louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05062499: The Effects of Home Use of Transcutaneous Electrical Nerve Stimulation on People With Knee OA and or Chronic Knee Pain
Official title: The Effects of Home Use of Transcutaneous Electrical Nerve Stimulation on People With Knee Osteoarthritis (OA) and or Chronic Knee Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Pain Chronic
Knee Osteoarthritis
Lead sponsor: Omron Healthcare Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Western Michigan University
First posted: 2021-09-30
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the research is to see if the use of transcutaneous electrical nerve stimulation (TENS) at home would reduce knee pain and swelling in people with knee OA and/or chronic knee pain.


Eligibility criteria: Inclusion Criteria:

* The inclusionary criteria for subjects: Male or Female with the age of 45 years or older, ultrasonography scale of 0-3 for grading of primary Knee OA of the knees, pain perceived as a minimum of 3/10 and a maximum of 7/10 weekly average during the baseline period on a 0-10 active VAS pain scale, no phobia of electrical stimulation, no pain or anti-inflammatory medication will be taken during the study. Injury/pain that began at the knee a minimum of 6-weeks before entering the study.

Exclusion Criteria:

* Exclusion criteria for the subjects: Pregnancy, Diabetes Mellitus, Neuropathy, Smoker, Uncontrolled HTN, Past surgery in the region to be treated by TENS or had received an intra-articular corticosteroid or hyaluronic acid injection within 6 months before enrollment, Arthritis (RA) in the area to be treated by TENS, Allergic to tape/electrodes, Dementia, history of knee joint replacement or tibial osteotomy, undergoing physical therapy, any other major joint pain (e.g., back, hip, or ankle) that could limit functional ability, contraindications to TENS (pacemakers, dermatological conditions, and abnormal sensation in the knees), severe medical or neurological conditions (e.g. Chronic obstructive pulmonary disease, cardiovascular disease, arteriosclerosis obliterans, cerebrovascular accident, lumbar disc, herniation, and rheumatoid arthritis) or do not utilize stairs in daily living and unable to walk without ambulatory assistive devices. The candidate will be disqualified as a subject for the study if less than 5 days of pedometer use or less than 5 days VAS reporting within the prior week's baseline period.

Primary outcomes:
measure: Knee pain evaluated using the VAS for the stair climb test.
timeFrame: 10min
measure: 6-minute walk test (6MWT)
timeFrame: 15min
measure: Timed Up and Go (TUG) test
timeFrame: 10min
Secondary outcomes:
measure: knee extensor strength
timeFrame: 10min
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06300099: Dexamethasone Versus Dexmedetomidine as Adjuncts to Serratus Anterior Plane Block
Official title: Dexamethasone Versus Dexmedetomidine as Adjuncts to Serratus Anterior Plane Block for Postoperative Analgesia After Modified Radical Mastectomy A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Breast Cancer
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 126
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Modified radical mastectomy is the most commonly performed surgical approach for breast cancer. The procedure enables surgeons to remove the main tumor mass, adjacent glandular tissue and regional lymph nodes. Moreover, it provides a cosmetic outcome that clearly surpasses the standard radical mastectomy and allows subsequent breast reconstruction with favorable results.

The present randomized study aims to compare the postoperative analgesic effects of dexamethasone and dexmedetomidine as adjuncts to serratus anterior plane block in women undergoing modified radical mastectomy.

Detailed description: Modified radical mastectomy is the most commonly performed surgical approach for breast cancer. The procedure enables surgeons to remove the main tumor mass, adjacent glandular tissue and regional lymph nodes. Moreover, it provides a cosmetic outcome that clearly surpasses the standard radical mastectomy and allows subsequent breast reconstruction with favorable results.

Serratus anterior plane block (SAPB) with ultrasound guidance is a fascial plane block that proved to be feasible, safe and effective tool for reduction of postoperative pain after thoracic and breast surgeries. In multiple instances, SAPB is used with additional adjuncts e.g. dexamethasone or dexmedetomidine to improve analgesic potency and duration.

Eligibility criteria: Inclusion Criteria:

Consecutive American Society of Anesthesiologists (ASA) class I-II female patients with breast cancer indicated for modified radical mastectomy

Exclusion Criteria:

Allergy to the study medications . Patients will also be excluded if they have history of chronic pain conditions, opioid dependence or if they received prolonged analgesic therapy prior to surgery.

Primary outcomes:
measure: postoperative visual assessment scale for pain.
timeFrame: 72 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06761599: Frequency of Pulmonary Toxicity in Patients Treated for Hodgkin Lymphoma
Official title: Frequency of Pulmonary Toxicity in Patients Treated for Hodgkin Lymphoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hodgkin Lymphoma
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: to check the Frequency of Pulmonary Toxicity in Patients Treated for Hodgkin Lymphoma

Brief summary: Pulmonary toxicity during Hodgkin lymphoma treatment is significant for a variety of reasons, ranging from clinical care to therapeutic innovation and patient outcomes.

Detailed description: Understanding chemotherapy-induced pulmonary issues, particularly bleomycin-induced toxicity, might enhance treatment efficacy, side effects, and quality of life for Hodgkin lymphoma patients. For Hodgkin lymphoma chemotherapy patients with pulmonary difficulties, which result in significant patient morbidity and mortality, early detection, proactive surveillance, and rapid management are required. Identifying the prevalence, risk factors, and clinical signs of pulmonary toxicity helps clinicians stratify treatment.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Hodgkin lymphoma (HL) receiving treatment.
* Patients of all ages and both genders.
* Patients with histologically confirmed HL, as per the WHO 2016 classification.
* Patients who have undergone pulmonary function testing and assessment at specified time points during their treatment course.
* Patients with complete medical records documenting treatment regimens, including chemotherapy and radiotherapy details.

Exclusion Criteria:

* Patients with a diagnosis of another malignancy.
* Patients with incomplete medical records or missing data on treatment regimens and pulmonary function assessments.
* Patients with a history of significant pulmonary comorbidities, such as chronic obstructive pulmonary disease (COPD), interstitial lung disease, or pulmonary fibrosis, before HL diagnosis.
* Patients who are unable to complete pulmonary function tests.

Primary outcomes:
measure: high-resolution computed tomography
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Shaukat Khanum Memorial Cancer Hospital and Research Centre, 5-B, Sector A2, Phase 5, Hayatabad
state: Khyber Pakhtunkhwa
Study officials:
References:
Clinical trial NCT02211599: Fat Burning After a Meal
Official title: Post-Prandial Substrate Utilization in Response to the Inclusion of Sweetened Beverage to Meals With Different Levels of Protein Content
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Effect of Carbohydrate Beverage Consumption
Keywords: protein
carbohydrate
lipid
oxidation
fat
sugar
juice
obesity
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2014-08-07
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of the study is to determine how adding a carbohydrate beverage to a meal with different protein levels affects the rate at which one's body burns fats, sugars, and proteins.


Eligibility criteria: Inclusion Criteria:

* BMI less than 25 kg/m2
* ability to sign the consent form
* availability of transportation

Exclusion Criteria:

* percent body fat greater than or equal to 25% for males and 35% for females
* allergies to any study foods
* more than a 10% change in body weight within the past 2 months
* current or planned pregnancy
* lactation
* metabolic illness/disease(s)
* active cancer or in short-term remission (less than 3 years)
* infectious diseases
* alcohol or drug abuse
* tobacco use
* presence of acute illness
* taking medications known to affect energy expenditure and appetite

Primary outcomes:
measure: Postprandial lipid oxidation rate
timeFrame: 4 hours after meal consumption
Secondary outcomes:
measure: Energy expenditure measured by postprandial thermogenesis
timeFrame: 4 hours after meal consumption
measure: Postprandial protein oxidation
timeFrame: 4 hours after meal consumption
measure: Postprandial carbohydrate oxidation
timeFrame: 4 hours after meal consumption
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Shanon Casperson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: USDA Grand Forks Human Nutrition Research Center
name: James Roemmich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Casperson SL, Hall C, Roemmich JN. Postprandial energy metabolism and substrate oxidation in response to the inclusion of a sugar- or non-nutritive sweetened beverage with meals differing in protein content. BMC Nutr. 2017 Jul 21;3:49. doi: 10.1186/s40795-017-0170-2. eCollection 2017.
Clinical trial NCT01903499: Satiety Effects of Beef Compared to Beans
Official title: Satiety Effects of Beef Compared to Beans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Selection
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2013-07-19
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The satiety effects of beef will be compared to beans. Beef is hypothesized to be more satiating than beans.

Detailed description: Subjects will consume 2 different meatloaf lunches and satiety will be measured by visual analogue scales. They will consume an ad lib snack after 3 hours and food intake will be measured.

Eligibility criteria: Inclusion Criteria:

healthy, non-smoking, BMI of 18-27, non-dieting, typically consumes breakfast/lunch

Exclusion Criteria:

distaste for beans, vegetarian, current smoker, restrained eating habits, recent weight change, history of significant disease of past medical history, pregnant, lactating irregular menstrual cycle

Primary outcomes:
measure: satiety
timeFrame: 180 minutes
Secondary outcomes:
measure: food intake
timeFrame: 180 minutes
Other outcomes:
Locations:
city: St. Paul
country: United States
facility: Department of Food Science and Nutrition
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Joanne L Slavin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00612599: Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Type 2 Diabetes
Official title: Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Non-obese and Obese With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-02-11
Enrollment: 75
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 50 three times a day to biphasic insulin aspart 70 three times a day in non-obese and obese with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes for at least 12 months
* Stable glycaemic control, having been on the existing treatment for at least 1 month
* BMI between 23-28 kg/m2 (non-obese) or between 30-35 kg/m2 (obese)
* HbA1c below 9.0%
* Willing to eat three main meals per day during the trial period and perform Self-Monitoring of Blood Glucose (SBGM) regularly

Exclusion Criteria:

* A history of drug abuse or alcohol dependence
* Blood donation within the last 3 months
* Currently being treated with systemic corticosteroids, Mono Amine Oxidase (MAO) inhibitors, beta-adrenergic blocking agents, anabolic steroids or any other drug affecting blood glucose
* Severe, uncontrolled hypertension
* Proliferative retinopathy or maculopathy requiring acute treatment
* Pregnancy, breast-feeding, intention of becoming pregnant or judged not to be using adequate contraceptive measures (for women of childbearing potential only contraceptive pills and intra uterine devices are considered as adequate contraceptive methods)

Primary outcomes:
measure: Area under the serum glucose concentration profile during 24 hours
timeFrame: after 4 weeks of treatment
Secondary outcomes:
measure: Pharmacodynamics properties
measure: Pharmacokinetic properties
measure: 8-point self-monitored blood glucose profiles
measure: Adverse events
measure: Hypoglycaemic episodes
Other outcomes:
Locations:
city: Århus C
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Parkner T, Dyrskog SE, Laursen T, Chen JW, Mouritzen U, Brondsted L, Hermansen K, Lauritzen T, Christiansen JS. Obesity does not influence the unique pharmacological properties of different biphasic insulin aspart preparations in patients with type 2 diabetes. Diabetes Obes Metab. 2010 May;12(5):414-20. doi: 10.1111/j.1463-1326.2009.01178.x.
Clinical trial NCT02874599: Cohort Biomonitoring Study to Evaluate the Biocompatibilty of Resin-based Dental Materials
Official title: Cohort Biomonitoring Study to Evaluate the Biocompatibilty of Resin-based Dental Materials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Materials Testing
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2016-08-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Adult patients who require multiple dental restorations will be included in this study. Urine and saliva samples will be taken for determination of bisphenol A levels at several time points, and for analysis of the estrogenic activity using ERE-CALUX.

Also buccal cells will be taken. Next, DNA extraction will be done with a commercial kit. We will determine global alterations in DNA methylation and DNA hydroxymethylation levels using UPLC-MS/MS.


Eligibility criteria: Inclusion Criteria:

* Caucasian, adults,

Exclusion Criteria:

* acute or chronic medical condition, presence of oral inflammatory conditions during the previous 2 weeks, chronic disease requiring intake of drugs, exposure to diagnostic X-rays in the previous 2 months, smoking and consumption of alcohol

Primary outcomes:
measure: Urinary bisphenol A levels
timeFrame: 1 year
measure: Salivary bisphenol A levels
timeFrame: 1 year
measure: %DNA methylation
timeFrame: 6 months
measure: %DNA hydroxymethylation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: BIOMAT, Department of Oral Health Sciences
Study officials:
References:
Clinical trial NCT00867399: A Safety and Tolerability Study of ABT-126 in Elderly
Official title: A Multiple Dose Study of Safety, Tolerability and Pharmacokinetics of ABT-126 in Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-03-23
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to assess the safety, tolerability and pharmacokinetics of ABT-126 in elderly subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects 65 years or greater.
* Has a MMSE score of 27 or higher.

Exclusion Criteria:

* History of dementia including by not limited to Alzheimer's disease, Parkinson's disease and mult-infarct dementia.
* History of any significant neurological disease.
* Has an estimated creatinine clearance \< 30 mL/min

Primary outcomes:
measure: Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
timeFrame: Study Days -1 thru Day 28
measure: Assess the Pharmacokinetics
timeFrame: Study Days -1 thru Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 17283
state: Florida
Study officials:
References:
Clinical trial NCT02688699: Additive Hemostatic Efficacy of EndoClot After EMR or ESD in the Gastrointestinal Tract
Official title: Italian Multicenter Prospective Randomized Trial to Compare Additive Hemostatic Efficacy of EndoClot System to Prevent Bleeding After Endoscopic Mucosal Resection or Endoscopic Submucosal Dissection of Lesions in the Gastrointestinal Tract
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colonic Polyp
Colonic Neoplasms
Colonic Dysplasia
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators want to verify in a randomised trial, the effectiveness of EndoClotTM in preventing post-procedural bleeding after EMR (Endoscopic Mucosal Resection) or ESD (Endoscopic Submucosal Dissection) for sessile lesions \>20 mm in the right colon


Eligibility criteria: Inclusion Criteria:

* \>18 years old
* lesions suitable for EMR or ESD
* \> 20 mm
* site in the right colon

Exclusion Criteria:

* Severe cardiovascular pathologies
* Liver and Urinary dysfunctions
* Hematologic diseases
* Pregnancy and breast feeding
* impossible follow-up
* platelet and coagulation disorders (PLT \< 50 x 109/L, INR \> 2)
* Sensitivity or allergy to the drug

Primary outcomes:
measure: effectiveness of EndoClotTM in preventing post-procedural bleeding
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00912899: A Study of Noscapine HCl (CB3304 ) in Patients With Relapsed or Refractory Multiple Myeloma
Official title: A Phase I Open Label Study of Noscapine HCl (CB3304 ) in Patients With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Refractory Multiple Myeloma
Keywords: Refractory Multiple Myeloma
CB3304
Noscapine HCl
Multiple Myeloma
Lead sponsor: Cougar Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase 1 study to evaluate the safety and determine maximum tolerated dose, safety \& tolerability of noscapine HCl in patients with advanced multiple myeloma


Eligibility criteria: Inclusion Criteria:

* Advanced Multiple Myeloma.
* Progression after ≥ 2 lines of prior therapy, including at least one steroid, one immunomodulatory agent (iMID), one alkylator, and bortezomib (VELCADE®).
* ECOG performance status of either 0 or 1.

Exclusion Criteria:

* Prior chemotherapy with antimicrotubule agents
* Metastasis involving the brain or spinal cord
* Clinically significant lung or heart disease
* Abnormal electrocardiogram

Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.

Primary outcomes:
measure: To determine the maximum tolerated dose
timeFrame: During the first 28 day treatment cycle
Secondary outcomes:
measure: To determine the safety and tolerability in the study population
timeFrame: End of the study treatment
measure: To evaluate the pharmacokinetics of study drug
timeFrame: End of the study treatment
measure: To assess anti-tumor effects as classified by International Uniform Response Criteria for Multiple Myeloma
timeFrame: End of the study treatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: New York City
country: United States
facility: St. Vincent's Comprehensive Cancer Center
state: New York
city: New York City
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: New York City
country: United States
facility: Columbia Presbyterian Hospital
state: New York
Study officials:
References: