louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02671474: Valve Leaflet Motion in Sutureless Bioprosthetic Aortic Valves
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Heart Valve Disease
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2016-02-02
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Primary purpose: DIAGNOSTIC

Brief summary: A single-center prospective interventional trial. Patients implanted with a sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden from 2012 will be eligible. 4-dimensional volume-rendered computed tomography (CT) of the heart will be performed. The aim of the CT is to assess valve leaflet motion. Results of the CT examination, preoperative clinical characteristics, and postoperative clinical data will be registered. Data will be collected prospectively and retrospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.


Eligibility criteria: Inclusion Criteria:

* Implanted with a sutureless Perceval (Sorin Group) sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden between 2012 and 2016
* Provide written informed consent

Exclusion Criteria:

* Contraindication for CT with intravenous contrast injection

Primary outcomes:
measure: Reduced aortic valve leaflet motion
timeFrame: At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital
Study officials:
References:
citation: Dalen M, Sartipy U, Cederlund K, Franco-Cereceda A, Svensson A, Themudo R, Svenarud P, Bacsovics Brolin E. Hypo-Attenuated Leaflet Thickening and Reduced Leaflet Motion in Sutureless Bioprosthetic Aortic Valves. J Am Heart Assoc. 2017 Aug 21;6(8):e005251. doi: 10.1161/JAHA.116.005251.
Clinical trial NCT00157274: Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome
Official title: Phase II Study of Alemtuzumab in Patients With Advanced Mycosis Fungoides/Sezary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Mycosis Fungoides
Sezary Syndrome
Keywords: Alemtuzumab
Mycosis fungoides
Sezary
Lead sponsor: Latin American Cooperative Onco-Haematology Group - Peru
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators designed a compassionate basis phase II study for refractory/relapsed mycosis fungoides/Sezary syndrome consisting of alemtuzumab (Campath) for primary evaluation of overall response and time to relapse. Other goals to consider are toxicity and time to new therapy.

Detailed description: * 20 relapsed or refractory advanced mycosis fungoides/Sezary syndrome patients are scheduled with gradually escalated doses (3 mg, 10 mg , and 30 mg) on sequential days during the first week, followed by 30 mg three times a week until 12 weeks.
* Patients must have serology negative for human T-lymphotropic virus 1 (HTLV-1) and until three different regimens of chemotherapy.
* Follow up for one year after last cycle of alemtuzumab.

Eligibility criteria: Inclusion Criteria:

* Above 18 years old
* Eastern Cooperative Oncology Group (ECOG) 0-2
* Liver and renal function test less than twice upper label
* No active infection
* Written informed consent
* One to three regimens of previous chemotherapies

Exclusion Criteria:

* Abnormal renal or hepatic function
* Mycosis fungoides/Sezary syndrome in transformation
* HIV +
* HTLV-1 +
* Pregnancy
* Lactation

Primary outcomes:
measure: Overall response
measure: Time to relapse
measure: Event free survival
Secondary outcomes:
measure: Toxicity
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Schering Peruana S.A.
Study officials:
affiliation: LACOGH - PERU
name: Brady E Beltran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lundin J, Hagberg H, Repp R, Cavallin-Stahl E, Freden S, Juliusson G, Rosenblad E, Tjonnfjord G, Wiklund T, Osterborg A. Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sezary syndrome. Blood. 2003 Jun 1;101(11):4267-72. doi: 10.1182/blood-2002-09-2802. Epub 2003 Jan 23.
Clinical trial NCT03870074: CPET Predicts Long-term Survival and Positive Response to CRT
Official title: Cardiopulmonary Exercise Test Predicts Long-term Survival and Positive Response to Cardiac Resynchronization Therapy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: heart failure
cardiac resynchronization therapy
cardiopulmonary exercise test
responders to CRT
non-responders to CRT
survival prognosis after CRT
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study comprised 122 patients qualified for CRT-D and followed-up for five years after CRT implantation. Patients were qualified for CRT-D based on the guidelines of the European Society of Cardiology in 2007 and its update in 2010.

Brief summary: The study tested the usefulness of cardiopulmonary exercise test (CPET) in selection of potential responders to CRT.

Detailed description: Cardiac resynchronization therapy (CRT) is an acknowledged therapy of selected patients with heart failure (HF). One of the unresolved problems is high percentage of non-responders to CRT, reaching 40%. No single parameter, helpful in identifying non-responders prior to CRT implantation, was found.

The study included patients with HF of ischemic or non-ischemic etiology, in NYHA class II-IV, EF≤35% and QRS≥120ms. All the patients had CRT implanted. Clinical evaluation, CPET and NT-proBNP levels measurement were performed before CRT implantation and after 3-6 months. Improvement in HF symptoms of one or more NYHA class correlated with two-years survival. It was used as the criterion of positive response to CRT.

Eligibility criteria: Inclusion Criteria:

* HF in class III or IV according to New York Heart Association (NYHA) in the course of ischemic (ICM) or non-ischemic cardiomyopathy (NICM), QRS complex duration ≥ 120ms, EF ≤35% and dilatation of the left ventricle diastolic diameter \>55mm (LVdD), according to the ESC guidelines in 2007
* HF in NYHA class II, LBBB with QRS complex duration ≥ 150 ms according to the guidelines update in 2010
* optimal pharmacotherapy of HF in the period of three months prior to the study entry.
* the expected survival of the patient \> 1 year.

Exclusion Criteria:

* severe chronic obstructive pulmonary disease (FEV1 \<30%)
* inability to perform a stress test on a treadmill

Primary outcomes:
measure: Death
timeFrame: Follow up within 5 years from CRT
measure: Heart transplantation
timeFrame: Follow up within 5 years from CRT
Secondary outcomes:
measure: Positive response to CRT
timeFrame: Follow up within 1 year from CRT
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Cardiology
name: Tomasz Chwyczko, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00638274: Comparison of Loss of Resistance Techniques
Official title: Comparison of Loss of Resistance Technique With Air Versus Saline to Identify Epidural Space for Combined Spinal Epidural Labor Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain Relief
Keywords: Quality of pain relief with 2 different methods of identifying epidural space
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2008-03-19
Enrollment: 356
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine whether there is a difference in success outcome of the combined spinal epidural labor analgesia between air versus saline when used to identify the epidural space.

Detailed description: When the epidural needle is inserted initially, it is typically connected to a syringe filled with 2-3 ml or air or saline. This is used to help identify the placement of the epidural needle. Both air and saline are commonly used and it is not clear and debatable which is a better method to identify the correct placement of the needle. Some doctors like using air in the syringe because when a drop of clear fluid returned from the smaller spinal needle, it would be clear to indicate the correct space for first dose of medicine since no pre-existing fluid was used. In group Saline, 3 mL of saline will be used. In group Air, 3 mL of air will be used in the syringe during the procedure.

The medicine will be administered in the usual manner the doctor has identified the correct location for administration. The amount of pain during labor will be assessed the patient giving a number from 0 to 10 with 0 being no pain and 10 being the worst pain.

Eligibility criteria: Inclusion Criteria:

* Pregnant females weighing less than or equal to 250 lbs
* Request for neuraxial labor analgesia

Exclusion Criteria:

* ASA physical status greater than II

Primary outcomes:
measure: Success of Spinal Labor Analgesia From Combined Spinal Epidural
timeFrame: 24 hours
Secondary outcomes:
measure: Number of Participants With Failed Epidural Catheters
timeFrame: 24 hours
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: Peter H. Pan, MSEE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01666574: The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake
Official title: The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Intake
Satiety
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: PepsiCo Global R&D
name: Quaker Oats Company
First posted: 2012-08-16
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is to determine if two breakfasts of equivalent calories, an oat based breakfast cereal or a ready-to-eat cereal, provide the same satiety benefits. The study will also determine if the two calorically equivalent oat-based breakfast cereals give different caloric intakes at a lunch meal that participants will eat to their satisfaction.

Detailed description: The Second trial (Period 2): An additional 48 healthy men and women 18 years of age or older will be enrolled to investigate the satiety and food intake at lunch after a breakfast consisting of one of two randomly assigned oat-based cereals and milk breakfast. Visual analogue scales of hunger and satiety will be completed before breakfast and at, 30, 60, 120, 180, and 240 minutes following consumption. Subjects will be asked to eat Lunch until satisfied. The subjects will have the two breakfasts in a balanced and random order and the two meal tests will be separated by at least a week.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older and are healthy.
* Taking no regular medications other than birth control or hormone replacement therapy.
* Are willing to use an effective method of birth control if you are capable of bearing children. Acceptable methods include abstinence, barrier methods, intrauterine devices, and hormonal methods of contraception.

Exclusion Criteria:

* Are a woman who is pregnant or nursing a baby.
* Have gained or lost 8.8 pounds or more in the last 3 months.
* Have diabetes or a fasting blood sugar over 126 mg/dL.
* Have a score of 14 or greater on the restraint scale of the 3-factor eating questionnaire (a questionnaire which will be given to you by the study staff).
* Are allergic to oats, lactose-free milk, Honey Nut Cheerios or oatmeal.

Primary outcomes:
measure: Satiety Impact
timeFrame: Baseline to 2 days
Secondary outcomes:
measure: Impact on food intake at lunch
timeFrame: Baseline to 2 days
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
Clinical trial NCT04439474: Determining the Effect of Vitamin D, Dyslipidemia and Microvascular in Patients With Type 2 Diabetes
Official title: Determining the Effect of Vitamin D, Dyslipidemia and Microvascular in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 187
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study looked at the effect of vitamin D levels on the complications of type 2 diabetes and the fat profile of patients with diabetes.Participants in this study were divided into two groups. One group included participants with vitamin D deficiency and the other group did not.The first group receives 50,000 units of oral vitamin D 3 daily for up to 8 days.


Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes
* Having conscious satisfaction

Exclusion Criteria:

* Patients with a history of gastrointestinal surgery
* Patients with a history of renal failure
* Patients with a history of vitamin D intake and calcium-containing compounds
* Patients with a history of liver disease

Primary outcomes:
measure: Vitamin D serum levels
timeFrame: up to 1 year
measure: Triglyceride
timeFrame: up to 1 year
measure: Blood cholesterol levels
timeFrame: up to 1 year
measure: HDL
timeFrame: up to 1 year
measure: LDL
timeFrame: up to 1 year
measure: Fasting blood glucose
timeFrame: up to 1 year
measure: Neuropathy
timeFrame: up to 1 year
measure: Nephropathy
timeFrame: up to 1 year
measure: Retinopathy
timeFrame: up to 1 year
measure: blood pressure
timeFrame: up to 1 year
measure: HBA1C
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Mohammad Sadegh Bagheri Baghdasht
Study officials:
References:
Clinical trial NCT04534374: Multiple Joint, Structural Barbell Resistance Exercise Improves Information Processing Speed
Official title: Acute Multiple Joint, Structural Barbell Resistance Exercise Improves Information Processing Speed and Decreases Conflict-related Neural Activity in Older Adults: A Crossover, Sham Control, Randomized Control Trial With REP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Aging
Keywords: exercise
resistance training
kinesiology
cognition
ERP
neuroimage
Lead sponsor: National Taiwan Normal University
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 28
Sex: MALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study investigated the effect of acute multiple joint, structural barbell resistance exercise on information processing speed and conflict-related neural activity in older adults via a crossover, sham control, randomized control trial.


Eligibility criteria: Inclusion Criteria:

1. male adults aged 50-65 years old
2. exercise ≥ 150 minutes/week
3. normal or corrected-to-normal vision
4. right-handed

Exclusion Criteria:

1. dementia (MMSE ≥ 24)
2. any medical condition listed on PARQ
3. depression (BDI-II score ≤ 13)
4. any diagnostic cardiovascular, neurological and other chronic diseases

Primary outcomes:
measure: Change of Information processing speed between resistance and stretching exercises
timeFrame: 5-30 minutes before and 10-35 minutes after each intervention.
measure: Change of Inhibitory control between resistance and stretching exercises
timeFrame: 5-30 minutes before and 10-35 minutes after each intervention.
Secondary outcomes:
measure: Change of Conflict-related neural activity between resistance and stretching exercises
timeFrame: 5-30 minutes before and 10-35 minutes after each intervention.
measure: Change of Neural activity related to locus coeruleus phasic response between resistance and stretching exercises
timeFrame: 5-30 minutes before and 10-35 minutes after each intervention.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan Normal University
Study officials:
affiliation: Department of Physical Education, National Taiwan Normal University
name: Tsung-Min Hung, Ph.D.
role: STUDY_CHAIR
References:
citation: Lin TY, Hsieh SS, Chueh TY, Huang CJ, Hung TM. The effects of barbell resistance exercise on information processing speed and conflict-related ERP in older adults: a crossover randomized controlled trial. Sci Rep. 2021 Apr 28;11(1):9137. doi: 10.1038/s41598-021-88634-5.
Clinical trial NCT06486974: Efficacy of Manual Toothbrushes in Removing Tooth Stains
Official title: Efficacy of Manual Toothbrushes in Removing Tooth Stains: A 6-Week Clinical Research Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Tooth Discoloration
Keywords: Lobene Tooth Stain Index
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2024-07-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy of Manual Toothbrushes in Removing Tooth Stains: A 6-Week Clinical Research Study.

Detailed description: The aim of this study is to evaluate the effectiveness of manual toothbrushes in reducing tooth staining after 6 weeks of unsupervised, daily use by participants.

Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent Form;
* Male and female subjects, aged 18-70, inclusive;
* Good general health and good oral health based on the opinion of the study investigator;
* Presence of permanent natural anterior teeth (no veneers/crowns/restorations that may interfere with this study scoring procedures);
* A minimum composite mean of 1.5 ≥ determined by the Lobene Tooth Stain Index;
* Available for the duration of the study;
* Clinical evidence of a tendency to form extrinsic stains on anterior teeth.

Exclusion Criteria:

* Presence of orthodontic appliances/retainers involving scorable teeth;
* Presence of partial removable/fixed dentures and/or restorations involving scorable teeth;
* Tumor(s) of the soft or hard tissues of the oral cavity;
* Obvious signs of periodontal disease rampant caries, or any condition that the dental examiner considers exclusionary from the study;
* Five or more carious lesions requiring immediate care;
* Use of antibiotics, stain-inducing medications, and/or on any prescription that might interfere with the study outcome;
* Concurrent participation in another clinical study;
* Self-reported pregnancy and/or lactating women;
* Have used professional whitening product within one (1) year or had a dental prophylaxis (professional dental cleaning) within thirty (30) days - prior to the start of the study;
* History of allergies to oral care/personal care consumer products or their ingredients;
* History of alcohol and/or drug abuse.

Primary outcomes:
measure: Lobene Tooth Stain Index
timeFrame: Baseline, and 6-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Spa Dental
Study officials:
affiliation: Global Research Consultants
name: Franklin Garcia-Godoy, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05433974: Pre-therapeutic Analysis of the Individual Radiosensitivity of Cancer Patients in Luxembourg (APRI-Lux): Prospective National Interventional Study With Minimal Risk
Official title: Pre-therapeutic Analysis of the Individual Radiosensitivity of Cancer Patients in Luxembourg (APRI-Lux): Prospective National Interventional Study With Minimal Risk
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radiosensitivity
Cancer
Radiation Toxicity
Lead sponsor: Centre Francois Baclesse, Luxembourg
Sponsor class: OTHER
Collaborators: name: BIONEXT
name: Neolys
First posted: 2022-06-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Pre-therapeutic analysis of the individual radiosensitivity of cancer patients in Luxembourg


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old
* Patient with an indication for curative radiotherapy
* Patient having given his signed written informed consent before any specific procedure of the protocol.

Exclusion Criteria:

* Patient with a contraindication to radiotherapy
* Patient with an indication for palliative radiotherapy
* Patient with a history of radiotherapy in the area where the cancer is located
* Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons.

Primary outcomes:
measure: Validation of RadioDtect test on early radiation-induced toxicity
timeFrame: 3 months
Secondary outcomes:
measure: Validation of RadioDtect test on delayed radiation-induced toxicity
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: