louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00921141: Assessment of Complications, Quality of Life and Easiness of Use of Implantable Central Venous Access Ports
Official title: Assessment of Complications, Quality of Life and Easiness of Use of Implantable Central Venous Access Ports : Cohort and Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Implantable central venous access ports, cancer
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2009-06-16
Enrollment: 815
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: All the patients requiring the implementation of a catheter in an anticancerous center

Brief summary: This is a prospective, descriptive and observational study of the anticancer center practice


Eligibility criteria: Inclusion Criteria:

* Patient with any cancer, requiring a central venous catheter
* No contraindication for any surgery with local or complete anaesthesia

Exclusion Criteria:

* Previous Xylocaine or Lidocaine allergy
* Clinic superior vena cava syndrome

Primary outcomes:
measure: Incidence and collection of complications for the patients requiring an implantable central venous access ports substitution/change
timeFrame: Until the implantable central venous access ports removal
Secondary outcomes:
measure: Brief description of the different risk factor for morbidity
timeFrame: Until the implantable central venous access ports removal
measure: Assessment of the implantable central venous access ports ease-of-use for nurses according to the modalities of implementation and patient features
timeFrame: Until the implantable central venous access ports removal
measure: Assessment of the patient quality of life
timeFrame: Before central venous access ports implementation, at the first day of chemotherapy, and during the cycle 4 of chemotherapy
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
affiliation: Centre Oscar Lambret
name: Fabrice NARDUCCI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02446041: ICS/LABA Adherence and COPD Exacerbation
Official title: Adherence and COPD Exacerbation Rates in Patients Initiating ICS/LABA Therapy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease
Chronic Obstructive
Keywords: COPD
Chronic Bronchitis
Pulmonary Emphysema
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Carelon Research
First posted: 2015-05-15
Enrollment: 10000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICS/LABA patients with administrative claims data from health plans in the Northeast, Midwest, South and West United States.

Brief summary: The purpose of this retrospective, non-interventional sutdy is to compare the effectiveness of ICS/LABA combination therapy in the reduction of COPD exacerbations during the 12 months after initiation of therapy between COPD patients who are adherent to the index medication and those who are non-adherent.

Detailed description: This retrospective, observational study will assess the effectiveness of ICS/LABA combination therapies among COPD patients new to the ICS/LABA combination therapies in the US, comparing those who are adherent to the index medication and those who are non-adherent. Adherence will be measured using the proportion of days covered with the index medication. Medical and pharmacy claims data will be used as the data source.

Eligibility criteria: Inclusion Criteria:

* at least one prescription fill for ICS/LABA combination during identification period.
* COPD diagnosis
* 40 years or older at index date
* \> or = 12 months of continuous health plan enrollment prior to and following index date
* 1 or more prescription for SABA, SAMA or SABA/SAMA during the pre-index period.

Exclusion Criteria:

* Patients with prescription claim for ICS/LABA combination therapy during the 12 month pre-index period
* Patients receiving oral corticosteroid medication for more than 180 days during the 12 month pre-index period
* Patients with cancer diagnosis in 12 month pre-index period

Primary outcomes:
measure: Exacerbation rate
timeFrame: 12 months
Secondary outcomes:
measure: Severe Exacerbation rate
timeFrame: 12 months
Other outcomes:
measure: Time to Exacerbation
timeFrame: 12 months
Locations:
city: Wilmington
country: United States
facility: Research Facility
state: Delaware
Study officials:
affiliation: AstraZeneca
name: Frank Trudo, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00753441: Endoscopic Stenting Versus Surgical Bypass for Low Bile Duct Obstruction by Cancer of the Pancreatic Head
Official title: Endoscopic Biliary Stenting on Demand Versus Surgical Biliary Bypass for Palliation of Patients With Advanced Cancer of the Pancreatic Head: STENTBY - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Pancreatic cancer
Bile duct obstruction
Stent
Bypass
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2008-09-16
Enrollment: 24
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 prognosis of patients with unresectable pancreatic cancer is dismal. Hence, palliation of tumor-associated symptoms, in particular jaundice due to low bile duct obstruction and gastric outlet obstruction, is the primary aim of these patients' care. Endoscopic stenting and surgical bypass are currently the two competing treatment options. There is currently no randomized trial comparing the recently developed metal stents to surgical bypass. Furthermore, there is very limited data on quality of life of these patients receiving either therapy. While endoscopic stenting represents the less invasive treatment, surgery may provide better long-term control requiring one-time treatment. Due to the incomplete evidence the present randomized controlled trial is designed to compare quality of life of patients undergoing endoscopic stenting on demand or surgical bypass for palliation of symptoms caused by cancer of the pancreatic head requiring with low bile duct obstruction.


Eligibility criteria: Inclusion Criteria:

* Age equal or greater than 18 years
* Diagnosis of unresectable cancer of the pancreatic head (after clinical, laboratory, radiological assessment) requiring palliative treatment for biliary obstruction. In unclear cases an exploratory laparotomy will be performed and resectability will be evaluated intraoperatively
* Operability certified by anesthesiologist
* Written informed consent

Exclusion Criteria:

* Intervention technically/medically not feasible
* Expected lack of compliance
* One treatment option considered to be clearly in favor of the patient

Primary outcomes:
measure: Quality of life
timeFrame: 12 months
measure: Serum bilirubin
timeFrame: 12 months
Secondary outcomes:
measure: Procedure-related complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Universityhospital Heidelberg
Study officials:
affiliation: Department of General, Visceral and Transplantation Surgery, University of Heidelberg
name: Bruno Schmied, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05837741: Leucine-enriched Formulas in Patients With Tumor-induced Sarcopenia
Official title: Standard Hypercaloric, Hyperproteic vs Leucine-enriched Oral Supplements in Patients With Cancer-induced Sarcopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Cancer
Keywords: Sarcopenia
Cancer
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Currently there is a lack of evidence for recommending specific oral supplements (OS) for nutritional support in patients with cancer, including leucine-enriched supplements.

Detailed description: Appropriate clinical trials that compare anthropometric and biochemical changes in nutritional parameters and clinical outcomes in patients with cancer-induced sarcopenia are required

Eligibility criteria: Inclusion Criteria:

* patients of both sexes, age \> 18 y-old
* cancer of different origin treated with systemic treatment chemo, radiotherapy or combination treatment t
* weight loss \>5% during the previous three months or \>10% during the previous six months

Exclusion Criteria:

* end-stage kidney disease
* life expectancy \< 2 weeks

Primary outcomes:
measure: Muscle mass gain
timeFrame: 3 Months
Secondary outcomes:
measure: Fat mass change
timeFrame: 3 Months
measure: Phase angle change
timeFrame: 3 Months
measure: Changes in albumin
timeFrame: 3 Months
measure: Changes in prealbumin
timeFrame: 3 Months
measure: Changes in CRP
timeFrame: 3 Months
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: IMIBIC
state: Cordoba
Study officials:
affiliation: IMIBIC-HURS
name: Aura D Herrera Martinez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06894641: A Randomized Control Trial of Enhanced Cognitive Behavioural Group Therapy for Older Adults with Depression: Efficacy Across Older Age-Groups
Official title: A Randomized Control Trial of Enhanced Cognitive Behavioural Group Therapy for Older Adults with Depression: Efficacy Across Older Age-Groups
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Major Depression
Keywords: CBT
CBT-OA
Depression
Major Depression
Major Depressive Disorder
Cognitive Behavior Therapy
Older Adults
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is on a type of psychotherapy to treat depression in older adults called Cognitive Behavioural Therapy (CBT-OA). CBT is based on the idea that changing thoughts and behaviours can improve mood. CBT has been shown to treat depression in many types of people. CBT-OA changes the usual approaches used for older adults and offers the therapy in a group settings for 8 weeks, for 2 hours a week.

Participants will be randomly (by chance) placed into one of two study groups. One group will receive CBT-OA treatment right away. The other group (Treatment As Usual) will receive standard care from their doctor during the 12-week study period. Both groups will be closely monitored during the study period. The standard care group will be offered CBT-OA in a future session outside of the study.


Eligibility criteria: Inclusion Criteria:

* Ambulatory patients 65+ years of age and diagnosed with MDE per DSM-V criteria by a geriatric psychiatrist using a standard clinical biopsychosocial assessment and a Beck Depression Inventory (BDI) of \>12.

Exclusion Criteria:

* Patients with psychosis, those undergoing acute inpatient care or electroconvulsive therapy (ECT), those with dementia (Mini-Mental Status Examination (MMSE) score of \< 26), and those with chronic personality disorders

Primary outcomes:
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01562041: Evaluation of Exercise Treadmill Test (ETT) Indices in Participants With Cardiovascular Disease
Official title: Evaluation of Exercise Treadmill Test Indices in Patients With Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atherosclerotic Coronary Vascular Disease
Keywords: Cardiovascular disease
Exercise Treadmill Test
Ranolazine
Angina
Myocardial ischemia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-03-23
Enrollment: 14
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study was designed to evaluate the use of ETT electrocardiogram (ECG) indices as biomarkers in the assessment of atherosclerotic coronary vascular disease (ASCVD).


Eligibility criteria: Inclusion Criteria:

* History of stable coronary artery disease

Exclusion Criteria:

* Inability or unwillingness to participate in multiple exercise treadmill tests and/or any other requirements of this study as assessed by the Investigator.

  * History of chronic atrial fibrillation.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in Maximum ST Segment Change Adjusted for Heart Rate (ST-HR) Index
timeFrame: Baseline up to Day 15
measure: Change From Baseline in Maximum ST Segment Change Adjusted for Heart Rate (ST-HR) Slope
timeFrame: Baseline up to Day 15
measure: Change From Baseline in X-Axis Intercept of ST-HR Slope
timeFrame: Baseline up to Day 15
Secondary outcomes:
measure: Change From Baseline in Total Exercise Duration
timeFrame: Baseline up to Day 15
measure: Change From Baseline in Time to Onset of 1 mm ST Segment Depression (Time to Ischemia)
timeFrame: Baseline up to Day 15
measure: Change From Baseline in Time to Onset of Angina
timeFrame: Baseline up to Day 15
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Novartis Investigative Site
state: Florida
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT05602519: The Analgesic Efficacy of Oxycodone Hydrochloride Versus Fentanyl After Total Hip Arthroplasty:
Official title: The Analgesic Efficacy and Safety of Oxycodone Hydrochloride Versus Fentanyl After Total Hip Arthroplasty: A Randomized Triple-Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Hip Arthroplasty
The Analgesic Efficacy
Keywords: Oxycodone Hydrochloride
Fentanyl
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 72
Sex: ALL
Minimum age (years): 28
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Oxycodone showed similar or superior analgesic effects than fentanyl and was proposed as an alternative for fentanyl for pain control in the postoperative period. However, it was mainly directed to control visceral pain, due to the mediation of analgesic effects by the kappa receptors. However, few studies compared the oxycodone to fentanyl for postoperative pain relief in patients undergoing total hip arthroplasty (replacement). Therefore, we established this randomized study to compare the efficacy of oxycodone and fentanyl for relief of postoperative pain after total hip arthroplasty (replacement).


Eligibility criteria: Inclusion Criteria:

* Patients aged 28-62 years old,
* Both genders, American Society of Anesthesiologists (ASA) physical status classification I or II who scheduled for elective total hip surgery.

Exclusion Criteria:

* Patients with history of any kind of drug allergy.
* drug abuse.
* psychological or other emotional problems,
* renal and hepatic chronic disease.

Primary outcomes:
measure: Improving A post-anesthesia care unit (PACU) pain score.
timeFrame: 48 hours
Secondary outcomes:
measure: Hemodynamics
timeFrame: 48 hours
measure: Postoperative side effects
timeFrame: 48 hours
measure: Postoperative consumption of opioid
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Damieta
country: Egypt
facility: Facualty of Medicine (Damietta), Al Azhar University
Study officials:
References:
Clinical trial NCT06993519: Impact of Minimally Non-surgical Periodontal Treatment on Residual Pockets
Official title: Effects of Minimally Non-surgical Periodontal Treatment Versus Quadrantwise Subgingival Instrumentations on Residual Periodontal Pockets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pocket, Periodontal
Periodontitis
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-surgical periodontal treatment Subgingival biofilm ultrasonic debridement with MINST or Q-SI for residual pockets
Primary purpose: TREATMENT

Brief summary: A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment by means of minimally invasive approach MINST or Q-SI (quadrantwise) approach in subjects with periodontitis on residual pockets after active periodontal treatment

Detailed description: A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment in subjects with periodontitis. 60 patients: 30 with periodontitis and 30 healthy controls who underwent active periodontal treatment. All the patients are assessed for clinical, periodontal, blood following of minimally invasive approach MINST or Q-SI (quadrantwise).

Measurements are taken before and after initial periodontal treatment in the periodontal subjects in order to evaluate the best treatment for residual pockets.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Periodontitis
* Presence of residula periodontal pockets

Exclusion Criteria:

* Periodontal treatment
* Use of antibiotics, NSAIDs, and immunosuppressants during the last 6 months
* Pregnancy

Primary outcomes:
measure: Probin Pocket Depth reduction
timeFrame: 1-year
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Policlinico G. Rodolico
Study officials:
affiliation: Università degli Studi di Catania - Dipartimento di Chirurgia Generale e Specialità Medico-Chirurgiche
name: Gaetano Isola, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01012219: A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination (MK-0524A-114)(COMPLETED)
Official title: A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination and to Evaluate Single Dose Pharmacokinetics of MK0524A in Subjects With Primary Hypercholesterolemia or Mixed Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Primary Hypercholesterolemia
Mixed Hyperlipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-11-11
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a 3-period study. Periods 1 and 2 will evaluate the effects of multiple doses of laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3 will be open-label and will evaluate single dose pharmacokinetics of nicotinic acid and laropiprant components of Tredaptive.


Eligibility criteria: Inclusion Criteria:

* Participant has primary hypercholesterolemia or mixed dyslipidemia (high cholesterol)
* Participant is a non-smoker

Exclusion Criteria:

* Participant has a history of chronic seizures
* Participant has a history of cancer
* Participant has a history of stomach or intestinal ulcers or any history of GI bleeding
* Participant has had major surgery, donated blood or participated in another investigational study in the past 4 weeks

Primary outcomes:
measure: Cutaneous Bleeding Time (BT)
timeFrame: Day 8
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: De Kam PJ, Luo WL, Wenning L, Ratcliffe L, Sisk CM, Royalty J, Radziszewski W, Wagner JA, Lai E. The effects of laropiprant on the antiplatelet activity of co-administered clopidogrel and aspirin. Platelets. 2014;25(7):480-7. doi: 10.3109/09537104.2013.836747. Epub 2013 Nov 8.
Clinical trial NCT02832219: Medium-term Effects of Molecular Hydrogen on Metabolic Fitness in Obesity
Official title: Medium-term Effects of Molecular Hydrogen on Metabolic Fitness in Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Keywords: Overweight
Molecular hydrogen
Insulin
Lead sponsor: Center for Health Sciences, Serbia
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 12
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Molecular hydrogen (H2) effectively tackles obesity-related disorders in animal models yet no studies so far investigated the effectiveness of H2 for improving biomarkers of obesity in humans. In this double blind, placebo-controlled, crossover pilot trial, the investigators will evaluate the effects of H2 intervention on body composition, hormonal status, and mitochondrial function in middle age overweight women, with hydrogen administered orally for 4 weeks.


Eligibility criteria: Inclusion Criteria:

* age \> 55 years
* body mass index \> 25 kg/m2

Exclusion Criteria:

* no history of H2 supplementation within the 4 weeks before study commenced
* no major chronic diseases, as evaluated by pre-participation health screening and clinical chemistry

Primary outcomes:
measure: Body fat percentage change
timeFrame: Baseline vs. four weeks
Secondary outcomes:
measure: Serum insulin change in IU/mL
timeFrame: Baseline vs. four weeks
Other outcomes:
measure: Serum ghrelin change in IU/mL
timeFrame: Baseline vs. four weeks
Locations:
city: Belgrade
country: Serbia
facility: Center for Health, Exercise and Sport Sciences
Study officials:
References:
citation: Ostojic SM. Molecular hydrogen: An inert gas turns clinically effective. Ann Med. 2015 Jun;47(4):301-4. doi: 10.3109/07853890.2015.1034765. Epub 2015 May 4.
citation: Huang CS, Kawamura T, Toyoda Y, Nakao A. Recent advances in hydrogen research as a therapeutic medical gas. Free Radic Res. 2010 Sep;44(9):971-82. doi: 10.3109/10715762.2010.500328.
citation: Korovljev D, Trivic T, Drid P, Ostojic SM. Molecular hydrogen affects body composition, metabolic profiles, and mitochondrial function in middle-aged overweight women. Ir J Med Sci. 2018 Feb;187(1):85-89. doi: 10.1007/s11845-017-1638-4. Epub 2017 May 30.