louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00179153: Improving The Nutritional Status Of The Malnourished Chronic Hemodialysis Patients In The State Of Tennessee
Official title: Improving The Nutritional Status Of The Malnourished Chronic Hemodialysis Patients In The State Of Tennessee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End Stage Renal Disease
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We propose to identify malnourished chronic kidney dialysis patients through a statewide effort and subsequently treat them based on a protocol (provision of oral nutritional supplementation) over a period of six (6) months.


Eligibility criteria: Inclusion Criteria:

* On CHD dialysis for more than 6 months
* Adequately dialyzed (Kt/V \> 1.0) with a biocompatible hemodialysis membrane. Patients with Kt/V \> 1.0 but \< 1.4 will be evaluated for etiologies of lower than optimal dialysis dose and every effort will be made to increase the Dialysis dose to 1.4 or above. Patients with all access types will be recruited to the study.
* Suboptimal nutritional status identified by one of the following criteria:

  1. Protein catabolic rate less than 1.0 g/kg/d calculated by three-point urea kinetic modeling on at least 2 occasions over the past 3 months
  2. Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight and/or patients who are less than 90% of ideal body weight.
  3. Biochemical parameters of malnutrition defined by one of the following measurements over the consecutive two months prior to inclusion:

     1. Serum albumin less than 4.0 g/dl
     2. Serum transferrin concentration less than 250 mg/dl
     3. Serum prealbumin concentration less than 32 mg/dl
  4. Subjective Global Assessment Score less than 5.

Exclusion Criteria:

* Intolerance to nutritional supplementation (unable to tolerate any of the nutritional supplements available)
* Refusal to sign a consent form
* On nutritional supplementation (IDPN or PO) within 2 weeks of the study initiation.

Primary outcomes:
measure: increase in serum albumin
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: National Kidney Foundation
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Alp Ikizler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06057753: MyStroke in Chronic Stroke
Official title: Personalized Video-based Education for Chronic Stroke Survivors: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-center randomized control trial assessing the impact of a personalized video-based educational platform on patients satisfaction and stroke knowledge in the context of chronic stroke.


Eligibility criteria: Inclusion Criteria:

1. History of ischemic stroke between 1 and 10 years prior to enrollment
2. Receiving outpatient stroke care at the Hospital of the University of Pennsylvania
3. At least 18 years old
4. Access to a smart phone, tablet, or computer
5. Willingness to complete 2 follow-up surveys (7 days and 90 day post-enrollment)

Exclusion Criteria:

1. Unwilling or unable to access the customized app with a smartphone, tablet, or computer
2. Complete dependence on caregiver for all activities of daily living
3. Stroke occurred less than 1 year or greater than 10 years prior to screening/enrollment
4. Patient has severe aphasia (score of greater than or equal to 2 on National Institutes of Health Stroke Scale item 9)

Primary outcomes:
measure: Patient satisfaction with stroke education (90 days)
timeFrame: 90 days
measure: Stroke etiology recognition (90 days)
timeFrame: 90 days
measure: Stroke risk factor recognition (90 days)
timeFrame: 90 days
Secondary outcomes:
measure: Stroke prevention medication recognition (7 days)
timeFrame: 7 days
measure: Stroke prevention medication recognition (90 days)
timeFrame: 90 days
measure: Patient satisfaction with stroke education (7 days)
timeFrame: 7 days
measure: Stroke etiology recognition (7 days)
timeFrame: 7 days
measure: Stroke risk factor recognition (7 days)
timeFrame: 7 days
measure: Stroke patient education retention (SPER) survey (7 days)
timeFrame: 7 days
measure: Stroke patient education retention (SPER) survey (90 days)
timeFrame: 90 days
measure: EuroQOL - visual analog scale (7 days)
timeFrame: 7 days
measure: EuroQOL - visual analog scale (90 days)
timeFrame: 90 days
measure: modified Rankin Scale
timeFrame: 90 days
measure: Medication adherence (7 days)
timeFrame: 7 days
measure: Medication adherence (90 days)
timeFrame: 90 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05757453: Boost Study 31380 (mHealth)
Official title: BoostOne Study (MHealth)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Addiction
Lead sponsor: NXTech
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2023-03-07
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to examine the potential for a new software-based behavioral support approach, for individuals with opioid use disorder, as an addition to usual care.

Detailed description: The purpose of this study is to examine the potential for a novel computer-based approach to mitigate the symptoms of opioid use disorder as part of a comprehensive treatment program. The study is designed as a single-arm field-test of cognitive training for individuals under supervised medical treatment for opioid use disorder. A custom and proprietary smartphone package (mHealth platform) comprises the intervention available to enrolled subjects for interaction over the study period. Commercial mobile devices serve as information presentation and data recording instruments. Additional outcome measures incorporate subject-reported data.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* Diagnosis of opioid use disorder
* Experiencing symptoms multiple times per week
* Familiar with smartphone usage

Exclusion Criteria:

- None specified

Primary outcomes:
measure: Interaction Engagement, as Assessed by Interactions Completed
timeFrame: At 8 weeks
Secondary outcomes:
measure: Intervention Usability Rating, as Assessed by Likert User Experience Scale
timeFrame: At 8 weeks
measure: Treatment Progress Measure, as Assessed by TEA Score
timeFrame: At 8 weeks
Other outcomes:
Locations:
city: Astoria
country: United States
facility: PHNY
state: New York
Study officials:
affiliation: PHNY
name: Alexis Vien, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04794153: Investigating the Consumption of Different Protein Rich Whole Food Sources on Muscle Growth in Trained Males and Females
Official title: Assessing the Muscle Protein Synthetic Response Following the Ingestion of a Variety of Protein Rich Whole Foods Compared to an Isolated Protein Source.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Intervention Using Protein Rich Whole Food Sources
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: Marlow Foods Ltd
First posted: 2021-03-11
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Background To date, most of the literature investigating the role of dietary protein in muscle growth has focused on isolated protein sources. However, dietary protein is most commonly consumed within a whole food source. Consuming dietary protein within a whole food matrix may additionally stimulate muscle growth. The idea being, there may be other components within food, capable of producing a greater response.

Objectives: To assess the effect of consuming a variety of whole food sources, on the stimulation of muscle growth compared to an isolated protein source following a single bout of lower body resistance exercise.

Methods Young healthy resistance-trained volunteers will consume a protein rich whole food source, following a bout of lower body resistance exercise. Stable isotope IV infusions and repeated blood and muscle samples will be taken to assess protein digestion and absorption, as well as muscle protein synthesis rates.

Value of Research:

To determine whether whole food sources potentiate muscle protein synthesis rates (and to what extent across whole food sources) compared to an isolated protein source. In doing so, we can further investigate the nutrients involved that may be contributing to this effect.


Eligibility criteria: Inclusion Criteria:

* Males and Females
* BMI 18.5 - 30 kg/m2
* Aged 18 - 40 years
* Structured Resistance training consistently for \> 6 months
* A 5-7 day "washout" period from any supplementation

Exclusion Criteria:

* Age \>40 years
* Body mass index (BMI) \<18.5 or \>30 kg/m2
* Any metabolic impairments
* Any cardiovascular impairments
* High blood pressure (≥140/90 mmHg)
* Any gastrointestinal disorders
* Any medications known to affect protein and/or amino acid metabolism
* A personal or family history of epilepsy, seizures or schizophrenia, motor disorder
* Chronic over the counter use of pharmaceuticals (\> 1 month)
* Allergic to any of the whole foods included in the study

Primary outcomes:
measure: Postprandial Muscle protein Synthetic Response following the ingestion of a protein rich whole food source.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
state: Devon
Study officials:
affiliation: University of Exeter
name: Professor Wall
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00218153: Naltrexone Augmentation of Nicotine Patch Therapy - 1
Official title: Naltrexone Augmentation of Nicotine Patch Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tobacco Use Disorder
Keywords: nicotine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2005-09-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Naltrexone Augmentation of Nicotine Patch Therapy

Detailed description: This double blind placebo controlled study is designed to determine whether naltrexone can be used to help reduce cigarette use and craving for cigarettes. Eligible participants will receive 21mg transdermal nicotine as an outpatient. In addition, participants will receive one of three doses of naltrexone (25,50 or 100mg) or a placebo and brief counseling over the course of six weeks with follow-up appointments three, six, and twelve months after the beginning of treatment.

Eligibility criteria: Inclusion Criteria:

1. Age 18 and older
2. Willingness and ability to give written consent
3. Smoking 20 cigarettes per day for at least 1 year
4. At least one prior attempt to stop smoking
5. Baseline expired carbon-monoxide level of at least 10 ppm
6. Weigh at least 100 lbs.
7. English speaking
8. One person per household

Exclusion Criteria:

1. Pregnant or nursing women or women who do not use a reliable form of birth control
2. Unstable cardiac disease
3. History of dermatoses
4. Current alcohol dependence
5. Current use of opiates
6. A urine drug screen that is positive for opiates
7. Serious current neurologic, psychiatric or medical illness
8. Chronic pain conditions necessitating opioid treatment
9. Evidence of significant hepatocellular injury as evidence by SGOT or SGPT \>3 x normal or elevated bilirubin
10. Current use of smokeless tobacco, pipes, cigars, nicotine gum or nicotine patch
11. Patients requiring concomitant therapy with any psychotropic drug or on any drug with a psychotropic component

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Substance Abuse Treatment Unit
state: Connecticut
city: New Haven
country: United States
facility: VA Connecticut Health Care System
state: Connecticut
Study officials:
affiliation: Substance Abuse Treatment Unit
name: Stephanie O'Malley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: King AC, Cao D, Zhang L, O'Malley SS. Naltrexone reduction of long-term smoking cessation weight gain in women but not men: a randomized controlled trial. Biol Psychiatry. 2013 May 1;73(9):924-30. doi: 10.1016/j.biopsych.2012.09.025. Epub 2012 Nov 22.
citation: O'Malley SS, Krishnan-Sarin S, McKee SA, Leeman RF, Cooney NL, Meandzija B, Wu R, Makuch RW. Dose-dependent reduction of hazardous alcohol use in a placebo-controlled trial of naltrexone for smoking cessation. Int J Neuropsychopharmacol. 2009 Jun;12(5):589-97. doi: 10.1017/S146114570800936X. Epub 2008 Sep 17.
Clinical trial NCT04161053: Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy
Official title: Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hepatic Encephalopathy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Efficacy and Safety of Nitazoxanide in preventing recurrence of Hepatic Encephalopathy.

Detailed description: Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in preventing recurrence of Hepatic Encephalopathy.

Eligibility criteria: Inclusion Criteria:

* Cirrhotic patient with at least one previous episode of hepatic encephalopathy.
* Adult Patients aging from 20 to 65 years old

Exclusion Criteria:

* Active GIT bleeding.
* Major psychiatric illness (psychosis \& epilepsy).
* Renal insufficiency (S.Cr 2mg/dl).

Primary outcomes:
measure: Number of encephalopathy episodes during treatment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Tanta University
name: Khadija Ahmed Glal, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta University
name: Tarek Mohamed Mostafa, ass, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta University - Tropical Medicine Department
name: Sherief Abd-Elsalam, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00358553: A Crossover Study Assessing the Pharmacokinetics, Pharmacodynamics, and Safety of Recombinant Human Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Human Volunteers
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2006-08-01
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, and safety of recombinant human insulin. The study will consist of 2 phases.


Eligibility criteria: Inclusion Criteria:

* Healthy Male Subjects
* Age between 18 and 40 years of age

Exclusion Criteria:

* History of Diabetes
* Subjects with clinically significant active disease
* Known allergy to insulin

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil
Study officials:
affiliation: Profil Institute
name: Tim Heise, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03121053: Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement
Official title: Preventing Contrast Induced Nephropathy After Transcatheter Aortic Valve Replacement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Aortic Valve Disease
Chronic Kidney Disease
Contrast Induced Nephropathy
Acute Kidney Injury
Keywords: transcatheter aortic valve implantation
transcatheter aortic valve replacement
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Chronic kidney disease (CKD) and (subsequent) acute kidney injury are frequent in patients undergoing transcatheter aortic valve implantation (TAVI). Moreover, these patients are easily hypervolemic and susceptible for cardiac decompensation. Prevention of contrast induced nephropathy (CIN) has not yet been studied in these patients, and evidence on different strategies is urgently needed. The objective of this study is to evaluate the efficacy of 250ml 1.4% sodium bicarbonate versus hypotone saline (0.65% sodiumchloride) hydration prior to TAVI in patients with CKD to prevent CIN.


Eligibility criteria: Inclusion Criteria:

1. Patient has provided written informed consent.
2. Patient is undergoing TAVI.
3. Patient has an estimated GFR \<60ml/min/1.73m2.

Exclusion Criteria:

1. Patient has end-stage kidney disease requiring dialysis.
2. Emergent TAVI (planned before next working day).
3. Recent exposure to radiographic contrast agents (within 2 days prior to the TAVI).
4. Allergy to contrast agent.
5. Planned administration of dopamine, mannitol, fenoldopam or N-acetylcysteine during the intended time of the study.
6. Need for continuous hydration therapy (e.g. sepsis).
7. Multiple myeloma.
8. Contra-indication to sodium bicarbonate.

Primary outcomes:
measure: Contrast induced nephropathy
timeFrame: Day 3
measure: Acute heart failure due to volume expansion
timeFrame: Day 3
Secondary outcomes:
measure: Composite of CIN or acute heart failure
timeFrame: Day 3
measure: Maximal relative change in serum creatinine
timeFrame: Day 3
measure: Acute kidney injury
timeFrame: Day 3
measure: Need for dialysis
timeFrame: Day 30
measure: Need for blood transfusions
timeFrame: Day 3 and Day 30
measure: Number of blood transfusions
timeFrame: Day 3 and Day 30
measure: Length of hospital stay
timeFrame: Day 30
measure: Recovery of renal function in CIN patients
timeFrame: Day 30
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St Antonius hospital
state: Utrecht
Study officials:
References:
Clinical trial NCT01653353: Swiss Study on Vitamin D and Calcium in Nursing Homes
Official title: Swiss Study on Vitamin D and Calcium in Nursing Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Vitamin Deficiency
Keywords: nursing home
vitamin D supplements
calcium supplements
guideline adherence
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2012-07-31
Enrollment: 71
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Residents of nursing homes are endangered by malnutrition and vitamin D deficiency. Our study checks compliance with Swiss federal recommendations on vitamin D and calcium supplementation among residents of a Swiss nursing home. A peer physician-applied recommendation on compliance with the federal recommendations with individual evaluation of the residents will be sent to the physicians in care. After one year, data will be collected again.

Detailed description: The investigators plan to get a complete sample of all inhabitants, so the only inclusion criterion is to get an informed consent either from the residents or from their relatives. The following data will be recorded: Year of birth, gender, height, weight, blood pressure and heart rate, daily calcium intake from diet, nursing home scales on pain, depression, dementia and activities of daily life, date of entry to the home, diagnosis and medication lists. From a venous blood sample the investigators get: calcium, phosphate, albumin, creatinin, 25-hydroxyvitamin D, parathormone (intact).

Primary endpoint: Proportion of medication lists of residents complying with federal recommendation on vitamin D and calcium supplementation.

Secondary endpoints: 25-hydroxyvitamin D levels, effect of an intervention with a nursing home-applied recommendation to the physicians.

Eligibility criteria: Inclusion Criteria:

* Resident of nursing home on qualifying date
* Written informed consent by residents or their relatives

Exclusion Criteria:

* Refusion of participation

Primary outcomes:
measure: Proportion of compliance with federal recommendations
timeFrame: up to 12 months
Secondary outcomes:
measure: 25-hydroxyvitamin D serum levels
timeFrame: up to 12 months
measure: Effect of nursing home-applied recommendations to physicians
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Arbon
country: Switzerland
facility: Pflegeheim Sonnhalden
state: TG
Study officials:
affiliation: University of Zurich
name: Markus P. Gnädinger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Zurich
name: Heike A. Bischoff-Ferrari, MD, DrPH, Prof
role: STUDY_DIRECTOR
affiliation: University of Zurich
name: Andreas Egli, MD
role: STUDY_CHAIR
References: