louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03412825: Diet, Nutrient Status, and Food Insecurity
Official title: The Effect of Dietary Supplementation on Nutrient Status in Families Living in a Food Insecure Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Insecurity
Lead sponsor: University of Arkansas, Fayetteville
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Arkansas has one of the highest rates for food insecurity and 27.7% of children in the University of Arkansas area are food insecure. In addition, more than 14% of children ages 2-4 are obese and 20% of children ages 10-17 are obese. In Northwest Arkansas, the area surrounding the University of Arkansas in Fayetteville (Washington County), the food insecurity rate for adults is 17.9% (an estimated 34,730 individuals) and the food insecurity rate for children under 17 years of age is 24.4% (12,150 individuals). In addition, the surrounding counties have similar food insecurity rates (This makes Northwest Arkansas an ideal location to conduct a pilot study focusing on egg supplementation, childhood obesity, and food insecurity (http://www.feedingamerica.org/hunger-in-america/our-research/map-the-meal-gap).


Eligibility criteria: Inclusion Criteria:

* Food insecurity assessed by use of SNAP benefits or qualifying using the US Food Security Scale).

Exclusion Criteria:

* No dietary restrictions
* Fear of needles
* Metabolic disorders
* Picky eating
* Taking medication

Primary outcomes:
measure: Micronutrient status in plasma
timeFrame: The change in micronutrient status (e.g. iron, vitamin A, vitamin B12) will be measured from baseline to 16 weeks to determine if the dietary intervention improves baseline micronutrient status.
measure: Body composition
timeFrame: The change in body composition (e.g. ratio of lean to fat mass) will measured from baseline to 16 weeks.
Secondary outcomes:
measure: Height
timeFrame: The change in height will be measured from baseline to 16 weeks.
measure: Weight
timeFrame: The change in weight will be measured from baseline to 16 weeks.
measure: Waist-to-hip ratio
timeFrame: The change in waist-to-hip ratio will be measured from baseline to 16 weeks.
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas
state: Arkansas
Study officials:
affiliation: University of Arkansas, Fayetteville
name: Jamie I Baum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04226625: Effects of Desflurane and Propofol During Lung Volume Reduction Surgery
Official title: A Comparison of the Anesthetic and Hemodynamic Effects of a Volatile Anesthetic (Desflurane) and an Intravenous Anesthetic (Propofol), During Lung Volume Reduction Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lung Volume Reduction Surgery
Keywords: Anesthesia
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomized to receive propofol or desflurane as the maintenance anesthetic.
Primary purpose: OTHER

Brief summary: Patients presenting for lung volume reduction are very high risk patients and it is important they receive the best anesthetic available. This study aims to answer which is the best anesthetic for managing such cases.

Detailed description: The anesthetic technique for lung volume reduction surgery consists of a thoracic epidural in combination with a general anesthetic. The thoracic epidural is routine for this operation and allows administration of local anesthetics and painkillers in the epidural space which results in profound pain relief in the area of surgery. The epidural is routinely used for pain control during the surgery and after the surgery when the patient is awake.

The general anesthetic used may be a volatile agent (gas for example Desflurane), which is administered through the anesthesia machine, or an intravenous anesthetic agent, which is administered into a vein through an intravenous line as a continuous infusion (example Propofol). The use of an anesthetic agent and an epidural often causes a decrease in blood pressure which is treated with medication. The investigators are comparing the two anesthetic techniques regarding their effect on blood pressure and the amount of medication needed to treat it.

Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo lung volume reduction surgery (LVRS)

Exclusion Criteria:

* Does not sign a study consent form

Primary outcomes:
measure: Time of discontinuation of anesthetic to eye opening
timeFrame: Up to 30 minutes (during procedure)
measure: Time of discontinuation of anesthetic to tidal volume (TV) 300ml
timeFrame: Up to 30 minutes (during procedure)
measure: Time of discontinuation of anesthetic to extubation
timeFrame: Up to 30 minutes (during procedure)
Secondary outcomes:
measure: Duration of intensive care unit (ICU) stay
timeFrame: Up to 1 month from procedure
measure: Duration of hospital stay
timeFrame: Up to 1 month from procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Bessie Kachulis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05936125: Short Term Outcomes Of Tricuspid Valve Annuloplasty Using A Flexible Band
Official title: Short Term Outcomes Of Tricuspid Valve Annuloplasty Using A Flexible Band
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Valvular Heart Disease
Tricuspid Valve Regurgitation
Keywords: Tricuspid Valve
Tricuspid Valve Regurgitation
Tricuspid Valve Annuloplasty
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Functional tricuspid regurgitation (FTR) remains a common finding in patients with left-sided valvular heart diseases especially mitral valve regurgitation or stenosis. It is mainly caused by dilatation and flattening of the tricuspid valve (TV) annulus as a result of right ventricular (RV) enlargement and is inevitably affected by the RV function. Multiple studies support the better outcome of using rigid ring annuloplasty over suture repair for treating FTR in concern with the durability and freedom from residual regurgitation. These studies refer the superiority of rigid ring annloplasty to the three-dimensional configuration achieved by such rings which matches the normal tricuspid annulus and, at the same time, to the rigid support of the annulus. On the other hand, other studies support the use of flexible prosthetic bands like Dacron or polytetrafluroethilin (PTFE), especially over suture techniques, due to their easy applicability and availability with good postoperative results. Therefore, suture annyloplasty became nowadays less convenient for FTR repair since both flexible bands and rigid rings appeared to offer good midterm outcomes in recent meta-analysis studies. However, the ideal annuloplasty method for repairing FTR is still debatable between the three-dimensional (3D) rigid rings versus flexible prosthetic bands. In this retrospective comparative study, we share our experience with flexible fashioned bands in FTR.


Eligibility criteria: Inclusion Criteria:

* All patients presented at Assiut University Hospital with tricuspid valve regurgitation

Exclusion Criteria:

* Age less than 18 years old.
* Tricuspid valve stenosis.
* Organic tricuspid valve disease.
* Infective endocarditis on tricuspid valve.

Primary outcomes:
measure: Tricuspid valve regurgitation
timeFrame: 1 year post operative
Secondary outcomes:
measure: Tricuspid Annular Plane Systolic Excursion (TAPSE)
timeFrame: 1 year post operative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Hospital University
Study officials:
References:
Clinical trial NCT05352425: Effect of the MobiusHD® in Renal Hemodialysis Subjects With Uncontrolled Hypertension
Official title: A Study Assessing the Effect of the MobiusHD® Implant in Renal Hemodialysis Subjects Presented With Uncontrolled Hypertension
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Uncontrolled Hypertension
Keywords: Uncontrolled Hypertension
End Stage Renal Disease
MobiusHD
Lead sponsor: Vascular Dynamics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-28
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, multi-center, open-label clinical trial intended to evaluate the safety and benefit of the MobiusHD® system in renal hemodialysis subjects with uncontrolled hypertension.

Detailed description: Renal hemodialysis patients with uncontrolled hypertension will be considered for the study. Subjects who meet initial screening requirements will undergo non-invasive imaging of the carotid anatomy to assess adequacy of the anatomy to allow placement of the MobiusHD® device. Eligible subjects will receive an implant placed in the internal carotid artery.

Following implantation of the device, subjects will be followed for 60 months.

Eligibility criteria: Inclusion Criteria:

1. Age 21 years or above
2. End Stage Renal Disease subjects receiving renal hemodialysis at least 3 months prior to procedure
3. Hypertension that is unresponsive to medical therapy of at least 3 anti-hypertensive medication classes
4. Deemed an acceptable candidate for the implant procedure by the investigator
5. Adequacy of the carotid anatomy for treatment with the MobiusHD implant based on non-invasive carotid duplex and CTA imaging, and invasive carotid angiography

Exclusion Criteria:

1. Known or clinically suspected baroreflex failure or autonomic neuropathy
2. History of intradialytic hypotension within the past 3 months
3. Secondary cause of hypertension except treated obstructive sleep apnea syndrome
4. BMI ≥ 45 kg/m2
5. Presence of atherosclerotic plaque in the intended side for implantation as determined by carotid duplex

Primary outcomes:
measure: Incidence of intradialytic hypotension (IDH)
timeFrame: 6 months
measure: Major adverse neurological and cardiovascular events (MANCE)
timeFrame: 6 months
measure: Change in 44-hour ambulatory blood pressure measurements (ABPM)
timeFrame: 6 months
measure: Change in rate of blood pressure related hospitalizations
timeFrame: 6 months
measure: Change in Quality of Life (QoL), assessed by the London Evaluation of Illness (LEVIL) questionnaire
timeFrame: 6 months
measure: Change in Quality of Life (QoL), assessed by the Kidney Disease Quality of Life (KDQOL-36) questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00448825: Novel Pharmacotherapy for Dual Dependence
Official title: Novel Pharmacotherapy for Dual Dependence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Alcohol Dependence
Cocaine Dependence
Keywords: alcohol dependence
alcoholism
cocaine addiction
cocaine dependence
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2007-03-19
Enrollment: 180
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 study is to evaluate the effects of Topiramate and Cognitive Behavioral Therapy for the treatment of alcohol and cocaine dependence.

Detailed description: Our objective is to understand the basic mechanisms that underpin substance dependence, and to develop efficacious treatments for individuals with comorbid cocaine and alcohol dependence.

Participants in this study will be randomly assigned to receive either 300 mg per day of topiramate or placebo. In addition, participants will receive weekly cognitive behavioral therapy for 12 weeks.Follow-up visits will occur at 2 weeks and 1,2,, and 3 months following completion of treatment.

Eligibility criteria: Inclusion Criteria:

* Subjects will be men and women between the ages of 18 years and older.
* Must meet at least three of the seven DSM IV diagnostic criteria for alcohol and cocaine dependence.
* Express a desire for treatment.
* Literacy in English and ability to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments are required.
* Prospective subjects must report cocaine use of at least once per month and alcohol consumption of ≥21 drinks/week and ≥14 drinks/week for men and women respectively, during the past 30 days
* At least one positive urine drug screen for cocaine at screen or baseline prior to randomization.

Exclusion Criteria:

Please contact site for additional information

Primary outcomes:
measure: The topiramate group will be superior to the placebo group on the following outcome measures:increasing the weekly mean proportion of cocaine-free days, decreasing self-reported drinking, and decreasing craving for cocaine and alcohol.
timeFrame: According to Preston Rules from weeks 6 to 12.
Secondary outcomes:
measure: a. Cocaine free weeks; b. Topiramate, compared with placebo, will be associated with an improvement in psychosocial functioning as exemplified by improved general well-being, social functioning, and quality of life.
timeFrame: According to Preston Rules from weeks 1 to 12
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Center for Addiction Research and Education
state: Virginia
city: Richmond
country: United States
facility: University of Virginia Center for Addiction Research and Education
state: Virginia
Study officials:
affiliation: University of Virginia
name: Bankole Johnson, DSc, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00935025: AZD1305 Single and Multiple Ascending Dose Study in Healthy Japanese and Caucasian Subjects
Official title: A Single-center, Single-blind, Randomized, Placebo-controlled, Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Single and Multiple Ascending Oral Doses of AZD1305 Extended-release Capsules in Healthy Male Japanese and Caucasian Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase I
Japanese healthy volunteer
AZD1305
Japanese and Caucasian
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-07-08
Enrollment: 45
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a phase I, single-blind, randomized, placebo-controlled single and repeated ascending dose study to assess the safety, tolerability and pharmacokinetics with oral doses of AZD1305 extended-release capsules in healthy male Japanese and Caucasian subjects. Three (or four if needed) dose levels will be given to Japanese subjects and one of the doses will also be given to Caucasian subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese and Caucasian male subjects 20 to 45 years of age inclusive
* Body weight between 50 and 85 kg, inclusive, with a Body Mass Index (BMI) ≥19 to ≤ 27 kg/m2

Exclusion Criteria:

* Clinically significant illness, surgical procedure or trauma, within two weeks preceding the pre-entry visit until first administration of IP, as judged by the investigator
* History of clinically significant gastrointestinal, mental, cardiac, renal or hepatic disorder, or other significant disease as judged by the investigator
* Habitual smoker (daily use) of tobacco or daily use of nicotine-containing products

Primary outcomes:
measure: Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight
timeFrame: During the study, from screening period to follow-up, 50 days approximately
Secondary outcomes:
measure: Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma and urine after single and repeated oral doses
timeFrame: From predose until 48 hrs post last dose
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Research Site
state: California
city: Baltimore
country: United States
facility: Research Site
state: Maryland
Study officials:
affiliation: California Clinical Trials
name: Mark Yen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06787625: Development of Organoids From Primary Colorectal Tumors and Synchronous Liver Metastases
Official title: Pilot Feasibility Study for the Development of Organoids From Primary Colorectal Tumors and Synchronous Liver Metastases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colo-rectal Cancer
Keywords: colororectal cancer
organoids
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with colorectal cancer and synchronous liver metastases who will undergo liver resection surgery

Brief summary: Pilot feasibility study for the development of organoids from primary colorectal tumors and synchronous liver metastases, to prepare organoids from primary colorectal tumors and synchronous liver metastases. The organoids will allow us to study the function of genes targeted by the activity of the NF-Y/p53 complex.

Detailed description: Organoids will allow us to study the function of genes that are targets of the NF-Y/p53 complex activity. In these organoids, we will perform overexpression and/or silencing of these genes and assays of proliferation, invasion and motility. We will also perform functional assays in cocultures of the organoids with PBMCs from the same patients. This could allow the discovery of new pathways that could be targeted by targeted therapy and/or immunotherapy. Organoid preparation will be performed from fresh colorectal cancer tissue and liver metastasis following enzymatic digestion. Organoid culture medium and specific organic matrix will be used

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years
* Histological and cytological diagnosis of colorectal cancer neoplasia that has developed a liver metastasis
* Patients who are candidates for surgery for colorectal cancer with liver metastasis
* Signing of the relevant informed consent form.

Exclusion Criteria:

* All exclusion criteria adopted in surgical protocols will be applied to the study

Primary outcomes:
measure: Descriptive analyses
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
affiliation: IRCCS National Cancer Institute
name: Giulia Piaggio, Biologist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05439525: Effect of Mulligan on Sub-acromial Space in Patients With Shoulder Impingement Syndrome
Official title: Effect of Mulligan on Sub-acromial Space in Patients With Shoulder Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Impingement
Keywords: mulligan technique
sub-acromial space
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: mulligan and conventional therapy
Primary purpose: TREATMENT

Brief summary: the aim of this study is to investigate the Effect of mulligan technique on sub-acromial space in patients with shoulder impingement syndrome

Detailed description: Shoulder Impingement Syndrome (SIS) is defined as the mechanical entrapment of the rotator cuff (mainly the supraspinatus tendon) or the sub-acromial bursa in the sub-acromial space between the humeral head and the acromion or coracohumeral ligament .It is typically exacerbate when the arm is elevated or when overhead throwing activities are performed . Mulligan technique is a type of manual therapy with hypoalgesic effects, increases joint ROM, enhances muscle function and treats specific pathologies. Mobilization with movement (MWM) can be defined as the application of a sustained passive accessory force / glide to a joint while the patient actively performs a task that was previously identified as being problem.

Eligibility criteria: Inclusion Criteria:

age of patients from 30- 55 years old . Both Male and female.

Shoulder pain and two out of four specified objective signs and symptoms:

Positive Neer impingement test. Positive Hawkins-Kennedy impingement test. Painful or limitation of active shoulder elevation (flexion, abduction, scaption).

Pain or limitation with the functional movement patterns of hand-behind-back or hand-behind-head.

Exclusion Criteria:

Systemic or neurological disorder. Adhesive capsulitis. Cervical radiculopathy. History of shoulder surgery. Corticosteroid injection within the past month Subjects who had received physical therapy treatment for their shoulder within the past three months.

Primary outcomes:
measure: sub-acromial space
timeFrame: up to two weeks
Secondary outcomes:
measure: shoulder range of movement
timeFrame: up to two weeks
Other outcomes:
measure: pressure pain threshold
timeFrame: up to two weeks
measure: shoulder function
timeFrame: up to two weeks
Locations:
city: Cairo
country: Egypt
facility: Deraya university
Study officials:
References: