louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04133428: Prospective Observational Study of the Sacubitril-Valsartan Treatment Effectiveness.
Official title: Prospective Observational Study of the Sacubitril-Valsartan Treatment Effectiveness.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: Heart failure
Severe systolic disfunction
Sacubitril-Valsartan
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2019-10-21
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 older than 18 years old, diagnosed with heart failure and EF ≤ 40%, that after being treated with optimal medical treatment for at least 3 months, remain in functional class II, III or IV. Being this the actual indication for Sacubitril-Valsartan.

100 consecutive patients will be included, 50 of whom with ischemic etiology of heart failure and 50 with non-ischemic, excluding patients with enolic etiology, any contraindication for the treatment intake and that have already been treated with Sacubitril-Valsartan.

Brief summary: The aim of this prospective study is to demonstrate if there is any difference in the treatment response to Sacubitril-Valsartan depending on the ventricular disfunction ethiology in patients with severe systolic disfunction heart failure.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years old.
* Ejection fraction (EF) ≤ 40%.
* Treated with optimal medical treatment for at least 3 months and remained in functional class II, III or IV.
* Patients with ischemic or non ischemic etiology.

Exclusion Criteria:

* Patients with enolic etiology.
* Patients with any contraindication for taking Sacubitril-Valsartan.
* Patients with EF \>40%.

Primary outcomes:
measure: Difference in the treatment response to Sacubitril-Valsartan depending on the ventricular dysfunction etiology.
timeFrame: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
Secondary outcomes:
measure: Determine the microRNA genetic profile in heart failure.
timeFrame: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
Other outcomes:
measure: Evaluate the connection between the biomarkers levels in heart failure and the cardiac remodeling parameters.
timeFrame: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
measure: Study the levels of auricular natriuretic peptide (ANP), auricular natriuretic peptide type B (BNP), urocortin and type I-C terminal pro-collagen.
timeFrame: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Rocío
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: Gonzalo Baron Esquivias
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01329328: Whole-body Vibration With or Without Localized Radiofrequency and Body Composition in Obese Female
Official title: Effect of Whole-body Vibration With or Without Localized Radiofrequency on Body Composition and Subcutaneous Fat in Obese Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: whole-body vibration
radiofrequency
muscular strength
exercise
body composition
Lead sponsor: Universita di Verona
Sponsor class: OTHER
Collaborators: name: Bios S.r.l.
First posted: 2011-04-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to evaluate the effect of whole-body vibration in the presence or absence of localized radiofrequency on body composition in obese female subjects. Moreover, strength tests will be performed. The study hypothesis is that whole-body vibration induces positive changes in body composition i.e., reduction of fat mass and increase of lean mass with associated increase in performance. The possible additive role of radiofrequency will also be assessed.

Detailed description: * recruitment of female obese subjects
* baseline assessment (body composition with dual energy x-ray absorptiometry (DXA) and strength tests)
* 2-mo whole body vibration training (2 sessions a week, 30 min per session) with or without local delivery of radiofrequency (two randomly selected groups)
* final assessment (body composition with DXA and strength tests)
* data collation and analysis

Eligibility criteria: Inclusion Criteria:

* BMI: \>25
* normal locomotion
* informed consent form signed

Exclusion Criteria:

* acute illness
* endocrine pathologies or diabetes mellitus
* vascular pathology
* pacemaker
* pregnancy

Primary outcomes:
measure: Body Composition
timeFrame: 2 months
Secondary outcomes:
measure: Muscular Strength
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Universita di Verona
name: Carlo Zancanaro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01719328: Vinayasa Yoga and Mood
Official title: The Effects of Vinayasa Yoga on Mood and Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Affect
Stress, Psychological
Keywords: yoga,
exercise
affect
mind/body therapies
stress, psychological
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2012-11-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the immediate and cumulative effects of yoga on stress and mood among young adult college students attending an 8-week program in Vinyasa yoga.

Detailed description: Traditional vigorous aerobic exercises (TAE), such as running and bicycling have been shown to improve mood and relieve stress. Yoga is an ancient physical and mental practice that as a form of exercise may share properties of TAE and in turn offer similar mood and stress effects. However, scientifically rigorous studies examining the psychological effects of yoga and published in peer-reviewed Western journals are rare. The aim of this research was to establish preliminary evidence for the acute effects of vinyasa yoga on mood and stress among young adults.

Eligibility criteria: Inclusion Criteria:

* Adult ages 18 or older
* English-speaking

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital- CORO building
state: Rhode Island
Study officials:
affiliation: Brown Alpert Medical School, The Miriam Hospital
name: Beth C Bock, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00584428: High Dose Chemo With Autologous BMT for Treatment of Metastatic Breast Cancer
Official title: High Dose Chemotherapy With Autologous Bone Marrow Transplantation in the Treatment of Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Keywords: Breast Cancer
Cancer Treatment
Breast Cancer Treatment
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Stephenson Cancer Center
First posted: 2008-01-02
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the response rate and the response duration of high dose chemotherapy with autologous bone marrow transplantation as intensification following induction chemotherapy in metastatic breast cancer and to evaluate prospectively the subdivision of patients with metastatic breast cancer according to prognostic groups.

Detailed description: There are 2 phases to this study: 1) Induction- which consists of the administration of chemotherapeutic drugs- at the end of this phase if the cancer has responded, bone marrow will be collected and frozen untol ready for re-infusion; 2) 2nd phase- involves high-doses of chemotherapy followed by infusion of bone marrow cells

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of breast cancer
* Age 18-70
* Breast cancer at first clinical evidence of metastatic disease
* Must have objectively measurable or evaluable disease or be in complete remission

Exclusion Criteria:

* Previous diagnosis of another invasive carcinaom within 10 years (except skin cancer)
* CNS involvement

Primary outcomes:
measure: Once 10 patients enrolled in the study ar followed for at least 6 months, a preliminary analysis of the data will occur.
timeFrame: Undetermined
Secondary outcomes:
measure: No secondary outcomes
timeFrame: Undetermined
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: George Selby, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03432728: Salivary Antioxidant Capacity Before and After Complete Dental Rehabilitation
Official title: Salivary Antioxidant Capacity of Children With Severe Early Childhood Caries (S-ECC) Before and After Complete Dental Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries in Children
Keywords: Antioxidant Capacity
Lead sponsor: Riyadh Colleges of Dentistry and Pharmacy
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Children who are on long term medications,
* Children with chronic diseases
* Children who have had an infection less than three weeks prior to collection of saliva

Brief summary: Salivary samples were obtained from 20 children in their fifth year of life diagnosed S-ECC and 20 age and sex matched controls. Complete dental rehabilitation under general anesthesia was performed for the 20 children with S-ECC, and follow up salivary samples were obtained one week and three months post operatively. The TAC was measured using a commercially available Oxygen Radical Absorbance Antioxidant Assay measurement kit (Zen-Bio ORAC™, AMS Biotechnology, Abington UK).

Detailed description: Background: The association of total salivary antioxidant capacity (TAC) to severe early childhood caries (S-ECC) has been studied in the past. It is not clear if TAC is an indicator of the inflammatory response to the lesion or a marker of the disease.

Aim: This study aimed to measure the salivary TAC levels in children with early childhood caries before and after dental treatment and compare the results to caries free children.

Methodology: Salivary samples were obtained from 20 children in their fifth year of life diagnosed S-ECC and 20 age and gendersex matched controls. Complete dental rehabilitation under general anesthesia was performed for the 20 children with S-ECC, and follow up salivary samples were obtained one week and three months post operatively. The TAC was measured using a commercially available Oxygen Radical Absorbance Antioxidant Assay measurement kit (Zen-Bio ORAC™, AMS Biotechnology, Abington UK).

Eligibility criteria: Inclusion Criteria:

* Medically fit children
* Age below 71 months
* Test group - to be diagnosed with severe ECC
* Control group - to be caries free

Exclusion Criteria:

Primary outcomes:
measure: Change in TAC after one week
timeFrame: One week
measure: Change in TAC after Three months
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Riyadh Colleges of Dentistry and Pharmacy
Study officials:
affiliation: Riyadh Colleges of Dentistry and Pharmacy
name: Sharat C Pani, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06533228: Helmsley 3.0: Abbreviated MRE
Official title: Comparison of Conventional Clinical and Abbreviated MR Enterography Protocols in Children and Adults With Crohn's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Crohn's Disease
Keywords: Magnetic Resonance Imaging (MRI)
Crohn's Disease
Magnetic Resonance Enterography (MRE)
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 300
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children and adults

Brief summary: The purpose of our study is to compare an abbreviated magnetic resonance imaging (MRI) of the bowel or magnetic resonance enterography (MRE) protocol to a conventional, standard of care MRE in children and adults with Crohn's Disease.

Detailed description: This multi-center study will evaluate the effectiveness of an abbreviated magnetic resonance imaging (MRI) of the bowel or magnetic resonance enterography (MRE) to document the presence and severity of small bowel inflammation, the presence and features of stricturing and penetrating disease in children and adults with Crohn's Disease.

The abbreviated MRI of the bowel or MRE will not involve IV contrast or an injection of glucagon and water will replace the oral contrast used in standard of care MREs. Scan time will be greatly reduced with the abbreviated MRE ( approximately 15 minutes) compared to a standard of care MRE (approximately 60 minutes).

Eligibility criteria: Inclusion Criteria:

* Established Crohn's disease diagnosis in patients 10 and older
* Undergoing clinical magnetic resonance enterography (MRE) examinations for any reason(s) below

  * Staging/ restaging/ follow- up of intestinal inflammation
  * Evaluation of known or suspected luminal narrowing/ stricturing disease
  * Evaluation of known or suspected internal penetrating disease

Exclusion Criteria:

* Undergoing initial imaging for suspected Crohn's disease where the diagnosis of Crohn's disease has yet to be definitively established
* New Crohn's disease diagnosis, undergoing baseline imaging
* Isolated colonic disease
* Known or suspected pregnancy
* Contraindication to magnetic resonance imaging (MRI)
* Ileostomy or prior ileal resection
* Less than 10 years of age
* Unable or unwilling to follow imaging procedures
* Non- English speaking

Primary outcomes:
measure: Compare clinical MRE with research MRE
timeFrame: 3 years
Secondary outcomes:
measure: Patient experiences and preferences between the abbreviated MRE and the standard clinical MRE.
timeFrame: 3 years
measure: Willingness to trade diagnostic performance for patient experience
timeFrame: 3 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: NYU Langone
state: New York
Study officials:
affiliation: CCHMC
name: Jonathan Dillman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04674228: Review of Post-Study Clinical Endoscopy Reports in Follow Up to MAY2016-07-01
Official title: Review of Post-Study Clinical Endoscopy Reports in Follow Up to MAY2016-07-01 Weekly Erlotinib for Familial Adenomatous Polyposis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Familial Adenomatous Polyposis
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2020-12-19
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in MAY2016-07-01 Phase II Trial of Weekly Erlotinib Dosing to Reduce Duodenal Polyp Burden Associated with Familial Adenomatous Polyposis

Brief summary: This study reviews post study clinical endoscopy reports in follow up to patients who participated in MAY2016-07-01 with weekly erlotinib for familial adenomatous polyposis. Reviewing follow up medical records may help researchers examine the extent of rapid progression of familiar adenomatous polyposis disease burden after discontinuation of weekly erlotinib.

Detailed description: PRIMARY OBJECTIVE:

I. To review clinical endoscopy reports, pathology reports, and other medical records related to standard-of-care endoscopic evaluations for all participants in the parent study, MAY2016-07-01, to determine the extent of reports of rapid progression of recurrent polyps after completion intervention and follow up under the parent protocol.

OUTLINE:

Patients who participated in MAY2016-07-01 undergo review of medical records.

Eligibility criteria: Inclusion Criteria:

* MAY2016-07-01 study participants for whom medical records are available and accessible

Exclusion Criteria:

* MAY2016-07-01 study participants who have opted out of medical records reviews or for whom consent for medical record review cannot be confirmed/documented

Primary outcomes:
measure: Number of study participants exhibiting clinically significant progression of duodenal neoplasia after completion of study drug
timeFrame: At completion of study
measure: Number of participants who underwent surgical resection
timeFrame: At completion of study
measure: Number of participants who required endoscopic resection of advanced upper gastrointestinal (GI) neoplasms
timeFrame: At completion of study
Secondary outcomes:
measure: Number of participants with evidence of progression of upper GI disease
timeFrame: At completion of study
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: Mayo Clinic in Rochester
name: Niloy J Samadder
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00869128: A Study of the Efficacy of Prolonged-Release Melatonin Versus Placebo in Diabetic Patients Suffering From Insomnia
Official title: A Randomized Double-Blind, Crossover Study Comparing the Efficacy of Prolonged-Release Melatonin Versus Placebo in a 3 Week Treatment of Diabetic Patients Suffering From Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Insomnia
Keywords: melatonin
insomnia
diabetes
sleep
Lead sponsor: Neurim Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2009-03-25
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Objective - Type 2 uncontrolled diabetic patients often have low endogenous melatonin and suffer from sleep disorders. The effect of a prolonged-release melatonin (PRM) formulation on glucose lipid metabolism and sleep is studied in type 2 diabetes patients with insomnia.

Detailed description: Methods: In a randomized, double-blind, crossover study, the subjects were treated for 3 weeks with 1 tablet per night of 2 mg prolonged-release melatonin or placebo, with one week washout period in between. Sleep was objectively monitored by wrist actigraphy. Fasting glucose, fructosamine, insulin, C-peptide, triglycerides, cholesterol (total, HDL and LDL) and some antioxidants were assessed at baseline and end of each period.

Eligibility criteria: Inclusion Criteria:

* Diabetic patients with proven presence of the disease who complained of insomnia.

Exclusion Criteria:

* Patients with liver or renal problems (serum creatinine above 1.5 mg/dL).

Primary outcomes:
measure: Sleep Efficiency
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Evaluation & Rehabilitation and Palliative Unit, Shoham Geriatric Medical Center, Pardes Hana, Israel
name: Doron Garfinkel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00180128: AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia
Official title: AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia(APL)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Leukemia, Promyelocytic, Acute
Keywords: acute promyelocytic leukemia
risk adapted therapy
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In AIDA 2000 therapy of acute promyelocytic leukemia (APL) is given in a risk-adapted manner. Risk factors are age and white-blood-cell (WBC)-count at diagnosis. Induction therapy is done with ATRA and idarubicin followed by postremission therapy with daunorubicin and mitoxantrone in age adapted dosages. Patients with an high WBC were additionally treated with cytarabine. Finally a two year period of maintenance therapy with 6-mercaptopurine, methotrexate and ATRA is performed.

Detailed description: In AIDA 2000 therapy of acute promyelocytic leukemia (APL) is given in a risk-adapted manner. Risk factors are age and white-blood-cell (WBC)-count at diagnosis. Induction therapy is done with ATRA and idarubicin followed by postremission therapy with daunorubicin and mitoxantrone in age adapted dosages. Patients with an high WBC were additionally treated with cytarabine. Finally a two year period of maintenance therapy with 6-mercaptopurine, methotrexate and ATRA is performed.

Eligibility criteria: Inclusion Criteria:

* acute promyelocytic leukemia confirmed by detection of t(15;17) and/or PML/RARa
* no contraindication for chemotherapy
* written informed consent

Exclusion Criteria:

- severe comorbidities

Primary outcomes:
measure: overall survival
Secondary outcomes:
measure: toxicity of the regimen
measure: evaluation of additional risk factors
measure: effectiveness of MRD as guidance for therapy decisions
measure: relapse free survival
measure: complete remission rate
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Medicine I, University Hospital Carl Gustav Carus
Study officials:
affiliation: Department of Medicine I, University Hospital Carl Gustav Carus Dresden
name: Gerhard Ehninger, MD
role: PRINCIPAL_INVESTIGATOR
References: