louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01061359: Application Of Epirubicin Within A Neo-/Adjuvant Chemotherapy In Patients With Primary Breast Cancer
Official title: Application Of Epirubicin Within A Neo-/Adjuvant Chemotherapy In Patients With Primary Breast Cancer ((ANWENDUNGSBEOBACHTUNG,MOI 99056 -Neo-/Adjuvante Chemotherapie Des Primären Mammakarzinoms Der Frau Mit Farmorubicin®))
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasm
Keywords: Breast Cancer
Neoadjuvant Treatment
Chemotherapy
Adjuvant
Epirubicin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-02-03
Enrollment: 1981
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients with primary breast cancer

Brief summary: Evaluation of efficacy of treatment with epirubicin (5 years follow-up). Evaluation of frequency of dose reduction. Evaluation of frequency of neoadjuvant treatment with E(120mg) / C(600mg). Evaluation of unexpected and serious adverse events.

(E=Epirubicin; C =Cyclophosphamide)

Detailed description: Postmarketing surveillance study. Non-Probability Sample

Eligibility criteria: Inclusion Criteria:

* Pre- and postmenopausal female patients with histologically confirmed primary breast cancer

Exclusion Criteria:

* Metastatic breast cancer, locally advanced or recurrent breast cancer, previous cancer history

Primary outcomes:
measure: Percentage of Participants With Disease Free Survival (DFS)
timeFrame: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y
Secondary outcomes:
measure: Time to Progression (TTP)
timeFrame: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y
measure: Time to Recurrence (DFI)
timeFrame: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01322659: Weaning Using Noninvasive Positive Pressure Ventilation by Means of Helmet in Patients With Acute Respiratory Failure
Official title: Weaning Using Noninvasive Positive Pressure Ventilation by Means of Helmet in Patients With Acute Respiratory Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inadequate or Impaired Breathing Pattern or Ventilation
Keywords: Mechanical ventilation
Weaning
Noninvasive ventilation
Acute respiratory failure
Helmet
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2011-03-24
Enrollment: 250
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 whether helmet is effective as device for noninvasive positive pressure ventilation in the weaning from mechanical ventilation.

Detailed description: The clinical efficacy of noninvasive positive pressure ventilation (NPPV) has been demonstrated. Interest has emerged in using NPPV to facilitate earlier removal of an endotracheal tube and decrease complications associated with prolonged intubation. Studies assessing NPPV in weaning are not enough and generally are performed with face masks as device for NPPV. This study assesses the efficacy of helmet as device for NPPV during weaning from mechanical ventilation in an ICU and compares this procedure with invasive mechanical complication (IMV) by analyzing respiratory parameters, clinical course and complications.

Eligibility criteria: Inclusion Criteria:

* endotracheal mechanical ventilation for 48 hours or more for acute respiratory failure,
* patient ready to be weaned (steady respiratory and hemodynamic conditions for 24 hours),
* spontaneous breathing trial failure
* written informed consent obtained (patient or family)

Exclusion Criteria:

* respiratory and hemodynamic instability
* initial difficult intubation
* bronchial hypersecretion at the weaning time
* non cooperant patient
* recent history of upper gastro-intestinal surgery
* recent history of myocardial infarction

Primary outcomes:
measure: Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure
timeFrame: 30 days
Secondary outcomes:
measure: Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure
timeFrame: 180 days
Other outcomes:
Locations:
city: Padova
country: Italy
facility: University Medical Hospital
Study officials:
affiliation: University medical hospital of Padova
name: Michele Carron, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carron M, Rossi S, Carollo C, Ori C. Comparison of invasive and noninvasive positive pressure ventilation delivered by means of a helmet for weaning of patients from mechanical ventilation. J Crit Care. 2014 Aug;29(4):580-5. doi: 10.1016/j.jcrc.2014.03.035. Epub 2014 Apr 5.
Clinical trial NCT00004559: Fatty Acid Antiarrhythmia Trial (FAAT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arrhythmia
Heart Diseases
Tachycardia, Ventricular
Ventricular Fibrillation
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-02-10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: To determine if the dietary N-3 class of polyunsaturated fatty acids (PUFAs) provided in the diet largely from marine fish oils would prevent fatal ventricular tachycardia (VT) or ventricular fibrillation (VF).

Detailed description: BACKGROUND:

Sudden death is a common manifestation of ischemic heart disease and therefore of great public health concern. Unfortunately several promising antiarrhythmic drugs proved not to be effective in preventing sudden deaths. This project would test whether a relatively inexpensive and presumably innocuous therapy, fish oil supplements, can prevent life-threatening arrhythmias. There is ample basic evidence that n-3 fatty acids contained in fish oil supplements may suppress arrhythmias, and a clinical trial seems warranted.

DESIGN NARRATIVE:

Prospective, randomized, placebo-controlled, double-blind. Patients were randomized to 4 grams per day of a PUFA fish oil supplement versus an olive oil placebo. The number of therapeutic discharges were recorded from the ICDs and then confirmed from the recorded electrocardiogram strips with the kinds of arrhythmias which had induced the ICD response. The primary end point, time to first ICD event for ventricular tachycardia or fibrillation (VT or VF) confirmed by stored electrograms or death from any cause, was analyzed by intention to treat.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Leaf A, Albert CM, Josephson M, Steinhaus D, Kluger J, Kang JX, Cox B, Zhang H, Schoenfeld D; Fatty Acid Antiarrhythmia Trial Investigators. Prevention of fatal arrhythmias in high-risk subjects by fish oil n-3 fatty acid intake. Circulation. 2005 Nov 1;112(18):2762-8. doi: 10.1161/CIRCULATIONAHA.105.549527.
Clinical trial NCT02578459: A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain
Official title: A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pain Management
Cancer Pain
Keywords: Cancer pain
Intrathecal therapy
Pain
Pancreatic cancer
Lead sponsor: Flowonix Medical
Sponsor class: INDUSTRY
First posted: 2015-10-19
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients with pancreatic cancer pain.

Detailed description: This study is a non-randomized, open-label, single-center study that will compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients suffering from pancreatic cancer pain.

There will be two treatment groups: Study group (ITDD): These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain. Systemic analgesics will not be prescribed for this group. Control group (CMM): These subjects will be treated with CMM to treat their pain.

A maximum of 30 subjects (maximum of 15 in each treatment group) may be enrolled in this study at one study center.

Eligibility criteria: Inclusion Criteria:

1. Patient has Stage IV pancreatic cancer.
2. Patient agrees not to be treated by other oncologists or anesthesiologists during the study.
3. Patient agrees not to obtain pain medications from other physicians during the study.
4. Patient is at least 22 years of age.
5. Investigator considers the patient to be able and willing to fulfill all study requirements.
6. Patient is able to understand the study and provide written informed consent to participate in the study.

Exclusion Criteria:

1. Patient meets any of the contraindications for use of the Prometra Programmable Infusion System (for patients in the ITDD group).
2. Patient is enrolled in another clinical study.

Primary outcomes:
measure: Visual Analog Scale Pain Scores
timeFrame: Three months
Secondary outcomes:
measure: Survival Rates
timeFrame: Two years
measure: Quality of Life Scores
timeFrame: Two years
measure: Cancer Treatments
timeFrame: Two years
measure: Hospitalizations and Emergency Room Visits
timeFrame: Two years
measure: Adverse Events
timeFrame: Two years
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Menorah Medical Center
state: Kansas
Study officials:
affiliation: Menorah Medical Center
name: Daniel R Kloster, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01031459: Telephone Interview of Patients That Participated in the the Pivotal Betaferon MS Trial.
Official title: An Observational 20-year, Cross-sectional, Long-term Follow up of the Patient Cohort Enrolled in the Pivotal Study of Betaseron® (Interferon Beta-1b) in Relapsing-remitting Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-12-14
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with MS that participated in the 16Y-LTF and Pivitol studies

Brief summary: The purpose of this study is to investigate the clinical status of patients who participated in the original pivotal Betaseron study at 20 years after randomized treatment initiationStudy end-points include:

1. Mortality - All-cause mortality - Cause specific mortality - Multiple sclerosis-related mortality
2. EDSS (Expanded Disability Status Scale)
3. Cognition
4. Resource use
5. SPMS (Secondary Progressive Multiple Sclerosis) status
6. Employment history


Eligibility criteria: Inclusion Criteria:

* Previously enrolled in the Betaseron pivotal study protocols TB01-35686 in the US and TB01-35886 in Canada (total, N=372)
* Patient, caregiver, or legal guardian must provide written informed consent
* Patient must confirm her/his ability and agreement to participate in the study at the beginning of the phone call

Primary outcomes:
measure: Descriptive exploration of mortality, EDSS, cognition, resource use, SPMS status and employment history by length of exposure to Betaseron and stratified by the original clinical trial group assignment (1.6 MIU, 8 MIU, placebo)
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: San Francisco
country: United States
state: California
city: Chicago
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Philadelphia
country: United States
state: Pennsylvania
city: Vancouver
country: Canada
state: British Columbia
city: London
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02336659: Influence of Gut Hormones on Food Intake After Roux-en-Y Gastric Bypass Surgery
Official title: Influence of Gut Hormones on Food Intake After Roux-en-Y Gastric Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Obesity
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2015-01-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to examine the effect of GLP-1 and other gut-secreted hormones (glucagon, GIP, grelin and PYY) on food-intake, appetite and glucose metabolism after Roux-en-Y gastric bypass surgery.

Detailed description: To do this the effect of combined GLP-1 receptor blockade by Exendin 9-39 and DPP-4-inhibition will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Uncomplicated RYGB performed 3-12 month proir to the study. Fasting plasma glucose \<7.0 mM and HbA1c \< 48 mmol/mol 3 month after RYGB.

Exclusion Criteria:

* Fasting plasma glucose \>7.0 mM and HbA1c \> 48 mmol/mol 3 month after RYGB. Hemoglobin \<6.5mM. Previous anaphylaxis when treated with Januvia or Byetta. Allergy for sitagliptin. Dysregulated hypothyroidism. Use of antithyroid treatment. Late diabetic complications as retinopathy, renal insuffiency, neuropathy or previous pancreatitis. Bad compliance.
* Complications to RYGB: Documented reactive hypoglycaemia, severe dumping (with vomiting, diarrhea or severe abdominal pain after food intake).

Primary outcomes:
measure: Ad libitum food intake (changes in food intake)
timeFrame: 3-12 month after RYGB
Secondary outcomes:
measure: Glucose metabolism (iAUC of glucose and c-pep after a meal)
timeFrame: 3-12 month after RYGB
measure: Gut-derived hormone profiles (iAUC of GLP-1, PYY, GIP and glucagon after a meal)
timeFrame: 3-12 month after RYGB
measure: Appetite measurement (VAS-scores)
timeFrame: 3-12 month after RYGB
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Sten Madbad, MD, DMSc
role: STUDY_CHAIR
References:
Clinical trial NCT00937859: Treatment of Patients With Nocturia
Official title: A Phase III Randomized, Double Blind, Placebo Control, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nocturia
Lead sponsor: Serenity Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-13
Enrollment: 301
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 purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that SER120 will decrease the number of nocturic episodes compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Male and female 50 years or older
* Nocturia of 6 or more months duration averaging 2 episodes or more per night

Exclusion Criteria:

* CHF
* Diabetes
* Diabetes Insipidus
* Renal Insufficiency
* Hepatic Insufficiency
* Incontinence
* Illness requiring steroids
* Current or past urologic malignancy
* Nephrotic Syndrome
* Unexplained pelvic masses
* Urinary bladder neurological dysfunction
* Urinary bladder surgery or radiotherapy
* Sleep Apnea
* Pregnant or breast feeding

Primary outcomes:
measure: Change in Mean Number of Nocturic Episodes/Night
timeFrame: 7 weeks
measure: Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night
timeFrame: 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Piedmont Medical Research Assoc.
state: North Carolina
Study officials:
References:
Clinical trial NCT01225159: Tight Glycaemic Control During Cardiac Surgery
Official title: Safety and Efficacy of Tight Glycaemic Control During Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nosocomial Infection
External Causes of Morbidity and Mortality
Hypoglycemia
Keywords: tight glycemic control
cardiac surgery
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2010-10-20
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine whether intraoperative tight glycaemic control can reduce postoperative infection, morbidity and mortality

Detailed description: Hyperglycaemia develops frequently in patients undergoing cardiac surgery, especially following cardiopulmonary bypass (CPB). Recent evidence suggests that acute hyperglycaemia adversely affects immune function, wound healing and cardiovascular function.

Eligibility criteria: Inclusion Criteria:

* age \> 15 years
* cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* active infection
* insulin allergy
* off-pump cardiopulmonary bypass procedures

Primary outcomes:
measure: Nosocomial Infection
timeFrame: within the first 30 day after surgery
Secondary outcomes:
measure: Morbidities and All Causes Mortality
timeFrame: within the first 30 days after surgery
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Songklanagarind Hospital, Faculty of Medicine, PSU
state: Songkhla
Study officials:
affiliation: Faculty of Medicine, Prince of Songkla University
name: Panthila Rujirojindakul, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06470659: Medications With or Without WeightWatchers
Official title: Effectiveness of a Telehealth Medical Weight Management Program Prescribing Anti-obesity Medications Paired With a Digital Behavioral Weight Management Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Lead sponsor: WW International Inc
Sponsor class: INDUSTRY
First posted: 2024-06-24
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study compares the effectiveness of adults living with overweight or obesity taking weight management medications alone vs taking them with behavioral and lifestyle support. The primary outcome is percent body weight lost at 12-weeks.


Eligibility criteria: Inclusion Criteria:

* BMI of \>30 or BMI of \>27 with one or more weight related medically qualifying condition (hypertension, dyslipidemia, sleep apnea, cardiovascular disease)
* Determined eligible for Bupropion/Naltrexone or Liraglutide by WW Clinic medical provider and initiated a medication management plan

Exclusion Criteria:

* Diabetes
* Uncontrolled hypertension
* History of seizures
* History of glaucoma
* History of chronic kidney disease
* Currently taking bupropion
* Currently taking naltrexone
* Current or previous history of anorexia or bulimia nervosa
* Engagement with vomiting or laxative use within the last 28 days with the aim of controlling their shape or weight
* Currently taking opioids
* Previous surgical obesity treatment
* Use of other anti-obesity medication in last 90 days or a GLP1 in the last 180 days
* Lost weight \>11 lbs in the last 90 days
* Pregnant, breastfeeding, intends to become pregnant, of child-bearing potential and not using a highly effective contraceptive method
* Any other reason rendering a participant unsuitable for trial participation, as determined by a clinician or study investigator

Primary outcomes:
measure: Percent body weight lost at 12 weeks
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change in body weight (in kg or pounds) at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Physical Activity and Sedentary Behavior
timeFrame: Baseline, 12 weeks
measure: Dietary Intake
timeFrame: Baseline, 12 weeks
measure: Habit/Automaticity
timeFrame: Baseline, 12 weeks
measure: Hunger VAS (Visual Analogue Scale)
timeFrame: Baseline, 12 weeks
measure: Impact on Quality of Life
timeFrame: Baseline, 12 weeks
measure: Well-being
timeFrame: Baseline, 12 weeks
measure: Body Appreciation
timeFrame: Baseline, 12 weeks
measure: Food Cravings
timeFrame: Baseline, 12 weeks
measure: Self-Compassion
timeFrame: Baseline, 12 weeks
measure: Weight Bias
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: NYC
country: United States
facility: WW International, Inc
state: New York
Study officials:
affiliation: WW International Inc
name: Michelle Cardel, PhD, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: WW International Inc
name: Rebecca Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: