louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02444273: The Feasibility of a Prehabilitation Program in the Liver Transplant Population at Barnes-Jewish Hospital
Official title: The Feasibility of a Prehabilitation Program in the Liver Transplant Population at Barnes-Jewish Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Liver Disease
Physical Activity
Keywords: liver diseases
liver transplantation
preoperative care
physical therapy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Barnes-Jewish Hospital
First posted: 2015-05-14
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary outcome of this study is to demonstrate the feasibility of a prehabilitation program at Barnes Jewish Hospital for liver transplant candidates. Those patients who consent to participate in the study and are placed on the transplant list will be randomized into either the control or intervention group. The intervention group receives a personalized home exercise program along with weekly phone calls to provide coaching, mentoring and motivation. Data collected at baseline, post-transplant and, post-transplant follow up will be compared among the two study groups. The secondary outcomes include: normative data of functional measures for patients with end stage liver disease and to determine the effect size for future research on prehabilitation in the patient population.


Eligibility criteria: Inclusion Criteria:

* Being evaluated for liver transplantation by Barnes Jewish Hospital medical team

Exclusion Criteria:

* Non-english speaking
* Medical contraindications to exercise as determined by the medical team

Primary outcomes:
measure: Feasibility of a prehabilitation program.
timeFrame: 2 Years
Secondary outcomes:
measure: Normative data on Timed Up and Go for patients with end stage liver disease.
timeFrame: Baseline
measure: Normative data on 10 meter walk for patients with end stage liver disease.
timeFrame: Baseline
measure: Normative data on Modified Dynamic Gait Index for patients with end stage liver disease.
timeFrame: Baseline
measure: Normative data on Five Time Sit to Stand for patients with end stage liver disease.
timeFrame: Baseline
measure: Normative data on 6 Minute Walk Test for patients with end stage liver disease.
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00817973: Differential Effects of Protein Quality on Postprandial Lipemia in Response to a Fat-Rich Meal in Type 2 Diabetes: Comparison of Whey, Casein, Gluten, and Cod Protein
Official title: Differential Effects of Protein Quality on Postprandial Lipemia in Response to a Fat-Rich Meal in Type 2 Diabetes: Comparison of Whey, Casein, Gluten, and Cod Protein
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Postprandial Lipemia
Keywords: Whey protein
gluten
casein
cod protein
GLP-1
postprandial
triglyceride
free fatty acids
chylomicrons
retinyl palmitate
type 2 diabetes
GIP
Postprandial incretins
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: The Danish Obesity Research Centre
name: Nordic Centre of Excellence
First posted: 2009-01-07
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Enhanced and prolonged postprandial triglyceride responses involve increased cardiovascular risk in type 2 diabetes. It has been demonstrated that dietary fat and carbohydrates profoundly influence postprandial hypertriglyceridemia in type 2 diabetes, whereas little information exists about the effect of proteins.

The purpose of this study is to compare the effects of the proteins casein, whey, cod, and gluten on postprandial lipid and incretin responses to a high-fat meal in type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Diabetes

Exclusion Criteria:

* Liver, Kidney- and/or Heart Disease
* Serious Hypertension (160/110 mmHg)

Primary outcomes:
measure: Triglyceride levels
timeFrame: 0h- 2h- 4h- 6h- 7h- 8h postprandial
Secondary outcomes:
measure: Incretin levels
timeFrame: 0h- 0.5h- 1h- 2h- 4h- 6h- 8h postprandial
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Clinical Nutrition
Study officials:
affiliation: Department of Endocrinology and Metabolism
name: Kjeld Hermansen, Professor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mortensen LS, Thomsen C, Hermansen K. Effects of different protein sources on plasminogen inhibitor-1 and factor VII coagulant activity added to a fat-rich meal in type 2 diabetes. Rev Diabet Stud. 2010 Fall;7(3):233-40. doi: 10.1900/RDS.2010.7.233. Epub 2010 Nov 10.
citation: Mortensen LS, Hartvigsen ML, Brader LJ, Astrup A, Schrezenmeir J, Holst JJ, Thomsen C, Hermansen K. Differential effects of protein quality on postprandial lipemia in response to a fat-rich meal in type 2 diabetes: comparison of whey, casein, gluten, and cod protein. Am J Clin Nutr. 2009 Jul;90(1):41-8. doi: 10.3945/ajcn.2008.27281. Epub 2009 May 20.
Clinical trial NCT01386073: Efficacy of FreshKote and Systane for the Treatment of Dry Eye and Improvement of Osmolarity
Official title: Efficacy of FreshKote and Systane for the Treatment of Dry Eye and Improvement of Osmolarity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dry Eye
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2011-06-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of FreshKote and Systane for the reduction of dry eye signs and symptoms.


Eligibility criteria: Inclusion Criteria:

* Dry eye patients with Level 2 disease or greater as defined by the Delpi Panel
* Tear osmolarity of at least 308 mosm
* At least 18 years of age, Male or Female
* Willing to provide written informed consent
* Likely to complete all study visits
* If currently using ocular lubricants, must complete a 10-14 day washout

Exclusion Criteria:

* Presence of any active ocular disease other than dry eye
* Use of topical ophthalmic medications
* Use of contact lenses during the trial
* Pregnant or nursing, or planning a pregnancy. Patients will be asked if they are pregnant or may be pregnant and excluded if they answer in the affirmative.
* Any known sensitivity to any ingredients of either study drop
* Oral anti-inflammatory medications, omega 3 supplements, or doxycycline
* Punctal plugs inserted within the last 6 months or less
* Uncontrolled systemic disease
* Subjects with known sensitivity or inappropriate responsiveness to any of the medications used.
* Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised, etc.)
* Corneal abnormalities (e.g., ecstatic diseases, degenerations, or corneal dystrophies of the stroma or endothelium)
* Concurrent participation or participation in the last 30 days in any other clinical trial

Primary outcomes:
measure: TBUT
timeFrame: Three months
measure: Best Corrected Visual Acuity
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Lake Villa
country: United States
facility: Jackson Eye, S.C
state: Illinois
city: Chesterfield
country: United States
facility: Pepose Vision Institute
state: Missouri
Study officials:
affiliation: Pepose Vision Institute
name: Jay Pepose, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jackson Eye, S.C
name: Mitch Jackson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06306573: CardioMEMS HF System Real-World Evidence Post-Approval Study
Official title: CardioMEMS™ HF System Real-World Evidence Post-Approval Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Heart Failure NYHA Class II
Heart Failure NYHA Class III
Keywords: CardioMEMS HF System
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2024-03-12
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The intended population for this RWE PAS includes Medicare FFS beneficiaries with symptomatic NYHA Class II and III heart failure implanted with a CardioMEMS PA Sensor in the commercial setting.

Brief summary: The purpose of this post-approval study (PAS) is to evaluate the long-term safety and effectiveness of the CardioMEMS™ HF System using real-world evidence (RWE) methods.

Detailed description: Subjects will be identified in Abbott's Merlin.net remote monitoring database. Merlin.net data will be linked to Medicare fee-for-service (FFS) claims data to longitudinally track outcomes. Each subject will be followed for a minimum of 36 months.

Eligibility criteria: Inclusion Criteria:

* Subject implanted with a CardioMEMS PA Sensor and enrolled in Merlin.net
* Subject resides in the United States as documented in Merlin.net
* NYHA Class II or Class III as documented in Merlin.net at the time of CardioMEMS implant (only NYHA Class II subjects contribute to the Primary Cohort)
* Subject identified in Merlin.net data can be linked to Medicare FFS claims
* Subject is enrolled in Medicare Part A and B, and not enrolled in Medicare Part C, at implant and for 12 months prior to implant, to establish qualification for CardioMEMS
* Subject ≥18 years of age at time of CardioMEMS implant

Exclusion Criteria:

* Subject received heart transplant or durable mechanical circulatory support device implant (i.e., left/right/bi-ventricular assist device) prior to CardioMEMS implant

Primary outcomes:
measure: Two-Year Survival in the Primary Cohort (NYHA Class II subjects)
timeFrame: 2 years
Secondary outcomes:
measure: Two-Year Survival in the Full Cohort (NYHA Class II and Class III subjects)
timeFrame: 2 years
Other outcomes:
measure: 3-Year Survival
timeFrame: 3 years
measure: HF Hospitalization Rate
timeFrame: 3 years
measure: Pulmonary Artery (PA) Pressures Measured by the CardioMEMS PA Sensor
timeFrame: 3 years
measure: Subject Compliance Rates with Weekly Pulmonary Artery (PA) Pressure Uploads
timeFrame: 3 years
measure: Number of Subjects with Heart Failure (HF) Prescription Medication Fills
timeFrame: 3 years
measure: Proportion of Subjects with Heart Failure (HF) Prescription Medication Fills
timeFrame: 3 years
Locations:
city: Atlanta
country: United States
facility: Abbott Medical
state: Georgia
Study officials:
References:
Clinical trial NCT00810173: Phone Call in Type 2 Diabetes Patient
Official title: Phone Call as an Intervention for Improving Walking Practice in Type 2 Diabetes: Influence of Personality Profile in This Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior Change
Keywords: type 2 diabetes
physical activity
behavior change
profile personality
phone call support
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2008-12-17
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To assay the influence of personality profile to promote behavior change adherence for physical activity using a pedometer. The investigators also studied the metabolic profile, diagnosis of depression, intention to change behavior, physical activity referred and the quality of life. Casuistic and Methods: a randomized "quasi-experimental" enrolling 48 T2DM patients using a pedometer for 6 weeks. The intervention group received phone calls stimulating them to increase their walking activity. The control group received only one telephone call to explain pedometer use. The investigators also analyzed the personality profile, quality of life, and metabolic and anthropometric indexes.


Eligibility criteria: Inclusion Criteria:

* to assign written informed consent
* to have a phone call number
* to agree to use a pedometer for 6 weeks to be able to write the data concerning their number of steps per day

Exclusion Criteria:

* don´t agree to assign written informed consent
* don´t have phone number
* don´t have conditions to answer all the questionnaire
* don´t agree to use pedometer for 6 weeks

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02688673: DC Vaccine Combined With CIK Cells in Patients With SCLC
Official title: Safety and Therapeutic Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Extensive-Stage Small- Cell Lung Cancer: a Phase I/II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Small- Cell Lung Cancer
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the safety and efficacy of dendritic cells (DC) combined with cytokine-induced killer (CIK) cells treatment patients with Extensive-Stage Small-Cell Lung Cancer. Experimental adopted recombinant adenovirus-code MUC1 and Survivin transfected DC, which are used for DC-based immunotherapy. Based on the results of our previously preclinical research with DC combined with CIK cells, the investigators plan to perform the clinical trial.


Eligibility criteria: Inclusion Criteria:

* Histopathologically confirmed diagnosis of Small- Cell Lung Cancer
* Age \>18 years at time of consent
* Received standardized treatment of Small-Cell Lung Cancer
* Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks
* KPS (Karnofsky performance scale) \>60
* Patient's written informed consent
* No severe viral or bacterial infections
* Predicted survival \>3 months

Exclusion Criteria:

* Clinically relevant diseases or infections (HBV, HCV, HIV)
* Females who are pregnant or nursing
* Immunosuppressant treatment
* Currently participating in another clinical trial
* Unfit for participating in this clinical trial in investigators' opinions

Primary outcomes:
measure: objective rate response (CR+PR) as measured by RECIST criteria
timeFrame: 4 weeks after DC/CIK treatment]
Secondary outcomes:
measure: number of participants with adverse events
timeFrame: 3 days within DC/CIK treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01418573: Glycemic Response After Palaeolithic-type Meals
Official title: Glycemic Response After Two Palaeolithic-type Meals Compared to a Modern-type Meal Composed According to WHO Guidelines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Index of a Meal
Keywords: glucose, insulin, post prandial
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
Collaborators: name: Leatherhead Food Research
First posted: 2011-08-17
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the study is to show post-prandial benefits of Palaeolithic-type meals as compared to a meal constructed along the lines of the WHO dietary recommendations.

Detailed description: The effects of this set of meals will be assessed with respect to blood

* blood glucose
* plasma insulin
* satiety scores
* plasma gut hormones It is hypothesised that lower post prandial blood glucose concentration, a lower insulin response and increased satiety will be seen after the Palaeolithic meals compared with a reference meal

Eligibility criteria: Inclusion Criteria:

* male
* ≥ 18 and ≤ 60 years old
* Body mass index (BMI) ≥ 18 and ≤ 27.0 kg/m2
* Apparently healthy
* Not smoking
* A fasting blood glucose value within the normal reference value

Exclusion Criteria:

- No prescribed medication

Primary outcomes:
measure: Blood glucose
timeFrame: 0-2 hours
measure: Plasma insulin
timeFrame: 0-2 hours
measure: Peak blood glucose
timeFrame: 0-2 hours
Secondary outcomes:
measure: Satiety scores
timeFrame: 0-2 hours
measure: Gut hormone panel
timeFrame: 0-3 hours
Other outcomes:
Locations:
city: Leatherhead
country: United Kingdom
facility: Leatherhead Food Research
state: Surrey
Study officials:
affiliation: Leatherhead Food Research
name: Sonia Pombo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frassetto LA, Schloetter M, Mietus-Synder M, Morris RC Jr, Sebastian A. Metabolic and physiologic improvements from consuming a paleolithic, hunter-gatherer type diet. Eur J Clin Nutr. 2009 Aug;63(8):947-55. doi: 10.1038/ejcn.2009.4. Epub 2009 Feb 11.
citation: Jonsson T, Granfeldt Y, Ahren B, Branell UC, Palsson G, Hansson A, Soderstrom M, Lindeberg S. Beneficial effects of a Paleolithic diet on cardiovascular risk factors in type 2 diabetes: a randomized cross-over pilot study. Cardiovasc Diabetol. 2009 Jul 16;8:35. doi: 10.1186/1475-2840-8-35.
citation: Bligh HF, Godsland IF, Frost G, Hunter KJ, Murray P, MacAulay K, Hyliands D, Talbot DC, Casey J, Mulder TP, Berry MJ. Plant-rich mixed meals based on Palaeolithic diet principles have a dramatic impact on incretin, peptide YY and satiety response, but show little effect on glucose and insulin homeostasis: an acute-effects randomised study. Br J Nutr. 2015 Feb 28;113(4):574-84. doi: 10.1017/S0007114514004012. Epub 2015 Feb 9.
Clinical trial NCT02406573: A Pilot Study to Assess Nominal Versus Controlled Stimuli on Dentinal Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Keywords: Sensitivity
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2015-04-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot study will evaluate the use of nominal stimuli to assess dentinal hypersensitivity response relative to a clinically-controlled stimulus.


Eligibility criteria: Inclusion Criteria:

* be at least 18 years of age
* sign an informed consent form and be given a copy
* be in good general health as determined by the Investigator/designee
* agree to delay any elective dentistry, including dental prophylaxis, and to report any dentistry received during the course of the study
* agree to not participate in any other oral care study for the duration of this study
* agree to return for scheduled visits and follow all study procedures
* have dentinal hypersensitivity with at least one tooth with a Schiff sensitivity score of at least 1 in response to the examiner applied cold water challenge

Exclusion Criteria:

* severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
* active treatment for periodontitis
* any diseases or conditions that might interfere with the subject safely completing the study
* inability to undergo study procedures
* fixed facial orthodontic appliances
* a history of kidney stones
* self-reported pregnancy or nursing
* known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate

Primary outcomes:
measure: Change From Baseline for Visual Analog Scale - Cold Water
timeFrame: Day 1
measure: Change From Baseline for Dentin Sensitivity Cold Water as Assessed by the Schiff Index
timeFrame: Day 1
measure: Change From Baseline for 5 Face Emoticon Scale
timeFrame: Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Mason
country: United States
facility: Oral Health Science Center
state: Ohio
Study officials:
affiliation: Procter and Gamble
name: Robert W Gerlach, DDS, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05509673: Lipofilling for Healing of Chronic Wounds
Official title: Clinical Trial to Improve Wound Healing of Chronic Lower Leg Ulcers by Autologous Transplantation of Fat Tissue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Healing Disorder
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
Collaborators: name: Cologne-Merheim Medical Center (CMMC)
First posted: 2022-08-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chronic wounds remain a therapeutic and financial challenge for physicians and the health care systems. Innovative, cheap and effective treatment methods would be of immense value. The sublesional fat grafting could be such treatment, although the effectiveness and safety have not been assessed in large randomized clinical trials. The aim of this trial was to analyse the effect of adipose tissue on the healing of chronic lower leg wounds. For this purpose, the wounds were surgically cleaned (wound debridement) and then fat was suctioned out from the stomach or thighs and then injected into the edges of the wound and under the wounds. The wounds are covered with a foam dressing that is changed every 3-4 days. There are controls on days 3, 7, 14 and 21 after the intervention and a follow-up examination 2 months after the intervention. The primary objective is the reduction of the wound area 14 days and 2 month after intervention. Secondary objectives are pain level of the wound, bacterial colonialisation of the wound and analysis of the grafted fat tissue (ammount of mesenchymal stem cells)


Eligibility criteria: Inclusion Criteria:

* Patients with leg ulcers of any origin (venous, arterial, mixed arterial-venous, diabetogenic, compressive)
* Age of ulcer \> 6 weeks
* Ulcer size \>= 1 cm (minimum diameter)
* Ulcer / wound with complete destruction of the epidermis (including basement membrane)
* Patient age \> 18 years
* Patient Consent

Exclusion Criteria:

* Pregnancy
* Exposed tendons, ligaments, or bone if maximum diameter \> 2 mm
* Ulcer size \> 10 cm
* Immediately preceding vacuum bandage therapy (\< 2 weeks)
* Possibilities for correcting the cause of the ulcer

Primary outcomes:
measure: Reduction of wound area
timeFrame: 14 days and 2 month
Secondary outcomes:
measure: Pain wound
timeFrame: 2 month
measure: Bacterial contamination wound
timeFrame: 3 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Witten/Herdecke
name: Oliver C Thamm, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: