louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03873506: Follow-Up Study of Mesenchymal Stem Cells for Bronchopulmonary Dysplasia
Official title: Follow-Up Study of Safety and Efficacy of Mesenchymal Stem Cells in Preterm Infants With Moderate or Severe Bronchopulmonary Dysplasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Bronchopulmonary Dysplasia
Keywords: Bronchopulmonary Dysplasia
human umbilical cord -derived mesenchymal stem cells
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a follow-up study to investigate the long-term safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs), for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the PhaseⅠtrial (NCT03558334 ) will be followed-up until 48 months after the hUC-MSCs transplantation.

Detailed description: Subjects who completed the initial stage of the PhaseⅠclinical trial will be followed-up at 5 additional visits: 1, 3, 6, 12 and 24 months after the hUC-MSCs transplantation.

Eligibility criteria: Inclusion Criteria:

1. Subject who completed the safety and efficacy evaluations in hUC-MSCs PhaseⅠ clinical trial
2. Subject with a written consent form signed by a legal representative or a parent

Exclusion Criteria:

1. Subject whose parent or legal representative does not agree to participate in the study
2. subject who is considered inappropriate to participate the study by the investigator

Primary outcomes:
measure: Readmission rate
timeFrame: within two years
measure: Duration of the hospital stay due to respiratory infection
timeFrame: within two years
Secondary outcomes:
measure: Rate of Survival
timeFrame: within two years
measure: Incidence of Tumorigenicity
timeFrame: within two years
measure: Growth measured by Z-score
timeFrame: within two years
measure: Number of neurological developmental delay
timeFrame: within two years
measure: Number of blindness and deafness
timeFrame: within two years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Children's Hospital of Chongqing Medical University
name: Zhou Fu
role: STUDY_CHAIR
References:
citation: Chang YS, Ahn SY, Yoo HS, Sung SI, Choi SJ, Oh WI, Park WS. Mesenchymal stem cells for bronchopulmonary dysplasia: phase 1 dose-escalation clinical trial. J Pediatr. 2014 May;164(5):966-972.e6. doi: 10.1016/j.jpeds.2013.12.011. Epub 2014 Feb 6.
citation: Ahn SY, Chang YS, Kim JH, Sung SI, Park WS. Two-Year Follow-Up Outcomes of Premature Infants Enrolled in the Phase I Trial of Mesenchymal Stem Cells Transplantation for Bronchopulmonary Dysplasia. J Pediatr. 2017 Jun;185:49-54.e2. doi: 10.1016/j.jpeds.2017.02.061. Epub 2017 Mar 21.
Clinical trial NCT04706806: Effect of Daily Vinegar Ingestion for Four Weeks on Mood State in Healthy College Students
Official title: Effect of Daily Vinegar Ingestion for Four Weeks on Mood State in Healthy College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood
Depression
Keywords: acetic acid
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this research is to record mood states and depression levels in healthy college students before and after 4 weeks of daily vinegar ingestion.

Detailed description: Recent research suggests that fruit and vegetable intake is inversely associated with mood states and depression. Although the mechanism is not known, increased gut fermentation is suspected as changes in gut tryptophan metabolism was noted in these trials. Tryptophan is the precursor to serotonin, the neurotransmitter associated with improved mood state, but other metabolites of tryptophan have been associated with mental wellbeing as well. The main ingredient of vinegar, acetic acid, is the most common metabolite produced during gut fermentation of dietary fiber (mainly from fruits and vegetables) and can also be expected to influence the gut microbiome. It has been reported that vinegar ingestion is linked to a change in tryptophan metabolism in healthy adults consuming vinegar daily for 8 weeks. This study will explore the impact of vinegar ingestion on mood states.

Eligibility criteria: Inclusion Criteria:

* college student, non-athlete, no chronic health condition

Exclusion Criteria:

* vegetarians or others adhering to special diet, body mass index \>30 kg/m2, pregnancy/lactation, unwilling to ingest vinegar

Primary outcomes:
measure: mood state
timeFrame: change from baseline at day 28
measure: depression
timeFrame: change from baseline at day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References:
Clinical trial NCT00596999: A Single-arm Safety Study of Transplantation Using Umbilical Cord Blood and Human Placental-derived Stem Cells From Partially Matched Related Donors in Persons With Certain Malignant Blood Diseases and Non-malignant Disorders
Official title: A Single-Arm Study to Assess the Safety of Transplantation With Umbilical Cord Blood Augmented With Human Placental-Derived Stem Cells From Partially Matched Related Donors in Subjects With Certain Malignant Hematologic Diseases and Non-Malignant Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hematologic Malignancies
Keywords: Myelodysplastic Syndrome (MDS)
Acute myelogenous Leukemia (AML)
Acute Lymphocytic Leukemia (ALL)
Sickle Cell Disease (SCD)
Beta Thalassemia
Inborn Errors of Metabolism
Severe Combined Immunodeficiency Disease (SCID)
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2008-01-17
Enrollment: 6
Sex: ALL
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects requiring cord blood transplantation

Brief summary: To investigate the safety of partially matched related human placental-derived stem cells (HPDSC) administered in conjunction with umbilical cord blood (UCB) stem cells from the same donor in subjects with various malignant or nonmalignant disorders potentially curable with stem cell transplantation and to assess potential restoration of normal hematopoiesis and immune function in subjects with these disorders


Eligibility criteria: Inclusion Criteria:

* suitable UCB collected from partially or fully HLA matched related donor
* subject requires umbilical cord transplantation

Exclusion Criteria:

* any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
* major anticipated illness or organ failure incompatible with survival from stem cell transplant

Primary outcomes:
measure: Incidence of GVHD, time to engraftment and survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Louisiana State University Children's Hospital
state: Louisiana
Study officials:
affiliation: Louisiana State University Children's Hospital
name: Lolie Yu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00197899: Low-Dose Endotoxemia and the Acute Phase Response
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endotoxemia
Sepsis
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2005-09-20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpuse of this study is to examine the acute phase respons when different doses of E. Coli Endotoxin is injected in healty volunters.


Eligibility criteria: Inclusion Criteria: Healty volunteers -

Exclusion Criteria:

Infection 14 days prior to the trial Regular medication Present and /or former heart disease -

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Intensive Care
state: Copenhagen County
Study officials:
affiliation: Department of Infectious Diseases 7641, University Hospital of Copenhagen, H:S Rigshospitalet
name: Bente K Pedersen, MD, DMSc
role: STUDY_CHAIR
affiliation: Department of Intensive Care, Herlev University Hospital
name: Dorthe H Olsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Intensive Care, Herlev University Hospital
name: Dorthe H Olsen, DM
role: STUDY_DIRECTOR
References:
Clinical trial NCT00126399: A Clinical Trial to Determine the Effects of 40 Mg Doxycycline Versus a Placebo Control for the Treatment of Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rosacea
Keywords: rosacea
acne rosacea
Lead sponsor: CollaGenex Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-08-04
Enrollment: 528
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 objective of this study is to evaluate the safety and efficacy of 40 mg doxycycline controlled-release capsules administered once daily for the treatment of rosacea compared with a placebo.


Eligibility criteria: Main Inclusion Criteria:

* Healthy patients with rosacea
* Males and females ≥18 years of age
* 10 to 40 papules and pustules and ≤2 nodules
* Score of 2 to 4 on the IGA
* Presence of telangiectasia
* Moderate to severe erythema

Main Exclusion Criteria:

* Use of topical acne treatments or topical or systemic antibiotics
* Use of systemic retinoids within 90 days of baseline
* Use of an investigational drug within 90 days of baseline
* Pregnant or nursing women
* Women of childbearing potential not using an adequate form of contraception
* Change in method of contraception within 4 months of baseline
* Known hypersensitivity to tetracyclines
* Surgeries that bypass or exclude the duodenum or achlorhydria

Primary outcomes:
measure: Change in total inflammatory lesion count
Secondary outcomes:
measure: Change from baseline in erythema scale scores
measure: change from baseline in the investigator's global assessment (IGA) score
measure: proportion of patients being clear or near-clear at endpoint
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06196099: Combining Resting Blood Flow Restriction with Neuromuscular Electrical Stimulation: Effects on Blood Lactate Levels and Lower Limb Muscle Function
Official title: Combining Resting Blood Flow Restriction with Neuromuscular Electrical Stimulation: Effects on Blood Lactate Levels and Lower Limb Muscle Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Sahmyook University
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The current research landscape shows studies indicating increased muscle strength and hypertrophy through neuromuscular electrical stimulation combined with blood flow restriction. However, there is a lack of research specifically on the effects of this combination during rest periods. Therefore, the primary objective of this study is to investigate the impact of resting blood flow restriction training combined with neuromuscular electrical stimulation on blood lactate levels and changes in lower limb muscle function in healthy male adults.


Eligibility criteria: Inclusion Criteria:

* Healthy adult males in their 20s,
* Individuals who answered less than one item on the PAR-Q (Physical Activity Readiness Questionnaire),
* Participants who consented to the use and publication of their physical function evaluation data and expressed a desire to participate in the exercise experiment.

Exclusion Criteria:

* Individuals with severe hypertension (blood pressure above 170/110 mmHg),
* Individuals with a history of deep venous thrombosis,
* Individuals with endothelial dysfunction,
* Individuals with peripheral vascular disease,
* Individuals with one or more of the following conditions: diabetes, infection, cancer,
* Participants who expressed a desire to withdraw during the study period or whose participation rate was below 80% were excluded from the study.

Primary outcomes:
measure: Blood lactate
timeFrame: Immediate change from baseline after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Honam University
Study officials:
References:
Clinical trial NCT05700799: HEalth Advocate for Liver Transplant - Pilot
Official title: HEalth Advocate for Liver Transplant - Pilot
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Transplant; Complications
Pediatric ALL
Keywords: Health Advocate
Patient Navigator
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-01-26
Enrollment: 10
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Health Advocate for Liver Transplant (HEAL-Tx) Pilot is a nonrandomized, open-label intervention pilot of a health advocate intervention aimed to assess feasibility and acceptability of integrating a Health Advocate onto the transplant team. Across studies, health advocate roles vary, and can include coordinating medical care treatment, facilitating financial assistance (e.g., taxi vouchers), and connecting patients to community resources, which can improve self-management, mitigate social risks, and lead to better communication between the healthcare system and the family. In this pilot, the investigators will adapt this intervention for pediatric liver transplant patients and measure acceptability and feasibility according to RE-AIM.


Eligibility criteria: Inclusion Criteria:

1. Patients under 18 years if age that have undergone liver transplantation.
2. Subject and/or parent/legal guardian can provide written informed consent and willing to comply with study procedures.
3. Subject and/or parent/ legal guardian is willing to be contacted in the future by study staff.
4. Patient and/or caregiver felt to be a good fit for this pilot by transplant team.

Exclusion Criteria:

* Caregiver unwilling or unable to complete the survey.
* Child is a ward of the state (e.g. foster care) since present circumstances may not be reflective of child's past or future circumstances.
* Non-English, non-Spanish speakers.
* Non-US residents.
* Greater than 18 years of age at the time of enrollment.

Primary outcomes:
measure: Changes in caregiver experience
timeFrame: Baseline and 90 days
Secondary outcomes:
measure: Change in medication adherence using MLVI
timeFrame: Baseline, 90 days, and 180 days
measure: The quality of health advocate interactions with the participants, healthcare team, and community-based resources.
timeFrame: 90 days
measure: A qualitative assessment of caregiver and healthcare provider satisfaction with the Health Advocate intervention.
timeFrame: 90 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sharad Wadhwani, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00970099: Mechanism of Insulin-Resistant in Lean Non-Diabetics
Official title: Mechanism of Exercise Training in Lean Insulin-Resistant Non-Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Insulin Resistance
Insulin Sensitivity
Type 2 Diabetes
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-09-02
Enrollment: 149
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to test the following primary hypothesis:

* Aerobic exercise training will improve insulin sensitivity in insulin resistant subjects through changes in the major cellular signaling pathways and and/or their regulators.

Accordingly, the proposed study is designed to accomplish the following specific aims:

* Quantitate how exercise training improves insulin sensitivity and decreases cardiovascular risk factors in a general population of lean, nondiabetic, insulin resistant subjects. Effects on known cardiovascular risk factors including blood pressure and serum lipoproteins will be evaluated. Change in regional adiposity will also be measured
* Determine the effects of a program of regular aerobic exercise on in the insulin receptor signaling pathway. Biopsies of vastus lateralis muscle from insulin resistant subjects will be obtained before and after a hyperinsulinemic glucose clamp. This procedure will take place in the untrained state and after exercise training. The investigators will measure changes in the insulin receptor and the activity of the major components of the intracellular insulin signaling pathway. The investigators will also look intracellular proteins that regulate this signaling pathway.


Eligibility criteria: Inclusion Criteria:

* Men and women aged 20-50
* No regular exercise for past 2 years

Exclusion Criteria:

* Diabetes, Cardiovascular disease, Pregnant or lactating females,BMI \>27
* Medications that may interfere with carbohydrate metabolism - glucocorticoids, adrenergic agonists, ACE inhibitors, alpha blockers, diuretics, beta blockers, oral contraceptives, HMG CoA reductase inhibitors
* History of epilepsy, cancer, hepatitis, active infection, active Graves' disease, cystic fibrosis, sickle cell anemia, peripheral vascular disease, cerebrovascular disease, asthma
* Any medical condition that in the opinion of the investigator will interfere with safe completion of the trial
* Inability to give informed consent
* Prior participation in a clinical trial that could potentially alter insulin sensitivity: e.g., use of new insulin sensitizers
* HIV seropositive
* Anemia (Hgb \< 12 g/dl)

Primary outcomes:
measure: insulin sensitivity and insulin signaling
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Ucsf Gcrc
state: California
Study officials:
References:
Clinical trial NCT02254499: Prediction of Pain After Total Knee Arthroplasty
Official title: Prospective Descriptive Study of Nociceptive and Psychological Prediction of Pain After Total Knee Arthroplasty (TKA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2014-10-02
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with knee osteoarthritis referred for total knee arthroplasty.

Brief summary: Despite improvements in treatment, a significant part of patients have severe pain following knee arthroplasty. Preoperative identification of high-risk patients would allow for an intensive individualized analgesic treatment pre- and postoperatively and thus potentially in reduced pain acute and chronically.


Eligibility criteria: Inclusion Criteria:

* primary unilateral TKA
* caucasian
* 50 - 80 years
* osteoarthritis

Exclusion Criteria:

* deficient written or spoken danish
* impairment from psychological og neurological disease
* expected discharged to rehabilitation facility
* anticoagulant therapy
* allergies to analgesic treatment
* hypertension (systolic \> 160 / diastolic \> 100)
* ASA class ≥ 4

Primary outcomes:
measure: Pain
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Pain
timeFrame: 48 hours postoperatively
measure: Pain
timeFrame: From day 1 to day 14 following surgery
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte Hospital
Study officials:
References:
Clinical trial NCT03840499: The Role of Willingness of Participation in Cardiology Trials on the Survival of Patients
Official title: The Role of Willingness of Participation in Cardiology Trials on the Survival of Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction
Chronic Heart Failure
Lead sponsor: Semmelweis University Heart and Vascular Center
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible subjects hospitalised due to myocardial infarction and or heart failure.

Brief summary: It has been shown retrospectively that participation and even the willingness improves the survival of patients after myocardial infarction or heart failure. We aimed to prospectively analyse the role of participation in cardiology trials on the survival of patients in a high volumen tertiary center.


Eligibility criteria: Inclusion Criteria:

* Hospitalisation due to acute myocardial infarction, and or heart failure
* Singed informed consent

Exclusion Criteria:

* Previous participation in any clinical study
* Haemodinamically instable, shock, intubation
* Pregnancy, breast feeding

Primary outcomes:
measure: All-cause mortality
timeFrame: 2-years
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University, Heart and Vascular Center
Study officials:
References: