louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03308292: Effects of an Exercise Program on Bone Density
Official title: Effects of Exercise in Different Sport Surfaces, Diet and Lifestyle in the Bone Density of Pre and Post Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Density
Body Composition
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 63
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Physical inactivity and low adherence to the Mediterranean diet cause alterations in body composition, which increases the risk factors for cardiovascular and metabolic diseases. In addition, exercise in different surfaces or water could affect the bone density specially in women. Objective: The purpose of the study was to analyze the effect of a short-term aerobic exercise program in different surfaces on the body composition and bone density of women within at work, and to evaluate the quality of the Mediterranean diet and distribution of macronutrients in the studied population. Material \& Methods: Randomized controlled trial. 63 women from a randomized work environment (IG, n=34) and a control group (CG, n=29) participated in a short-term aerobic exercise programmed (12 weeks), for body composition and bone density Dual-energy X-ray absorptiometry (DXA) was used and to evaluate diet, the Mediterranean Diet Quality Questionnaire (KIDMED) and the Food Frequency Questionnaire for macronutrient distribution were used.


Eligibility criteria: Inclusion Criteria:

* Not diagnosed with any disease that contraindicates the practice of physical exercise
* Do not perform physical activity with continuity

Exclusion Criteria:

* Diagnosed with chronic disease including cardiovascular and respiratory diseases that contraindicate the practice of physical exercise
* Being pregnant before or during the intervention (for intervention and control group)

Primary outcomes:
measure: Changes in bone density
timeFrame: 3 months
measure: Changes in body composition
timeFrame: 3 months
Secondary outcomes:
measure: Level of compliance with the exercise program
timeFrame: 3 months
measure: Changes in Dietary pattern variables: macronutrients
timeFrame: 3 months
measure: Changes in Dietary pattern variables: quality of diet
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
citation: Iturriaga T, Barcelo O, Diez-Vega I, Cordero J, Pulgar S, Fernandez-Luna A, Perez-Ruiz M. Effects of a short workplace exercise program on body composition in women: A randomized controlled trial. Health Care Women Int. 2020 Feb;41(2):133-146. doi: 10.1080/07399332.2019.1679813. Epub 2019 Oct 22.
Clinical trial NCT03611192: Multicomponent Exercise on Executive Function and Balance
Official title: Effects of A Multicomponent Exercise on Executive Function and Balance in Pre-frail Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Services for the Aged
Keywords: Multicomponent Exercise
Executive Function
Balance
Pre-frail
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study is to examine the effects of a multicomponent exercise on executive function and balance in pre-frail older adults.


Eligibility criteria: Inclusion Criteria:

* Age≥ 65
* Pre-frail according to the Fried Physical Frailty Phenotype
* Community-dwelling and able to walk independently\>6m

Exclusion Criteria:

* Unstable medical condition (ACSM Health Facility Pre-participation Screening Questionnaire)
* Neurological conditions(eg, Parkinson's disease, stroke, multiple sclerosis)
* MMSE\<24
* Visual or color discrimination impairment

Primary outcomes:
measure: Trail-Making test
timeFrame: Change from baseline at 12 weeks
measure: Stroop test
timeFrame: Change from baseline at 12 weeks
measure: Digit span test
timeFrame: Change from baseline at 12 weeks
measure: Mini-Balance Evaluation Systems Test
timeFrame: Change from baseline at 12 weeks
measure: Time Up & Go test
timeFrame: Change from baseline at 12 weeks
measure: One leg standing test
timeFrame: Change from baseline at 12 weeks
Secondary outcomes:
measure: Montreal Cognitive Assessment
timeFrame: Change from Baseline at 12 weeks
measure: Fried frailty criteria
timeFrame: Change from baseline at 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang-Ming University
Study officials:
References:
Clinical trial NCT01847092: A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria
Official title: An Exploratory Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Design Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZD1722 in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Type 2 Diabetes Mellitus
Keywords: albuminuria
Lead sponsor: Ardelyx
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2013-05-06
Enrollment: 154
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: TREATMENT

Brief summary: The purpose of this study is to determine if the study drug is safe, tolerable and active in reducing albuminuria in patients with Chronic Kidney Disease with Type 2 Diabetes.


Eligibility criteria: Inclusion Criteria:

* Males or females aged 18 to 80 years, inclusive.
* Body mass index between 18 and 45 kg/m2, inclusive.
* Type 2 diabetes mellitus and receiving ≥1 glucose lowering medication for at least 3 months prior to randomization
* Stage 3 CKD
* MSSBP ≥130 mmHg
* Urinary albumin: mean UACR ≥ 200 mg/g

Exclusion Criteria:

* Urinary albumin: UACR \> 3500 mg/g
* History of a renal transplant
* MSSBP \>180 mmHg or a MSDBP of \>120 mmHg on two occasions during screening or run-in periods
* History of inflammatory bowel disease or diarrhea predominant irritable bowel syndrome

Primary outcomes:
measure: Changes in Urine Albumin to Creatinine Ratio (UACR)
timeFrame: Week 12
Secondary outcomes:
measure: Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: Creekside Endocrine Associates PC
state: Colorado
Study officials:
References:
Clinical trial NCT01996592: Persistent Pain After CS Delivery
Official title: Novel Approach Using Pre-surgery Psychosocial State and Pain Trajectory Methods to Identify Patient Characteristics and Predict Patients at Risk for Persistent Pain After Cesarean Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Persistent Pain After Delivery
Keywords: chronic pain
cesarean section pain
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 575
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: those subjects who are scheduled to have an elective cesarean section (CS) and able to complete a preoperative psychosocial/depressive questionnaire and who agree to be contacted on a daily basis for 60 days postoperatively

Brief summary: Many factors influence the development of persistent pain after CS (chronic pain) as well as post-partum depression. We are attempting to use trajectory pain methods in an attempt to identify those at risk for the development of persistent pain post delivery using a daily method of contact for the determination of pain scores. Assessments are also done evaluating satisfaction of pain management and maternal/infant bonding opportunities. Physical activity is monitored by subject's wearing a Fitbit with correlation being done with pain scores obtained over 60 days postop with eligible subjects..

Detailed description: Subjects are contacted on a daily basis after having a cesarean delivery to determine current pain, current pain unpleasantness, worst pain, worst pain unpleasantness, average pain, and average pain unpleaseantness. Preoperatively subjects complete a psycho-social/depressive screening questionnaire. Pain treatments/satisfaction assessments are captured for the first 24 hours. Mother/baby outcomes are also captured. Physical activity and pain scores are also correlated with the subject's wearing of a Fitbit physical activity bracelet with eligible subjects for 60 days post-delivery.

Eligibility criteria: Inclusion Criteria:

* \>/= 18 years of age English speaking

Exclusion Criteria:

non-English speaking

Primary outcomes:
measure: Persistent Pain-PERCEIVED STRESS Scores Stratified by the Rate of Recovery
timeFrame: 60 days
measure: Persistent Pain-EMOTIONAL DISTRESS
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Jessica Booth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00253292: Psychometric Study of Outcomes Instruments
Official title: Psychometric Study of Outcomes Instruments
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Burns
Trauma
Keywords: Burns
Trauma
Outcomes
Quality of Life
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Shriners Hospitals for Children
First posted: 2005-11-15
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the MGH burn unit for a burn injury between the ages of 19-30 years.

Brief summary: The purpose of this study is to develop a standardized, practical self-administered questionnaire to monitor young adult burn patients and to evaluate the effectiveness of burn management treatments with regard to improved function, physical appearance and other relevant outcomes.

Detailed description: Identifying young adult burned patients at risk for poor outcomes remains an underpublished field of study. The first step to identifying these patients is to review their responses to this burn specific young adult measure, that attempts to quantify aspects of quality of life. We are validating this questionnaire by now collecting information from non burned community based subjects and by having burned patients complete the questionnaire at 4 timepoints. Once we have recruited sufficient subjects we will finalize our testing of this questionnaire and publish the validity and reliability of the instrument. Our questionnaires will help us answer the question of how burn people differ from non burned person's reported quality of life. This will complete our array of burn specific outcomes questionnaires from infancy through young adulthood.

Eligibility criteria: Inclusion Criteria:

* All burn injured young adults with or without grafting
* All burned on or after their 17th birthday
* Between the ages of 19-30
* English speaking
* Present for inpatient or outpatient treatment

Exclusion Criteria:

Non-burned skin conditions

* Non-English speaking
* Patients less than 19 years of age
* Patients over 30 years of age

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Shriners Hospital for Children
state: California
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
city: Boston
country: United States
facility: Mass General Hospital
state: Massachusetts
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Chapel Hill
country: United States
facility: Jaycee Burn Center,UNC Healthcare
state: North Carolina
city: Galveston
country: United States
facility: Shriners Hospitals for Children-Galveston
state: Texas
Study officials:
affiliation: MGH, Shriners Burn Hospital - Boston
name: Ronald G. Tompkins, MD, ScD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00414492: Pattern of Cell Death Following Neoadjuvant Therapy for Metastatic Colon Cancer
Official title: Pattern of Cell Death Following Neoadjuvant Therapy for Metastatic Colon Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Keywords: metastatic colorectal cancer
liver metastasis
tumor margins
neoadjuvant therapy
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2006-12-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with colon cancer metastases to the liver

Brief summary: Systemic chemotherapy for metastatic colon cancer is often used in the neoadjuvant setting for patients undergoing liver resection. This treatment is given either to keep the tumor at bay or reduce its size before the time of resection. While many metastatic tumors might appear to respond well and even radiographically disappear following neoadjuvant therapy, it is unclear whether grossly or radiographically negative areas of previous disease are microscopically free of tumor cells. As such, when possible, resection boarders typically follow 1 cm margins from the tumor size prior to neoadjuvant therapy. These margins might be necessary to encompass all histologically present disease or they might be unnecessarily large, serving only to increase the mortality and morbidity of the operation. This study begins to address this question by a histological examination of the pattern of cell death in areas of metastases removed after neoadjuvant therapy. Furthermore, clinical cases in which neoadjuvant therapy allowed for resection of previously unresectable cancer will be examined to determine whether there is an increased rate of recurrence despite "negative" resection boundaries in these cases.


Eligibility criteria: Inclusion Criteria:

* Patients must be ≥ 18 years old.
* Patients must have colon cancer metastases to the liver.
* Patients must be candidates and be scheduled for liver resection.
* Patients must have received and have had a response to neoadjuvant therapy prior to liver resection.
* Patients must have signed Institutional Review Board (IRB) approved written consent form prior to registering in the study.

Exclusion Criteria:

* Patients who are \< 18 years old.
* Patients who do not have colon cancer metastases to the liver.
* Patients who are not surgical candidates.
* Patients who do not schedule or who cancel a liver resection.
* Patients who have not received neoadjuvant therapy.
* Patients who have received neoadjuvant therapy but who have had no response or who have had tumor progression.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Michael A Choti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05162092: Effects of Vestibular Stimulation on Motor Function and Balance in Children With Hypotonic Cerebral Palsy
Official title: Effects of Vestibular Stimulation on Motor Function and Balance in Children With Hypotonic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypotonic Cerebral Palsy
Keywords: vestibular stimulation
motor function
balance
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 82
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: study participants will be randomized in two groups,conventional physiotherapy group and intervention group
Primary purpose: TREATMENT

Brief summary: my study base on 2groups with total sample size 68 patients .group A conventional physiotherapy group in which the duration of session is 30 mints with 5 mints rest .include soft tissue elogation of tight muscles,lowerlimb resistance exercise,movement transitions balance board standing walking and stair climbing.for group b (conventional physiotherapy and vestibular stimulation exercises)30 mints with 10 mints rest.same physiotherpy exercise re given with vestibular stimulation exercises include swinging in standing in all diection,trampoline jump,rocking movement in rocking chair gaze stabilization exercises and visual pursuit exercises

Detailed description: my study base on 2groups with total sample size 68 patients .group A conventional physiotherapy group in which the duration of session is 30 mints with 5 mints rest .include soft tissue elogation of tight muscles,lowerlimb resistance exercise,movement transitions balance board standing walking and stair climbing.for group b (conventional physiotherapy and vestibular stimulation exercises)30 mints with 10 mints rest.same physiotherpy exercise re given with vestibular stimulation exercises include swinging in standing in all diection,trampoline jump,rocking movement in rocking chair gaze stabilization exercises and visual pursuit exercises under supervisio. and use 2 scales,pediatric balance scale and gross motor scale re used for taking data .

Eligibility criteria: Inclusion Criteria:

* age range from 5-10 years.
* both male/female
* have good head control
* hypotonic cerebral palsy
* able to maintained ring sitting position

Exclusion Criteria:

* children will not respond to visual and auditory stimuli due to blindness or deafness or sever mental retardation
* children with un controlled convulsion or vp shunt
* children with severe medical problems children with orthopedic condition

Primary outcomes:
measure: Gross motor
timeFrame: 5 weeks
measure: Balance:
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Mahwash Zulfiqar
state: Punjab
Study officials:
affiliation: The University of Lahore
name: bilal umer
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Lahore
name: anam naz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02126592: The Secretion of Incretin Hormones in Patients With Polycystic Ovary Syndrome
Official title: The Secretion of Incretin Hormones in Patients With Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polycystic Ovary Syndrome
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Jiao Tong University School of Medicine
First posted: 2014-04-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Polycystic Ovary Syndrome(PCOS)

Brief summary: Polycystic ovary syndrome (PCOS) is an endocrine disease in reproductive women. It is characterized by anovulation and hyperandrogenism. Most patients with PCOS have metabolic abnormalities such as dyslipidemia, insulin resistance and glucose abnormalities. Almost 60-80﹪PCOS patients are obesity which exacerbates IR and hyperandrogenism. Obese PCOS patients tend to be overeating suggests that impaired appetite regulation might be contribute to the pathophysiology of PCOS. Our study is trying to observe difference of incretin between PCOS and normal control to figure out whether change of incretin is involved in the pathophysiology of PCOS.


Eligibility criteria: Inclusion Criteria:

* women at reproductive age
* women with PCOS and women without PCOS

Exclusion Criteria:

* young women who had their menarche less than 3 years
* women older than 45 years old, Amenorrhea of menopause, hyperglycemia, hyperthyroidism, hypothyroidism, heart failure, lung failure, renal failure, anemia, dystrophy, gonitis

Primary outcomes:
measure: Change in incretin hormones secretion in PCOS patients.
timeFrame: up to 14 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
References:
Clinical trial NCT04215692: Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients
Official title: Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Fluid Overload Pulmonary Edema
Fluid Overload
Pneumonia, Ventilator-Associated
Fluid Overload Without Edema
Keywords: pediatric intensive care
lenght of stay
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
Collaborators: name: Centenario Hospital Miguel Hidalgo
First posted: 2020-01-02
Enrollment: 68
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomized clinical trial to evaluate the effect of using pulmonary ultrasound to guide fluid therapy on distinct variables.

Detailed description: In this randomized clinical trial, the investigators will evaluate the effect of guiding fluid therapy by pulmonary ultrasound on the following variables:

Length of stay in the pediatric ICU Duration of mechanical ventilation Oxygenation index PaO2/FiO2

Eligibility criteria: Inclusion Criteria:

* All pediatric inpatient intensive care unit admissions
* Signed Informed Consent Form

Exclusion Criteria:

* Cyanotic congenital heart disease
* Not requiring mechanical ventilation

Primary outcomes:
measure: Length of stay
timeFrame: through study completion, an average of 14 days
Secondary outcomes:
measure: Oxygenation Index
timeFrame: Daily through study completion, an average of 14 days
measure: PaO2/FIO2
timeFrame: Daily through study completion, an average of 14 days
measure: Duration of mechanical ventilation
timeFrame: through study completion, an average of 14 days
Other outcomes:
Locations:
city: Aguascalientes
country: Mexico
facility: Centenario Hospital Miguel Hidalgo
Study officials:
References: