eligibility criteria: Inclusion Criteria:

* Patients of age
* Isolated Trigger finger, diagnosis confirmed by sonography and with indication of surgical release
* Patients protected by health insurance
* Patients who have received proper information on the current research proctol, and did not refuse to enter the study

Exclusion Criteria:

* Hand vascular disorders ( History of finger replantation surgery, clinical signs of poor hand vascularization
* Hypersensitivy to Xylocain or Adrenalin or one of it's components
* Other surgical act planned to be performed during the same anaesthesia
* Pregnant or Breastfeeding women
* Patients of age and under the protection of a conservator, patients deprived of liberty

Primary outcomes:
measure: Patient satisfaction
timeFrame: one day after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Plérin
country: France
facility: Centre Hospitalier Privé de Plérin
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References:
Clinical trial NCT04858308: Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506.
Official title: Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dyslipidemias
Lead sponsor: Yooyoung Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-26
Enrollment: 554
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicenter, Double-blind, Randomized, Active-controlled, Double dummy, Parelle-group comparative.
Primary purpose: TREATMENT

Brief summary: Phase 3 study to evaluate the effiacay and safety of YYC506

Detailed description: Phase 3 study to evaluate the effiacay and safety of YYC506 in patients with complex dyslipidemia where LDL-C is properly controlled but TG and HDL-C levels are not regulated by Atorvastatin alone.

Eligibility criteria: Inclusion Criteria:

* A man or woman over 19 years old.
* LDL-C properly controlled, TG, HDL-C is not properly controlled
* Sign on ICF prior to study participation

Exclusion Criteria:

* History of Fibromyalgia, Myopathy etc (CK ≥ 2XULN)
* Uncontrolled hypo-thyroidism (TSH≥1.5XULN)
* Severe renal impairemnet (Creainine clearance \< 30mL/min) etc.

Primary outcomes:
measure: Percent change (%) of non-HDL-C from baseline
timeFrame: from baseline at 12 weeks
Secondary outcomes:
measure: Percent change (%) of non-HDL-C
timeFrame: from baseline at 4, 8, 14 weeks.
measure: Percent change (%) of lipid parameters
timeFrame: from baseline at 4, 8, 12, 24 weeks
measure: Percent change (%) of diabetes parameters
timeFrame: from baseline at 4, 8, 12, 24 weeks
Other outcomes:
Locations:
city: Cheonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National UniversityHospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyo-soo Kim, Ph.D
role: STUDY_CHAIR
affiliation: Seoul National University Hospital
name: Hyo-soo Kim, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: Soo Lim, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: