louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00333970: Predictors of Response to Cognitive Remediation in Schizophrenia
Official title: Predictors of Response to Cognitive Remediation in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: cognition
neuropsychology
Rehabilitation
treatment efficacy
cognitive remediation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-06-06
Enrollment: 103
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 determine which variables predict improvement on a cognitive training task battery, used for patients with schizophrenia, and to determine the proportion of patients whose performance returns to normal following cognitive training

Detailed description: It has been suggested that level of cognitive function is a "rate-limiter" for the efficacy of other psychosocial treatments in schizophrenia. Cognitive remediation, which entails training and practice of successively more difficult cognitive exercises, has shown efficacy in improving cognitive function. However, the rate of improvement has not been uniform among patients receiving this intervention. Given the time- and cost-intensiveness of cognitive remediation, it is important to examine variables that will predict response to this treatment, as well as to examine the clinical significance of any improvement.

The current proposal has two aims: 1) to determine which neuropsychological, demographic, and illness variables predict response to cognitive remediation training; and 2) to determine the proportion of patients whose performance returns to normal following cognitive remediation training. For the first part of the proposed study, 50 outpatients diagnosed with schizophrenia spectrum disorders will be invited to participate in an 8-week trial of cognitive remediation training. Detailed neuropsychological, demographic, symptom and illness course variables will be collected prior to training, at the conclusion of training, and 4 months from study intake. In order to answer the second question, additional data on the computerized task performance for healthy controls will be collected, and compared to patient data, in order to determine what constitutes normal-range performance

Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia spectrum disorder
* English speakers
* Clinically stable
* No substance abuse in past 30 days

Exclusion Criteria:

* Traumatic brain injury
* Neurological disease
* Diagnosis of mental retardation

Primary outcomes:
measure: Cognitive Performance
timeFrame: baseline and 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Health Care System (West Haven)
state: Connecticut
Study officials:
affiliation: VA Connecticut Health Care System (West Haven)
name: Joanna Fiszdon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01310270: The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation
Official title: The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-03-08
Enrollment: 180
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis being tested is that in patients with stable claudication and documented PAD, omega-3 supplementation for 1 month will lead to improvement in endothelial function as measured by flow-mediated, brachial artery vasodilation (FMD), as well as improvement in the vascular inflammatory profile as measured by a panel of established circulating inflammatory biomarkers.


Eligibility criteria: Inclusion Criteria:

* intermittent claudication
* resting or exercise Ankle-Brachial Index (ABI) \<0.9
* age 50 and more

Exclusion Criteria:

* critical limb ischemia
* hypersensitivity/allergies to fish or seafood
* already on omega-3 fatty acids or equivalent
* significant renal, hepatic, and inflammatory disease
* concurrent severe infections
* acute illness (MI, stroke, major surgery within 30 days)
* receiving immunosuppressive medications or steroids

Primary outcomes:
measure: Endothelial Function
timeFrame: 1 month
Secondary outcomes:
measure: Inflammatory bio-markers
timeFrame: 1 month
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Warren Gasper, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grenon SM, Owens CD, Nosova EV, Hughes-Fulford M, Alley HF, Chong K, Perez S, Yen PK, Boscardin J, Hellmann J, Spite M, Conte MS. Short-Term, High-Dose Fish Oil Supplementation Increases the Production of Omega-3 Fatty Acid-Derived Mediators in Patients With Peripheral Artery Disease (the OMEGA-PAD I Trial). J Am Heart Assoc. 2015 Aug 21;4(8):e002034. doi: 10.1161/JAHA.115.002034.
citation: Chong KC, Owens CD, Park M, Alley HF, Boscardin WJ, Conte MS, Gasper WJ, Grenon SM. Relationship between kidney disease and endothelial function in peripheral artery disease. J Vasc Surg. 2014 Dec;60(6):1605-11. doi: 10.1016/j.jvs.2014.08.105. Epub 2014 Oct 16.
citation: Alley H, Owens CD, Gasper WJ, Grenon SM. Ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery in clinical research. J Vis Exp. 2014 Oct 22;(92):e52070. doi: 10.3791/52070.
citation: Grenon SM, Owens CD, Alley H, Chong K, Yen PK, Harris W, Hughes-Fulford M, Conte MS. n-3 Polyunsaturated fatty acids supplementation in peripheral artery disease: the OMEGA-PAD trial. Vasc Med. 2013 Oct;18(5):263-74. doi: 10.1177/1358863X13503695. Epub 2013 Sep 19.
Clinical trial NCT01544270: The Effects of Dietary Factors on Physiological Subjective Stress Responses
Official title: The Effects of Dietary Factors on Physiological Subjective Stress Responses in Cronically Stressed Subjects: a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stress
Keywords: milk protein
probiotics
stress
cortisol
heart beat
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: SalWe Ltd.
First posted: 2012-03-05
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims to investigate the role of dietary factors in chronically stressed subjects. Previous studies have shown that milk proteins, B vitamins and probiotics may influence on subjective well-being in stressed subjects.


Eligibility criteria: Inclusion Criteria:

* STAI points 40-65
* BMI 18-30 kg/m2
* healthy

Exclusion Criteria:

* Gastrointestinal disease, diabetes or any other significant major medical morbidity
* milk allergy
* smoking
* excess use of alcohol
* pregnancy and breast feeding
* waist circumference males \>102 cm, females \>88 cm
* no medication or dietary supplements influencing measured responses

Primary outcomes:
measure: Subjective well-being
timeFrame: baseline and 4 weeks
Secondary outcomes:
measure: Physiological measurements
timeFrame: baseline and 4 weeks
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: University of Helsinki, Institute of Biomedicine
Study officials:
References:
citation: Jaatinen N, Korpela R, Poussa T, Turpeinen A, Mustonen S, Merilahti J, Peuhkuri K. Effects of daily intake of yoghurt enriched with bioactive components on chronic stress responses: a double-blinded randomized controlled trial. Int J Food Sci Nutr. 2014 Jun;65(4):507-14. doi: 10.3109/09637486.2014.880669. Epub 2014 Feb 4.
Clinical trial NCT01909570: eSET Plus Single Embryo Cryotransfer vs Double Embryo Transfer
Official title: Randomized Clinical Trial Comparing Elective Single Embryo Transfer Plus Single Embryo Cryotransfer vs Double Embryo Transfer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Pregnancy, Multiple
Lead sponsor: University Hospital Virgen de las Nieves
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2013-07-26
Enrollment: 194
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether a policy of elective single embryo transfer (eSET) plus single embryo cryotransfer is as effective as a double embryo transfer in terms of clinical pregnancy rate

Detailed description: The objective is to evaluate the In Vitro Fertilization/Intracytoplasmic Sperm Inyection (IVF/ICSI) results in terms of clinical pregnancy and multiple pregnancy rates, comparing elective single embryo transfer plus cryotransfer of one embryo if pregnancy is not achieved, with double embryo transfer.

This is a prospective randomized study, including couples arriving to the Reproductive Unit of the Hospital Universitario Virgen de las Nieves. All these patients had good reproductive prognosis and had been asigned randomly to one of the following groups: Group 1: elective single embryo transfer. In the case pregnancy is not achieved a cryotransfer of one embryo will be carried out. Group 2: elective double embryo transfer.

Eligibility criteria: Inclusion Criteria:

* women less tan 38 years
* women Body Mass Index (BMI) between 19-39 kg/m2
* Follicle-Stimulating Hormone (FSH) \<15 mUI/mL on cycle third day
* First IVF/ICSI cycle or second after a positive pregnancy test in the first one

Exclusion Criteria:

* More tan five years of infertility
* Previous uterus surgery
* Uterus malformations
* More tan one miscarriage

Primary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: Seven weeks after embryo transfer
Secondary outcomes:
measure: Multiple Pregnancy Rate
timeFrame: Seven weeks after embryo transfer
Other outcomes:
measure: Live Birth Delivery Rate
timeFrame: 38 weeks after embryo transfer
Locations:
city: Granada
country: Spain
facility: Unidad de gestión clínica de ginecología y obstetricia. Instituto Biosanitario de Granada.Hospital Universitario Virgen de las Nieves
Study officials:
affiliation: Investigator and laboratory specialist
name: Ana Clavero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lopez-Regalado ML, Clavero A, Gonzalvo MC, Serrano M, Martinez L, Mozas J, Rodriguez-Serrano F, Fontes J, Castilla JA. Randomised clinical trial comparing elective single-embryo transfer followed by single-embryo cryotransfer versus double embryo transfer. Eur J Obstet Gynecol Reprod Biol. 2014 Jul;178:192-8. doi: 10.1016/j.ejogrb.2014.04.009. Epub 2014 Apr 19.
Clinical trial NCT01722370: Ambulatory Oxygen Effects on Muscles in COPD
Official title: Can Muscle Dysfunction in COPD be Altered by Oxygenation in Patients With Intermittent Hypoxia on Exertion?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: Heart of England NHS Trust
First posted: 2012-11-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Patients with chronic obstructive pulmonary disease (COPD) may develop low oxygen levels, because of damage to their lungs. Long term oxygen therapy (LTOT) is given for at least 15 hours per day, and has established indications and benefits in COPD. However, the indications for and benefits from ambulatory oxygen supplementation (oxygen just when walking or exercising) are less well understood, in part due to heterogeneity of previous study designs, and lack of long term follow up. This is a pilot study of supplementary ambulatory oxygen in COPD, which allows us to ascertain mechanisms of disease by measuring their degree of systemic inflammation pre and post oxygen supplementation, and measuring changes in gene expression in muscles by means of microarray profiling. Secondly, our study will utilise follow up of clinical parameters including home activity monitoring to ascertain medium/long term benefits of oxygen supplementation in a real life setting. Our hypothesis is that exertional hypoxia results in muscle dysfunction and this could be prevented by oxygenation.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of COPD
* desaturation on exertion

Exclusion Criteria:

* using LTOT
* immobile for other reason than COPD

Primary outcomes:
measure: Gene expression pattern change between interventions in skeletal muscle biopsy
timeFrame: 12 weeks
Secondary outcomes:
measure: Six minute walk test distance
timeFrame: 12 weeks
measure: Home activity level as measured by Actigraph
timeFrame: 6 and 12 weeks
Other outcomes:
measure: Blood gases
timeFrame: 12 weeks
measure: Quality of life
timeFrame: 6 and 12 weeks
measure: Anxiety and depression score
timeFrame: 12 weeks
measure: Arterial stiffness
timeFrame: 12 weeks
Locations:
city: Birmingham
country: United Kingdom
facility: Heart of England NHS Foundation Trust
state: West Midlands
Study officials:
affiliation: University of Birmingham
name: Alice M Turner
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06155370: Construction of Gynecological Tumor Organoids
Official title: Construction of Gynecological Tumor Organoids
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gynecologic Cancer
Organoid
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Those diagnosed with gynecological oncology, including cervical cancer, endometrial cancer, ovarian cancer, vulva cancer, vaginal cancer, and gestational trophoblastic tumor.

Brief summary: This study focuses on the construction of a biological sample library for organoids and tumor tissues in gynecological tumors.

Detailed description: Explore the construction and maintenance of a large-scale queue of gynecological tumor organoids. Beijing Daxiang Technology Co., Ltd. provides corresponding technical support and chip design. Gynecological oncology center provides tumor samples, clinical information, and pathological support, and biological sample library provides technical support, storage space, and quality management.

Eligibility criteria: Inclusion Criteria:

1. Age of 18 or older, an informed consent form is provided;
2. The preoperative tumor burden assessment and intraoperative researcher team believe that sampling is feasible;
3. Having relevant requirements for sample library storage;
4. Surgical treatment at Peking Union Medical College Hospital.

Exclusion Criteria:

1. Unable to meet all inclusion criteria;
2. The research team considers any situations or considerations that may hinder normal pathological assessment.

Primary outcomes:
measure: Construction of BioBank
timeFrame: one year
Secondary outcomes:
measure: Drug sensitivity detection based on organoids banks
timeFrame: one year
measure: Exploring the molecular mechanism based on organoids banks
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01662570: Beverage Choice and Lifestyle Modification in Overweight Youth
Official title: Beverage Choice and Lifestyle Modification in Overweight Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Pediatric Obesity
Child Overweight
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-08-10
Enrollment: 65
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The rise in childhood overweightness and concomitant increase in chronic disease risk warrants exploration into the effectiveness of interventions targeting the eating and activity habits of overweight youth. This research study developed and tested a "Beverage Choice and Lifestyle Modification" (BCLM) intervention for 4 to 8 year old children who are at-risk for being overweight or are overweight and who consume large amounts of sugar sweetened beverages and juice. The overall study objectives were to test the acceptability and effectiveness of the BCLM intervention for improving the weight status, energy (kcal) intake, beverage selections and beverage preferences of children in targeted age and BMI group. The investigators hypothesized that those children randomized to the BCLM group will show greater improvements in weight and Body Mass Index (BMI) status, beverage choices,and energy intake than those assigned to our Nutrition Education (NE) group.


Eligibility criteria: Inclusion Criteria:

* Ages 4-8 years old
* BMI≥85th percentile (based on age and sex)
* consumes large (≥16 oz.day) sugar sweetened beverages

Exclusion Criteria:

* Child has a serious medical condition
* Signs of elevated psychopathology are present, as assessed by the Child Behavior Checklist (CBCL)
* Parent demonstrates elevated psychiatric problems or eating disorders
* Failure of parent or child to meet BMI criteria

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: Baseline and Month 6
measure: Body Mass Index z-score (BMI-z)
timeFrame: Baseline and month 6
measure: Body Mass Index Percentile (BMI%)
timeFrame: Baseline and Month 6
measure: Child percent overweight
timeFrame: Baseline and Month 6
measure: Waist Circumference
timeFrame: Baseline to Month 6
measure: Energy (kcal) intake
timeFrame: Baseline to Month 6
measure: Sugar-sweetened beverage intake
timeFrame: Baseline to Month 6
measure: Treatment acceptance and satisfaction
timeFrame: Month 6
Secondary outcomes:
measure: Child preferences and motivation for sugar-sweetened beverages
timeFrame: Baseline and Month 6
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Center for Weight and Eating Disorders
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Myles S Faith, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01589770: Inflammation and the Heart
Official title: Inflammation and the Heart
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
inflammation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Arthritis Foundation
First posted: 2012-05-02
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants underwent cardiac MRI(cMRI) using a 1.5 tesla Siemens Magnetom Avanto scanner to compare left ventricular structure and Left atrium size.
Primary purpose: OTHER

Brief summary: Studies have shown that people with rheumatoid arthritis (RA) have a higher rate of heart disease than people that do not have RA. we believe this is caused by the inflammation produced by RA.

Detailed description: Aim 1: We want to study people with RA to see if we can detect very early changes in their heart muscle and compare these results to people who do not have RA.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age \>= 18
* RA only: meet American College of Rheumatology(ACR)criteria for Diagnosis of RA
* Controls only: no evidence of RA or other inflammatory disease

Exclusion Criteria:

* Previous or current heart failure or ischemic cardiovascular disease (eg stroke, myocardial infarction, angina, CABG, stent).
* Atrial fibrillation.
* Known structural or functional cardiac abnormality, including pulmonary htn.
* Glomerular filtration rate \< 60 ml/min.
* Pregnancy or breastfeeding.
* Unable to perform MRI (claustrophobia, unable to fit in magnet,pacemaker,defibrillator or non-MR safe implant).
* Hypersensitivity to gadolinium.

Primary outcomes:
measure: Left Ventricular Mass Indexed to BSA, g/m^2
timeFrame: one scan, cross sectional comparison
Secondary outcomes:
measure: Left Atrium Size, mm
timeFrame: one scan, cross sectional comparison
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Charles Michael Stein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bradham W, Ormseth MJ, Elumogo C, Palanisamy S, Liu CY, Lawson MA, Soslow JH, Kawel-Boehm N, Bluemke DA, Stein CM. Absence of Fibrosis and Inflammation by Cardiac Magnetic Resonance Imaging in Rheumatoid Arthritis Patients with Low to Moderate Disease Activity. J Rheumatol. 2018 Aug;45(8):1078-1084. doi: 10.3899/jrheum.170770. Epub 2018 Apr 15.