louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03925649: Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Treatment of SCI
Official title: Individual Patient Expanded Access IND (Investigational New Drug) of Autologous HB-adMSCs for the Treatment of Spinal Cord Injury
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Spinal Cord Injury at C5-C7 Level
Keywords: SCI
stem cells
quadriplegia
spinal cord injury
paralysis
MSCs
Lead sponsor: Hope Biosciences
Sponsor class: INDUSTRY
Collaborators: name: The University of Texas Health Science Center, Houston
First posted: 2019-04-24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This study is expanded access to an Investigational New Drug (IND) for an individual patient with spinal cord injury (SCI) at cervical spine 5-6 (C 5-6) designed to provide access to autologous adipose-derived mesenchymal stem cells (HB-adMSCs)

Detailed description: This is an expanded access single-dose study with the primary goal of treatment submitted at the request of an individual patient with complete C5-6 spinal cord injury (SCI) resulting in quadriplegia who does not qualify for any current clinical trials and for whom there are no other FDA approved fully restorative treatments. The overall objective of this study is to evaluate patient's response, adverse events and serious adverse events (AE/SAEs), and cell expansion characteristics of a single intravenous (IV) infusion of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in a subject with complete SCI resulting in quadriplegia.

Eligibility criteria: Inclusion Criteria:

* Cognitively intact, capable of giving informed consent
* Clinical diagnosis of a non-penetrating traumatic SCI
* Asia Impairment Scale grade of A, B, or C

Exclusion Criteria:

1. Prior history of:

   * Brain injury
   * Recent or ongoing infection
   * Clinically significant cardiovascular, lung, renal, hepatic or endocrine disease,
   * Neurodegenerative disorders
   * Cancer
   * Immunosuppression as defined by WBC\<3,000 cells/ml at baseline screening,
   * HIV+
   * Chemical or ETOH dependency
2. Having a contraindication to MRI scans
3. Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation or HB-adMSC administration
4. Participation in other interventional research studies
5. Unwillingness to return for follow-up visits

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital-Clinical Research Unit (MMH-CRU)
state: Texas
Study officials:
References:
Clinical trial NCT06617949: Evaluating Pain Control Strategies in Postpartum Patients on Opioid Use Disorder Medications.
Official title: Evaluating Pain Control Strategies in Postpartum Patients on Opioid Use Disorder Medications: Efficacy and Safety Outcomes.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Substance Use Disorder (SUD)
Keywords: Pain conrtrol
Substance use disorder
Parturient
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy of three different modalities of post-operative pain control in parturient with opioid use disorders. The investigators aim to determine whether the different approach utilized show better outcomes with pain management and if there are any association with reduction of symptoms of anxiety, depression, and overall well-being.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria include being a parturient with Substance use disorder (SUD) and age 18-35

Exclusion Criteria:

* Exclusion criteria include having a diagnosed medical condition(allergies to medication, pathology such as severe aortic stenosis excluding patients from receiving an epidural etc) that will exempt patient from intervention arm of the study.

Primary outcomes:
measure: Number of participants with Change in pain assessment scores from baseline post surgery
timeFrame: immediately after the study intervention and up to post op day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital Milwaukee, Wisconsin 53226
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
Study officials:
References:
Clinical trial NCT00005249: Epidemiology of Blood Pressure, Insulin, Salt Transport
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
Obesity
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To determine the roles of insulin, lipids, body weight and ion transport in blood pressure regulation.

Detailed description: BACKGROUND:

Insulin levels are consistently related to blood pressure, obesity, and blood lipids. Insulin level correlation with sodium-lithium countertransport is limited to only one available study done in white, normotensive, predominantly normal weight women aged 45-52. The relationship between cellular sodium-hydrogen exchange activity and hypertension has been studied in rats and in a small study in humans. Correlation of this transport with weight, fasting insulin and lipid levels, and sodium-lithium countertransport was not available in 1989.

DESIGN NARRATIVE:

The study was cross-sectional. Subjects were stratified by weight: plus or minus 10 percent of desirable weight; 11 to 30 percent over desirable weight; and 30 percent over desirable weight; and by diastolic blood pressure: 80; 80-89; 90-99 mmHg. Blood pressure, height, weight, waist and hip girth, skinfold, fasting and post-glucose load insulin, glucose, lipids, creatinine, maximal rates of red blood cell sodium-lithium countertransport and platelet sodium-hydrogen exchange, pH, and calcium concentrations were measured. The strength and independence among these continuous variables were measured by Pearson correlations, partial correlations, and multiple regressions within each stratum, and if appropriate, over all strata. The study examined the hypotheses that: part of the relationship between obesity and blood pressure was due to insulin effects and/or lipid effects on ion transport; the relationship between ion transport and blood pressure was related to an abnormality of sodium-hydrogen exchange, for which the observed increase in sodium-lithium countertransport was a marker; increased blood pressure was related to the alteration of intracellular pH and/or calcium concentration.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bunker CH, Wing RR, Becker DJ, Kuller LH. Sodium-lithium countertransport activity is decreased after weight loss in healthy obese men. Metabolism. 1993 Aug;42(8):1052-8. doi: 10.1016/0026-0495(93)90022-g.
Clinical trial NCT03180749: Post-Marketing Clinical Follow-Up of a Spine Implant
Official title: Post-Marketing Clinical Follow-up of an Anular Closure System (Barricaid®) to Confirm Comparability of Outcome Between Devices With Subcomponents From Two Different Suppliers
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lumbar Disc Herniation
Annular Tear of Lumbar Disc
Lead sponsor: Intrinsic Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-06-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sites will enroll all eligible patients who were implanted with the Barricaid with an anchor of the second vendor (identifiable via the lot number), and consent to participate.

Brief summary: Post-Marketing Clinical Follow-up of an Anular Closure System (Barricaid®) to Confirm Comparability of Outcome between Devices with Subcomponents from Two Different Suppliers

Detailed description: Comparison of device integrity (anchor fracture and/or mesh detachment) and device movement/migration in patients implanted with the Barricaids with anchors from two different suppliers.

Eligibility criteria: Inclusion Criteria:

* Each site will enroll all patients who were implanted with a Barricaid with an anchor manufactured by the second manufacturer.
* Patients must be 18 years of age or older and able to understand and consent to participate in the study.

Exclusion Criteria:

* Not defined

Primary outcomes:
measure: Device failures
timeFrame: 22+ months post implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Bielefeld
country: Germany
facility: Wirbelsäulenzentrum Bielefeld
city: Itzehoe
country: Germany
facility: Klinikum Itzehoe
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Lingen
country: Germany
facility: Bonifatius Hospital Lingen
city: Steinfurt
country: Germany
facility: UKM Marienhospital Steinfurt
city: Sankt Gallen
country: Switzerland
facility: Orthopädie St.Gallen
Study officials:
References:
Clinical trial NCT03093649: Measuring Patient-Reported Adverse Events in Oncology Practice Improves Quality of Life in Nasopharyngeal Carcinoma
Official title: Measuring Patient-Reported Adverse Events in Oncology Practice Improves Quality of Life in Patients With Nasopharyngeal Carcinoma Undergoing Intensity Modulated Radiation Therapy: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasopharyngeal Neoplasms
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-03-28
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Although patient-reported adverse events have been promoted as an essential element in clinical trials and daily managements, their efficacy remained unknown. The purpose of this trial was to determine the effect of the patient-reported adverse events during the treatment on the improvements on quality of life.


Eligibility criteria: Inclusion Criteria:

* Patients with newly histologically confirmed non-keratinizing carcinoma (according to WHO histological type)
* No evidence of distant metastasis (M0)
* Performance status: PS 0\~2
* Receive standard treatment
* Able to read and understand the questionnaires
* Not exhibiting overt psychopathology
* Willing to give feedback to physicians and written informed consent was obtained

Exclusion Criteria:

* WHO type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
* Treatment with palliative intent.
* Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
* Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
* Patient is pregnant or lactating
* Severe intercurrent disease

Primary outcomes:
measure: Score of physical functioning in quality of life
timeFrame: within 1 week of study completion
Secondary outcomes:
measure: 3-year overall survival
timeFrame: 3 year after diagnosis
measure: 3-year progression-free survival
timeFrame: 3 year after diagnosis
measure: 3-year local-regional free survival
timeFrame: 3 year after diagnosis
measure: 3-year metastatic-free survival
timeFrame: 3 year after diagnosis
measure: completion rate
timeFrame: within 1 week of study completion
measure: degrees of patients satisfaction regarding the treatment process
timeFrame: within 1 week of study completion
measure: response rate
timeFrame: 1 month after study completion
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT01749449: Increased Dietary Protein and Meal Frequency Reduces Total and Abdominal Body Fat During Weight Maintenance and Weight Loss
Official title: Increased Protein Intake and Meal Frequency Reduces Abdominal Fat and Increases Postprandial Thermogenesis During Energy Balance and Energy Deficit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: high protein
high carbohydrate
meal frequency
abdominal body fat
postprandial thermogenesis
Lead sponsor: Skidmore College
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2012-12-13
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the current study was to examine the impact of macronutrient intake (PRO, 15% vs. 35%) and meal frequency (3 vs. 6 meals/day) on body composition, postprandial thermogenesis and plasma adipokines before and after 28days each of EB (28days) and ED (25%; 28days) in overweight individuals. We hypothesize that HP will elicit more favorable body composition, thermogenic, and cardiometabolic changes than HC intakes and the magnitude of change will be greatest in those consuming HP meals more frequently.


Eligibility criteria: Inclusion Criteria:

* 30-65 years old,
* overweight or obese but otherwise in good health

Exclusion Criteria:

* cardiovascular disease,
* cancer,
* HTN,
* type I or II DM,
* food allergies

Primary outcomes:
measure: body composition
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saratoga Springs
country: United States
facility: Skidmore College
state: New York
Study officials:
affiliation: Skidmore College
name: Paul J Arciero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00067249: Women's Use of Alternative Medicine: A Multiethnic Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Fibroids
Osteoporosis
Urinary Tract Infection
High Blood Pressure
Heart Disease
Arthritis
Depression
Headaches
Keywords: Race
Ethnicity
Complementary and Alternative Medicine
Women's health
Social determinants of Health
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-08-15
Enrollment: 3200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: NATURAL_HISTORY
Time perspective: OTHER

Brief summary: The purpose of this study is to examine socio-cultural factors of women's use of complementary and alternative medicine (CAM). The effects of socioeconomic status, social networks and acculturation on CAM use will be assessed among white, African-, Mexican-, and Chinese-American women.


Eligibility criteria: Inclusion criteria:

Experienced one or more of the following health conditions within the last year:

* pregnancy related symptoms
* menopausal related symptoms
* headaches
* back pain
* osteoporosis
* cancer
* high blood pressure
* high cholesterol
* heart disease
* joint pain/arthritis
* insomnia
* uterine fibroids
* urinary tract infection
* vaginal tract infection
* medically diagnosed depression
* menstrual symptoms

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rosenthal Center for Complementary and Alternative Medicine, Columbia University
name: Fredi Kronenberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00375349: Non Alcoholic Fatty Liver Disease Influence of Statin Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Non-alcoholic Fatty Liver Disease (NAFLD)
Keywords: fatty liver
statin
non-alcoholic
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2006-09-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Aim:

1. To determine the prevalence of fatty liver in a cohort of patients hospitalized with chest pain in the Cardiology department.
2. To assess the effect of statins on the prevalence of fatty liver by a cross sectional survey of patients hospitalized with chest pain.

Detailed description: Consecutive patients hospitalized with chest pain will be recruited at the cardiology department. Patients with an inflammatory condition, recent infection or history of alcoholism will be excluded. After signing an informed consent each patient will undergo an ultrasound examination for diagnosis of fatty liver. Information regarding BMI, hypertension and use of medications will be collected on each patient. Blood samples for fasting glucose, hemoglobin A1C, lipid profile, ESR, and CRP and liver function tests will be collected from each participant. Prevalence of fatty liver in patients who have been taking statins for 6 months or more statins will be compared to patients who have been taking statins for a lesser period and to those who do have not taken statins using a multivariate regression analysis.

Serum samples will be frozen and kept for future ongoing research.

Eligibility criteria: Inclusion Criteria:

* Cardiology patient
* Age above 18

Exclusion Criteria:

* Age below 18

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Antonopoulos S, Mikros S, Mylonopoulou M, Kokkoris S, Giannoulis G. Rosuvastatin as a novel treatment of non-alcoholic fatty liver disease in hyperlipidemic patients. Atherosclerosis. 2006 Jan;184(1):233-4. doi: 10.1016/j.atherosclerosis.2005.08.021. Epub 2005 Oct 5. No abstract available.
Clinical trial NCT06045949: Prediction of Early Recovery of Liver Function After LDLT in Children: An Ambispective Cohort Study
Official title: Prediction of Early Recovery of Liver Function After Living Donor Liver Transplantation in Children: An Ambispective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver and Biliary Tract Disorders in Duration of Pregnancy
Other End-stage Liver Diseases in Children
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 230
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators included children who underwent LDLT in this center from January 1, 2018 to June 30, 2023.

Brief summary: The investigators included children with living donor liver transplantation (LDLT) from January 1, 2018 to July 31, 2022 as a retrospective cohort, and the group from August 1, 2022 to June 30, 2023 as a prospective cohort. The investigators collected the demographic and clinicopathological data of donors and recipients, and determined the risk factors of early postoperative delayed recovery of hepatic function (DRHF) by univariate and multivariate Logical regression analyses.


Eligibility criteria: Inclusion Criteria:

1. children with the indication of LDLT \[cholestatic liver disease (such as BA), metabolic liver disease (such as Wilson's disease and Ornithine transcarbamylase deficiency), acute liver failure (such as drug induced), neoplastic disease (such as hepatoblastoma), vascular disease (such as cavernous transformation of portal vein and congenital absence of portal vein), re-transplantation and others\];
2. the relatives of the children voluntarily donated part of the liver which met the requirements of LDLT.

Exclusion Criteria:

1. recipients with contraindications of LDLT (such as coagulation dysfunction, acute infection, cardiopulmonary failure);
2. failure to complete LDLT due to various reasons (such as death during or within 3 days after operation);
3. recipients or donors with incomplete necessary data.

Primary outcomes:
measure: DRHF
timeFrame: 30 days after LDLT in children
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT03503149: Molecular Tumor Board at the Center for Personalized Medicine Tübingen
Official title: Molecular Tumor Board at the Center for Personalized Medicine Tübingen: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Cancer
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2018-04-19
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced stages of cancer

Brief summary: Molecular Tumor Board at the Center for Personalized Medicine

Detailed description: Molecular Tumor Board at the Center for Personalized Medicine The study objectives are

* To ensure a prospective documentation of all patients who are referred to the Molecular Tumor Board in routine clinical care
* To prospectively ensure the documentation of MTB patients with an emphasis to clinical outcome parameters progression-free survival (PFS), overall survival (OS) and further response assessments (e.g. peripheral immunmonitoring, imaging parameters)
* To prospectively assess patient-reported outcome of MTB patients
* To evaluate compliance to MTB suggestions in routine clinical care

Eligibility criteria: Inclusion Criteria:

* Given informed consent ("broad consent" of the University Hospital Tübingen)
* ≥ 18 years of age
* Clinical indication for a referral to Molecular Tumor Board by the treating physician

Exclusion Criteria:

* The MTB assists the referring physician with the interpretation and the use of tumor molecular profiling data for deciding on a therapeutic strategy. Therefore, this board is confined to cancer patients and cannot provide any service for non-cancer patients

Primary outcomes:
measure: Progression-free survival
timeFrame: 6 months
Secondary outcomes:
measure: Overall survival
timeFrame: an average of 1 year
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen
state: BW
Study officials:
affiliation: University Hospital Tübingen
name: Ghazaleh Tabatabai, Prof
role: PRINCIPAL_INVESTIGATOR
References: