louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00966459: Computed Tomography (CT) and Lung Function Data Collection for Computational Fluid Dynamics (CFD) in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: Computed Tomography (CT) and Lung Function Data Collection for Computational Fluid Dynamics (CFD) in COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2009-08-27
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this study, 20 COPD patients will undergo a high-resolution/multi slice CT scan and lung function tests to obtain patient specific geometries of the central and peripheral small airways and patient specific boundary conditions.

With Computational Fluid Dynamics (CFD), the investigators will be able to reconstruct the geometry and measure the resistance of the peripheral airways.

In a later stage, CFD will be used to simulate the reaction of the airways on various inhalation medications.


Eligibility criteria: Inclusion Criteria:

1. Patients with documented COPD based on the following criteria:

   * Smoking history of at least 10 pack-years.
   * Decreased Tiffeneau index (FEV1/(F)VC \< 0.70).
2. Patients aged ≥ 40 years.
3. Patients should present moderate to very severe COPD with an FEV1 \< 80% of predicted (GOLD 2, 3 and 4).
4. Patients should be treated according to GOLD guidelines.
5. Maintained on stable respiratory medications for 4 weeks prior to visit 1
6. Able to perform lung function tests.

Exclusion Criteria:

1. Patients below the age of 40.
2. Patients who are pregnant or are breast-feeding.
3. A respiratory infection or exacerbation of COPD in the four weeks prior to screening.
4. BMI \> 35 kg/m².
5. Patients treated with BiPAP or CPAP.
6. Known active tuberculosis.
7. A history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
8. A history of thoracotomy with pulmonary resection.
9. Active or untreated malignancy.

Primary outcomes:
measure: To obtain patient specific geometries of the central and peripheral small airways
measure: To obtain patient specific boundary conditions
Secondary outcomes:
measure: To measure the resistance of the peripheral airways
measure: To measure the reaction of the airways on various inhalation medications
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
Study officials:
References:
Clinical trial NCT00376259: Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone
Official title: An Open-label, Multicenter, Randomized Study of Combination Therapy With Oral LDT600 (Telbivudine) Plus Adefovir Dipivoxil Versus Adefovir Dipivoxil Alone in HBeAg-positive Patients With Chronic Hepatitis B Who Are Lamivudine Resistant
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: lamivudine resistance
Hepatitis B virus
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-09-14
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration \[FDA\] for the treatment of hepatitis B virus \[HBV\]) versus adefovir dipivoxil used alone. The results for patients taking the combination therapy will be compared to the results for patients taking adefovir alone.


Eligibility criteria: Inclusion Criteria:

* Documented compensated chronic hepatitis B defined by a clinical history compatible with chronic hepatitis B.
* Previous or current lamivudine treatment
* HBV DNA \> 6 log10 copies/mL
* Evidence of viral breakthrough

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Patient is pregnant or breastfeeding.
* Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV.
* Patient has received any anti-HBV treatment for HBV infection other than lamivudine in the 12 months before Screening for this study.

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: The Proportion of Participants Who Experienced Virologic Breakthrough
timeFrame: 96 Weeks
Secondary outcomes:
measure: Change From Baseline in Mean Hepatitis B Virus (HBV) DNA Concentration
timeFrame: Baseline to 12 weeks, 24 weeks, 48 weeks and 60 weeks
measure: Percentage of Participants Achieving Specified Clinical and Laboratory Safety Criteria
timeFrame: 12 week, 24 week, 48 week and 60 weeks
measure: Proportion of Participants With Treatment-emergent HBV Resistance Mutations Associated With Virologic Breakthrough
timeFrame: Week 96
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Novartis
state: California
city: San Mateo
country: United States
state: California
city: Pok Fu Lam
country: Hong Kong
city: Seoul
country: Korea, Republic of
city: Kaohsuing
country: Taiwan
facility: Novarits
city: Bangkok
country: Thailand
Study officials:
References:
Clinical trial NCT06605859: DigiDiab Pilot Spain - Nursing Home and Domiciliary Nursing Care
Official title: An Open, Multicentre, Prospective, Non-interventional Study of the CE-marked Medical Device GlucoTab in Nursing Homes and Domiciliary Nursing Care, According to Intended Use Without Additional Invasive and Stressful Measures
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type 2 Diabetes
Keywords: GlucoTab
Type 2 Diabetes
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2024-09-20
Enrollment: 40
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: Non-critically ill patients with type 2 diabetes in the participating nursing homes/domiciliary nursing care who require s.c. insulin therapy

Brief summary: GlucoTab is a stand-alone software system to support healthcare professionals in the care of patients with diabetes mellitus or newly diagnosed hyperglycaemia who are treated with insulin and/or other glucose-lowering drugs or of patients only requiring glucose monitoring.

It provides a therapy algorithm for subcutaneous basal insulin therapy of patients with type 2 diabetes, which will be used in this study.

Detailed description: GlucoTab: The CE-marked medical device GlucoTab is a system designed to support healthcare personnel in managing insulin therapy for patients with diabetes.

In this study, only the GlucoTab algorithm supported basalinsulin therapy will be used, which is intended for patients with Type 2 diabetes in domiciliary nursing care and nursing homes requiring insulin therapy.

Eligibility criteria: Inclusion Criteria:

* Elderly people, willing to be treated with a basal insulin therapy according to the GlucoTab system
* Informed consent obtained after being advised of the nature of the study
* Male or female aged ≥ 18 years
* Type 2 diabetes (treated with insulin therapy)
* Residents of participating nursing homes/domiciliary nursing care in the region of Camp de Tarragona (Spain).

Exclusion Criteria:

* type 1 diabetes mellitus
* intravenous insulin therapy
* hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy
* continuous subcutaneous insulin infusion
* gestational diabetes or pregnancy
* known or suspected allergy to insulin
* total parenteral nutrition
* any mental condition rendering the patient incapable of giving his/her consent
* any disease or condition which according to the investigator would interfere with the trial or the safety of the patient

Primary outcomes:
measure: Efficacy
timeFrame: ≥ 24 hours after start of the therapy by using the GlucoTab system
Secondary outcomes:
measure: Usability
timeFrame: at the end of the study, on average three months
measure: Safety
timeFrame: at the end of the study, on average three months
measure: Efficacy
timeFrame: at the end of the study, on average three months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06042959: Effects of Laughter Yoga Practiced by Nursing Students Before Clinical Practice
Official title: Effects of Laughter Yoga Practiced by First Year Nursing Students Before Clinical Practice on Their Perceptions of Stress and Meaning of Life: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Laughter
Stress
Keywords: Laughter therapy
Nursing
Students
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: We conducted this randomized controlled study to determine the effect of laughter yoga practiced by first year nursing students before clinical practice on their perceptions of stress and meaning of life.

Background: Laughter yoga has a positive effect on the person's mental/general health, life satisfaction and psychological well-being and enables the person to cope with stress.

Design: In this experimental randomized and controlled study including a control group, we administered a pre-test, post-test one and post-test two to the participating students.

Methods: We conducted the study with 45 first year nursing students in the intervention group, and 45 first year nursing students in the control group. The students in the intervention group took part in eight sessions of laughter yoga for four weeks, twice a week. We used the Descriptive Information Form, Perceived Stress Scale, and Meaning and Purpose of Life Scale to collect the study data.


Eligibility criteria: Inclusion Criteria:

* Who did not have any diagnosed psychiatric diseases,
* Who had not done laughter yoga and / or did not have any clinical experience previously were included

Exclusion Criteria:

* Who withdrew from the study at any stage,
* Those who did not participate in the yoga sessions regularly
* Those who used another relaxation method during this period,
* Those who took antidepressants,
* Those who had a chronic cough and / or urinary incontinence,
* Those who underwent surgery in the last 3 months (abdominal surgery, uncontrolled surgery, glaucoma, hernia),
* Those who had neurological diseases such as epilepsy, multiple sclerosis,
* Those who were unwilling to participate in the study,
* Those who had neurological disorders,
* Those who lost one of their loved ones in the last 6 months were excluded from the research.

Primary outcomes:
measure: Meaning and Purpose of Life
timeFrame: four weeks
measure: Stress
timeFrame: four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Manisa
country: Turkey
facility: Manisa Celal Bayar University
state: Yunusemre
Study officials:
References:
Clinical trial NCT00092300: A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-181)(COMPLETED)
Official title: A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Single Dose Study of the Effect of Rofecoxib 50 mg and Valdecoxib 20 mg in Patients With Postoperative Dental Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Keywords: dental surgery
molar removal
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-09-28
Enrollment: 450
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.

Detailed description: The duration of treatment is 1 day.

Eligibility criteria: Inclusion Criteria:

* Impaction of a molar tooth requiring removal

Exclusion Criteria:

* Known allergies to the study drug

Primary outcomes:
measure: Overall analgesic effect over 12 hours.
Secondary outcomes:
measure: Overall analgesic effect over 8 hours.
measure: Time to onset of analgesic, peak analgesic and duration of analgesic effects.
measure: Overall analgesic, time to onset of analgesic, peak analgesic, and duration analgesic effects
measure: Safety and tolerability.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Daniels SE, Desjardins PJ, Bird SR, Smugar SS, Tershakovec AM. Rofecoxib 50 mg and valdecoxib 20 or 40 mg in adults and adolescents with postoperative pain after third molar extraction: results of two randomized, double-blind, placebo-controlled, single-dose studies. Clin Ther. 2006 Jul;28(7):1022-34. doi: 10.1016/j.clinthera.2006.07.005.
Clinical trial NCT01102400: A Study of MEDI-575 in Patients With Advanced Solid Malignancies
Official title: A Phase I, Open-Label Study to Assess the Safety, Tolerability and Pharmacokinetics of Ascending Doses of MEDI-575 in Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Malignancies
Keywords: cancer
tumor
hepatocellular carcinoma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: MedImmune LLC
First posted: 2010-04-13
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of MEDI-575 in Japanese patients with advanced solid tumors (dose escalation part) and hepatocellular carcinoma (expansion part).


Eligibility criteria: Inclusion Criteria:

* Having advanced solid malignancy for which no curative or standard therapies exist
* Karnofsky performance status of ≥60
* Patients must have histological confirmed diagnosis of HCC with no standard therapy available (for only expansion part)

Exclusion Criteria:

* Inadequate bone marrow reserve or organ function
* Major surgery within 4 weeks or minor surgery within 2 weeks prior to receipt of MEDI-575. Patients must have no unhealed wounds or unhealed fractures
* History of allergy or reaction to any component of the MEDI-575 and/or monoclonal antibody

Primary outcomes:
measure: Safety and tolerability assessed primarily by adverse events including abnormal values of clinical laboratory test, ECG and vital sign
timeFrame: 30 days after the last dose of MEDI-575
Secondary outcomes:
measure: Pharmacokinetic variables of MEDI-575 by assessment of drug concentrations in serum after intravenous infusion
timeFrame: 30 days after last dose of study drug
measure: To evaluate the immunogenicity of MEDI-575 by measuring anti-MEDI-575 antibodies
timeFrame: 3 months after last dose of study drug
measure: Anti-tumor activity of MEDI-575 using Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 3 months after last dose of study drug
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Kashiwa
country: Japan
facility: Research Site
state: Chiba
city: Matsuyama
country: Japan
facility: Research Site
state: Ehime
city: Chuo-ku
country: Japan
facility: Research Site
state: Tokyo
city: Sunto-gun
country: Japan
facility: Research Site
Study officials:
References:
citation: Murakami H, Ikeda M, Okusaka T, Inaba Y, Iguchi H, Yagawa K, Yamamoto N. A Phase I study of MEDI-575, a PDGFRalpha monoclonal antibody, in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Sep;76(3):631-9. doi: 10.1007/s00280-015-2832-6. Epub 2015 Jul 30.
Clinical trial NCT00678600: Study of Provider Computer Alerts Designed to Improve Delivery of HIV Care
Official title: Optimizing HIV Disease-Specific Provider Alerts: A Randomized Controlled Informatics Trial Comparing Electronic Health Record (EHR) vs. Non-EHR Provider Alerts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Informatics
Alerts
Toxicity
Virologic failure
Suboptimal follow up
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Harvard Medical School (HMS and HSDM)
name: Massachusetts General Hospital
First posted: 2008-05-15
Enrollment: 1011
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_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 alerts independent of the ambulatory health record are more effective in eliciting physician responses and therefore have greater impact on HIV disease outcomes than traditional static alerts.

Detailed description: This study will compare the effectiveness of standard and enhanced care alerts in HIV infected participants at Massachusetts General Hospital in Boston, Massachusetts.

Participants will be a part of this study for 4 years or until they are no longer followed at Massachusetts General Hospital. Participants will be assigned randomly to one of two arms. Participants assigned to Arm 1 will receive standard care, involving standard provider alerts which will be posted on the participant's health record. Participants assigned to Arm 2 will receive enhanced care, involving improved functionality. Experimental informatics-based provider alerts and support systems will be used to develop a pilot system designed to optimize delivery of HIV clinical care.

All participants will be monitored for new laboratory toxicities, suboptimal follow up, and virologic failure at their normally scheduled appointments.

Eligibility criteria: Inclusion Criteria:

* HIV infected
* Followed in the Massachusetts General Hospital HIV clinic.

Exclusion Criteria:

Primary outcomes:
measure: Change in CD4 count
timeFrame: Throughout study
Secondary outcomes:
measure: Time to repeat laboratory testing
timeFrame: Throughout study
measure: Time to follow up appointment
timeFrame: Throughout study
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Gregory K Robbins, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robbins GK, Lester W, Johnson KL, Chang Y, Estey G, Surrao D, Zachary K, Lammert SM, Chueh HC, Meigs JB, Freedberg KA. Efficacy of a clinical decision-support system in an HIV practice: a randomized trial. Ann Intern Med. 2012 Dec 4;157(11):757-66. doi: 10.7326/0003-4819-157-11-201212040-00003.
Clinical trial NCT03363100: Diabetes Coaching Program for Medicare Advantage Members With Type 2 Diabetes - Impact on A1c
Official title: Diabetes Coaching Program for Medicare Advantage Members With Type 2 Diabetes - Impact on A1c
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Evidation Health
Sponsor class: INDUSTRY
Collaborators: name: Humana Co.Ltd.
First posted: 2017-12-06
Enrollment: 624
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Diabetes Coaching Program for Medicare Advantage Members with Type 2 Diabetes - Impact on A1c trial is a 26-week long, prospective, intent-to-treat, 2-arm randomized controlled trial that aims to evaluate the impact of the Digital Health Partnership on A1c levels for individuals with uncontrolled Type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Humana Medicare Advantage member
* Type 2 diabetes diagnosis
* HbA1c levels ≥ 8.0% verified by lab test

Exclusion Criteria:

* Has any of the following conditions: cancer, chronic heart failure, chronic obstructive pulmonary disease, respiratory failure, chronic kidney disease, end stage renal disease, peripheral vascular disease
* Not fluent in English
* Humana membership is part of a Full or Global risk arrangement
* Enrolled in Humana at Home Care Management

Primary outcomes:
measure: A1c
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Mateo
country: United States
facility: Evidation Health
state: California
Study officials:
References:
Clinical trial NCT05073900: Comparison of the Efficacy of Rhomboid Intercostal Block and Erector Spinal Plane Block on Myofascial Pain Syndrome
Official title: Comparison of the Efficacy of Ultrasound Guided Rhomboid Intercostal Block and Erector Spinal Plane Block on Lower Cervical and Interscapular Myofascial Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The investigators evaluate the effect of Ultrasound guided Rhomboid Intercostal Block and Erector Spinal Plane Block on lower cervical and inter scapular Myofascial Pain

Detailed description: Myofascial pain syndrome (MPS) is the most common cause of musculoskeletal pain and its prevalence in the population is reported to be 21-30%. In this study, the investigators compare the effect of two regional anesthesia block techniques with the ultrasound guidance.

Eligibility criteria: Inclusion Criteria:

* Complaint of myofascial pain
* Pain that is rated at least 3 on a numerical rating scale (NRS, 0 = no pain, 10 = the worst pain)

Exclusion Criteria:

* pregnancy
* presence of coagulopathy, or the use of anticoagulants
* a history of surgery on the block area
* allergic to bupivacaine
* decline to participate

Primary outcomes:
measure: Numerical Rating Scale (NRS)
timeFrame: Change from baseline to minutes 30, day 1, week 1, 2, 4, 6 after the block
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazit Training and Research Hospital
Study officials:
affiliation: Diskapi Teaching and Research Hospital
name: selin guven kose
role: PRINCIPAL_INVESTIGATOR
References: