louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00887302: Metabolomics of Roux-en-Y Gastric Bypass (RYGB) With Gastrostomy
Official title: Johnson and Johnson Ethicon Metabolomics of RYGB With Gastrostomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type II Diabetes Mellitus
Obesity
Lead sponsor: East Carolina University
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2009-04-23
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese caucasian females between the ages of 18-60 who have had bariatric surgery.

Brief summary: This study is an investigation of the "metabolomics of RYGB with gastrostomy."

Detailed description: The rapid and durable remission of type II diabetes mellitis following the gastric bypass operation challenges the current concepts about the etiology of the disease. The surgery, which excludes food from the stomach, duodenum, and proximal jejunum, is quickly followed by a durable drop in glucose and insulin levels. As a result, 4 out of 5 diabetic, morbidly obese individuals who undergo the operation return to a long-term euglycemia with a prolongation of life and a reduction of health care costs.

The investigators at East Carolina University and those at Johnson and Johnson propose to further complete the profile of the upper gut by extending their observation to three additional human models. The investigators will study patients having the gastric band procedure, the gastric sleeve procedure, and those who have a gastric bypass but have a PEG tube inserted later.

Eligibility criteria: Inclusion Criteria:

* Female
* 18-60 years of age
* BMI of 35-65
* Willing to comply with study requirements and long term follow-up
* Capable of understanding the requirements and consequences of surgery and the study
* Is scheduled to have bariatric surgery performed
* Has a negative pregnancy test

Exclusion Criteria:

* Repeat gastric bypass procedure
* Patients who are unable to hold their insulin coverage for 48 hours prior to research visits
* Patients taking TZDs

Primary outcomes:
measure: Metabolics of RYGB with Gastrostomy - Insulin
timeFrame: 03/25/2009-10/12/2012
measure: Metabolics of RYGB with Gastrostomy - Glucose
timeFrame: 03/25/2009-10/12/2012
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: East Carolina University Brody School of Medicine
state: North Carolina
Study officials:
affiliation: East Carolina University
name: Walter Pories, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06405802: Comparison of Technology-assisted and Face-to-face Assessment in Patients With Low Back Pain
Official title: Face-to-Face and Technology-Used Balance, Mobility and Strength Assessment in Patients With Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: tele-evaluation
Low Back Pain
Face to face evaluation
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
Collaborators: name: Bozyaka Training and Research Hospital
name: Dokuz Eylul University
First posted: 2024-05-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Although the concepts of telemedicine and tele-rehabilitation have been frequently emphasized in recent years, the evaluation part remains inadequate. There is no study investigating remote technology-based balance, mobility and strength assessments in patients with low back pain. Therefore, the aim of the study is; It is the examination of face-to-face and technology-based remote balance, mobility and strength assessment in patients with low back pain.


Eligibility criteria: Inclusion criteria

* Those over the age of 18
* People who can read and write
* Patients who have not undergone surgery
* Those whose body mass index is less than 30 m2/kg
* Volunteering to participate in the study

Exclusion criteria

* Patients who underwent surgery due to disc herniation
* Having any spinal pathology
* Having an uncontrolled neurological and metabolic disease
* Having a spinal deformity such as scoliosis or kyphosis
* Those with serious orthopedic, vascular, neurological or psychiatric problems that affect balance

Primary outcomes:
measure: Oswestry disability index
timeFrame: An evaluation was made once at the beginning of the research.
measure: Timed-up and go test
timeFrame: An evaluation was made once at the beginning of the research.
measure: Single Leg Stance Test
timeFrame: An evaluation was made once at the beginning of the research.
measure: Thirty Second Chair Stand Test
timeFrame: An evaluation was made once at the beginning of the research.
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Kâtip Çelebi University Vocational School of Health Services
Study officials:
affiliation: Izmir Katip Çelebi University
name: Muhammed Zahid Uz, Master
role: STUDY_CHAIR
References:
Clinical trial NCT06061302: Multiple Myeloma Yoga Pilot Study
Official title: A Randomized Pilot Study of Yoga Intervention in Patients With Multiple Myeloma on Active Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
yoga
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 31
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: The purpose of this study is to evaluate the feasibility of implementing a weekly yoga intervention in patients with multiple myeloma on active therapy. This study aims to analyze the impact of yoga intervention on physical symptoms (e.g. pain, fatigue, sleep), psychological symptoms (e.g. anxiety, depression), and overall health-related quality of life (HRQOL) in multiple myeloma patients on active treatment.


Eligibility criteria: Inclusion Criteria:

* Any adult of age 18 and above
* Able to understand basic English
* Able to provide informed consent
* Diagnosis of multiple myeloma on active treatment as determined by investigators
* Good performance status as defined by European Cooperative Oncology Group score 0-1
* Able to utilize computer/laptop and smart phone
* Able and willing to travel to the yoga studio for weekly sessions
* Able to utilized a wearable device, such as Apple Watch or Fitbit (optional)

Exclusion Criteria:

* Poor performance status with European Cooperative Oncology Group score 2-4
* Actively participating in another clinical trial
* Poorly controlled mental health symptoms as determined by treating physician
* Reported fall or syncope in the last 2 months prior to enrollment
* Concurrent diagnosis of amyloidosis or other cancer requiring active treatment

Primary outcomes:
measure: Compliance rate of weekly yoga intervention
timeFrame: 12 weeks
measure: Accrual rate of yoga intervention study
timeFrame: 12 weeks
Secondary outcomes:
measure: Short-term impact of yoga intervention on symptom burden
timeFrame: 12-weeks
measure: Short-term impact of yoga intervention on health-related quality of life (HRQOL)
timeFrame: 12-weeks
measure: Short-term impact of yoga intervention on total daily activity
timeFrame: 12-weeks
measure: Short-term impact of yoga intervention on resting heart rate
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Shaunak Pandya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03154502: Sodium Intake in Ecuadorian Population
Official title: Sodium Urinary Excretion Measurement in Ecuadorian Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dietary Habits
Risk Factor, Cardiovascular
Nutritional Disorder
Keywords: Sodium intake
Urinary sodium excretion
Lead sponsor: Universidad San Francisco de Quito
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 130
Sex: ALL
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Will be enrolled a sample of 178 adults aged 25 to 64 years. The research team, who have faculty appointments in USFQ, supervised the collection of the urine samples. We invited a broad spectrum of employees (which included health care workers, professors, and custodial staff) from both institutions to participate in the study.

Brief summary: This study is aim to determine the sodium intake in Ecuadorian population that is an unknown information at present. For that, 24h urine samples will be collected from 130 subjects working either at tue USFQ or HDLV to measure sodium excretion.


Eligibility criteria: Inclusion Criteria:

* None

Exclusion Criteria:

* unable to provide informed consent
* unable to provide 24-hr urine excretion sample
* those with a known history of heart or kidney failure, stroke, and liver disease
* those using diuretics, multivitamins, NSADs, or prostaglandins during the last two weeks
* pregnant women

Primary outcomes:
measure: Urinary sodium excretion
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidad San Francisco de Quito
name: Enrique Teran, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00473902: Older Adult Training Study With Creatine and CLA
Official title: Creatine Monohydrate and Conjugated Linoleic Acid Improve Strength and Body Composition Following Resistance Exercise in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2007-05-16
Enrollment: 39
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We examined whether creatine monohydrate (CrM) and conjugated linoleic acid (CLA) could enhance strength gains and improve body composition (i.e., increase fat-free mass (FFM); decrease body fat) following resistance exercise training in older adults (\> 65 y). Our study hypothesized that administering CrM and CLA would yield greater strength and body composition benefits than the placebo group over the six months of resistance exercise

Detailed description: Men (N=19) and women (N=20) completed six months of resistance exercise training with Creatine Monohydrate (5g/d) + Conjugated Linoleic Acid (6g/d) or placebo with randomized, double-blind, allocation.Outcomes included; strength and muscular endurance, functional tasks, body composition (DEXA scan), blood tests (lipids, liver function, CK, glucose, systemic inflammation markers (IL-6, C-reactive protein)), urinary markers of compliance (creatine/creatinine), oxidative stress (8-OH-2dG, 8-isoP) and bone resorption (Ν-telopeptides).

Eligibility criteria: Inclusion Criteria:

* Healthy,
* Ambulatory,
* Recreationally active,
* Community dwelling

Exclusion Criteria:

* Evidence of coronary heart disease;
* Congestive heart disease;
* Uncontrolled hypertension;
* Chronic obstructive pulmonary disease;
* Diabetes mellitus;
* Renal failure;
* Major orthopedic disability; and
* Smoking

Primary outcomes:
measure: a. Muscle and bone mass b. Knee extension strength e. Creatine content f. Muscle oxidative capacity g. Aerobic power (oxygen consumption)
timeFrame: six months
Secondary outcomes:
measure: a. Functional capacity b. Strength with weight machines
timeFrame: six months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University Medical Center
state: Ontario
Study officials:
affiliation: McMaster University
name: Mark A Tarnopolsky, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tarnopolsky M, Zimmer A, Paikin J, Safdar A, Aboud A, Pearce E, Roy B, Doherty T. Creatine monohydrate and conjugated linoleic acid improve strength and body composition following resistance exercise in older adults. PLoS One. 2007 Oct 3;2(10):e991. doi: 10.1371/journal.pone.0000991.
Clinical trial NCT00225602: Assertive Community Treatment in Copenhagen
Official title: Quasi-Experimental Trial of the Effect of Assertive Community Treatment Among Those With Severe Mental Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Bipolar Disorder
Keywords: Schizophrenia
Assertive community treatment
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Copenhagen Hospital Corporation
First posted: 2005-09-26
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effect of assertive community treatment in Copenhagen in two regions compared with two regions where this treatment was not implemented. The effect on user satisfaction, use of bed days, social network, global assessment of functioning, substance misuse will be evaluated.

Detailed description: In area where assertive community treatment was implemented 100 patients had filled in a form regarding their social situation. They were interviewed after one year and asked about user satisfaction and followed up in Danish registers. Register information was extracted concerning vital status, cause of death, use of psychiatric services and criminal record. The same procedure was carried out for a comparison group, carefully matched, from other regions in Copenhagen, where assertive community treatment was not implemented.

Eligibility criteria: Inclusion Criteria:

* User of bed days exceeded 40 days last two years; or
* 4+ admissions during last two years; or
* A second diagnosis of substance misuse; or
* Non compliance with medication or outpatient visits in usual settings; or
* Being unable to use other existing services

Exclusion Criteria:

* Forensic patient with a sentence to stay in hospital

Primary outcomes:
measure: Adherence to treatment
Secondary outcomes:
measure: Experience of violation of personal integrity and privacy in relation to treatment
measure: User satisfaction
measure: Quality of Life
measure: Substance misuse
measure: Social network
measure: Affiliation to labor market
measure: Independent living
measure: Crime
measure: Suicidal behaviour
measure: Use of psychiatric services
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Merete Nordentoft, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00432302: Investigation of Mass Balance of the Test Drug and Major Metabolites
Official title: Investigation of Mass Balance and Major Metabolites After Administration of 28 mg Radiolabeled ZK 219477 in Patients With Solid Tumor in an Open-label, Non Randomized Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: Cancer
Tumor
Malignancy
Mass Balance
Chemotherapy
Drug
Cancer Treatment
Intravenous Infusion
Epothilone
Solid Tumor
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-02-07
Enrollment: 7
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: The purpose of this study is to: a) Determine how the body takes up the test drug and distributes it into various body organs and tissues, how it processes the drug and how it ultimately removes it; and b) Examine how well the test drug works against cancer, and whether it is safe and tolerable to take

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Eligibility criteria: Inclusion Criteria:

* Male ≥ 18 years; female ≥ 50 years without childbearing potential (confirmed by either: age ≥ 60; or history of hysterectomy; or hormone analysis in serum: Estradiol ≤ 20 pg/mL and follicle stimulating hormone ≥ 40 IU/L)
* Solid tumor
* Adequate function of major organs
* Failed previous cancer treatment
* Peripheral venous access

Exclusion Criteria:

* Concurrent severe and/or uncontrolled disease
* Brain tumors
* Marked constipation

Primary outcomes:
measure: Blood, urine and fecal samples will be collected over a period of 336 hours (14 days) to measure 14C, ZK 219477 and its major metabolites following the intravenous administration of 14C-ZK 219477.
timeFrame: 14 days
measure: Cmax
timeFrame: 14 days
measure: tmax
timeFrame: 14 days
measure: AUC
timeFrame: 14 days
measure: AUC(0-tlast)
timeFrame: 14 days
measure: AUC(0-24)
timeFrame: 14 days
measure: MRT
timeFrame: 14 days
measure: t1/2
timeFrame: 14 days
measure: λz
timeFrame: 14 days
measure: CL
timeFrame: 14 days
measure: Vss
timeFrame: 14 days
measure: Vz
timeFrame: 14 days
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Approximately 12 weeks to 30 weeks
measure: Overall response
timeFrame: Approximately 10 to 32 weeks
measure: Best overall response
timeFrame: Approximately 10 to 32 weeks
measure: Responders
timeFrame: Approximately 10 to 32 weeks
Other outcomes:
Locations:
city: Liege
country: Belgium
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01127802: Changes of Functional Status, Symptoms Distress and Quality of Life in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
Official title: Changes of Functional Status, Symptoms Distress and Quality of Life in Patients Undergoing CABG Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Bypass Graft Surgery
Keywords: CABG
functional status
symptoms distress
quality of life
the trajectory of functional status
the changes of symptoms distress
the changes of quality of life
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2010-05-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing elective CABG surgery

Brief summary: The purpose of this study is to explore the changes of functional status, symptoms distress and quality of life in patients undergoing coronary artery bypass graft (CABG) surgery.

Detailed description: This is an observational cohort study. The participants will be inpatients undergoing elective CABG surgery at one tertiary medical center. Functional status (including activity of daily living, cognitive and nutritional status), symptom distress, and quality of life will be measured at multiple points: pre-surgery, day 1 to 7 post-surgery, before discharge, and 2-4 weeks after discharge. Structured questionnaire will be used to collect demographic and medical characteristics. The Barthel Index, hand-held dynamometer, 6-minute walking test, Mini-Nutritional Assessment (MNA), Mini-Mental State Examination (MMSE), Confusion Assessment Method (CAM), Symptoms Distress Scale, and Short-Form-36 Health Survey (SF-36) will be used to collect functional data and compared for changes. The trajectory of functional status, symptoms distress, and quality of life will be further analyzed. The findings will add to the literature by raising the awareness on changes of functional status, symptoms distress, and quality of life for patients undergoing elective CABG so targeted and timely intervention could be developed and planned.

Eligibility criteria: Inclusion Criteria:

* receive elective coronary artery bypass surgery
* able to communicate in Chinese and Taiwanese
* walk independently or use walker
* length of stay is over 7 days

Exclusion Criteria:

* unable to walk
* mechanical ventilation
* neural or muscle disease to influence ambulation(ex: Parkinson Disease)
* asthma
* severe psychotic disorder that prevents patient from participating in test

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Chia-Hui Chen, Ph. D.
role: STUDY_CHAIR
References:
Clinical trial NCT01740102: Clinical Value of Remote Ischemic Preconditioning
Official title: Does Remote Ischemic Preconditioning Reduce the Incidence of Postoperative Atrial Fibrillation in Patient Undergoing Coronary Artery Bypass Graft Surgery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Atrial Fibrillation
Keywords: Ischemic preconditioning
Coronary artery bypass
Preoperative care
Postoperative period
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Helse Nord-Trøndelag HF
name: Namsos Hospital
name: Sykehuset Innlandet HF
name: Helse Møre og Romsdal HF
First posted: 2012-12-04
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objectives: Despite utilization of available means for cardioprotection during cardiac surgery, myocardial injury still occurs. Further improvement of cardioprotection is therefore necessary. Remote ischemic preconditioning (RIPC) is an easy and non-invasive method. Laboratory research has shown promising results regarding myocardial survival during open heart surgery, but the clinical value of RIPC is still largely unknown. The investigators hypothesize that RIPC before coronary artery bypass grafting (CABG) reduces the incidence of postoperative atrial fibrillation (POAF).


Eligibility criteria: Inclusion Criteria:

* Elective isolated on-pump CABG surgery
* Informed consent

Exclusion Criteria:

* Patients with a severe pulmonary disease
* Patients with renal failure (GFR\<30 mL/min/1.73 m2)
* Patients with liver failure
* Peripheral vascular disease affecting the upper limbs
* Patients on sulfonylurea derivatives.
* Patients with atrial fibrillation in their case history
* Prior cardiac surgery (Re-operations)

Primary outcomes:
measure: Postoperative atrial fibrillation
timeFrame: Up to 10 days after surgery
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Maximum 14 days
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital Trondheim University Hospital
Study officials:
affiliation: Faculty of Medicine Norwegian University of Science and Technology Trondheim, Norway, and Department of Cardiothoracic Surgery, St. Olavs Hospital, Trondheim, Norway.
name: Alexander Wahba, MD prof
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine Norwegian University of Science and Technology Trondheim, Norway.
name: Lars Erik B Krogstad
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krogstad LE, Slagsvold KH, Wahba A. Remote ischemic preconditioning and incidence of postoperative atrial fibrillation. Scand Cardiovasc J. 2015 Jun;49(3):117-22. doi: 10.3109/14017431.2015.1010565. Epub 2015 Feb 24.