louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06188221: Does Adding Lidocaine to Corticosteroid Injections Reduce Pain Intensity in Hand Surgery
Official title: Does Adding Lidocaine to Corticosteroid Injections Reduce Pain Intensity in Hand Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Osteoarthritis
Trigger Finger
Carpal Tunnel Syndrome
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized in two groups for the corticosteroid injection, one group with lidocaine and one group without lidocaine.
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine whether adding Lidocaine to Corticosteroid injections reduce pain intensity in hand surgery.

Detailed description: There is a lack of evidence about the use of lidocaine injection as an addition to steroids against pain during injections. Adding lidocaine adds to the volume of the injection, which might increase pain. It's possible that injecting cortisone without any lidocaine would be more comfortable than with lidocaine.

The aim of this randomized controlled trial is to assess the difference in pain intensity (during the injection and 4 hours later) between patients receiving a corticosteroid injection with or without lidocaine in patients with a hand condition. Secondarily, the aim of this study is to assess factors independently associated with pain intensity, satisfaction with the visit, and perceived empathy.

Eligibility criteria: Inclusion Criteria:

* All patients offered a steroid injection in a hand surgeon's office
* Aged 18-89 years
* English speaking patients
* Able to provide informed consent

Exclusion criteria:

* Non-English/Spanish speakers

Primary outcomes:
measure: Pain intensity during injection
timeFrame: During Injection
measure: Pain Catastrophizing Scale (PCS 4)
timeFrame: through study completion, an average of 6 weeks
measure: Patient Health Questionnaire (PHQ 2)
timeFrame: through study completion, an average of 6 weeks
measure: Pain Self-efficacy Questionnaire (PSEQ 2)
timeFrame: through study completion, an average of 6 weeks
Secondary outcomes:
measure: Pain intensity 4 hours after injection
timeFrame: 4 hours after injection
measure: Pain intensity 5 minutes after injection
timeFrame: 5 minutes after injection
Other outcomes:
measure: Jefferson scale of patient perception of physician empathy
timeFrame: through study completion, an average of 6 weeks
Locations:
city: Austin
country: United States
facility: University of Texas Health Austin (UTHA)
state: Texas
Study officials:
affiliation: UT Health Austin
name: David Ring, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04412421: Supplementation After Bariatric Surgery
Official title: Adherence to Vitamin and Mineral Supplementation After Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bariatric Surgery
Micronutrient Deficiencies
Obesity
Keywords: Bariatric Surgery (Gastric Bypass, Gastric Sleeve)
Micronutrient Deficiencies
Adherence, Medication
Lead sponsor: Region Östergötland
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients subjected to bariatric surgery at Vrinnevi Hospital

Brief summary: The aim of this study is to assess medication adherence to vitamin and mineral supplements after bariatric surgery and identify factors that may influence adherence. All study participants are prescribed life-long treatment with daily oral vitamin B12 and Calcium/Vitamin-D. Menstruating women are also prescribed daily oral iron supplementation. Post-operative adherence rate is retrieved from Pharmacy refill data, collected from the Swedish Prescribed Drug Register, the five first years after bariatric surgery.

Detailed description: The aim of this study is to assess medication adherence to vitamin- and mineral supplementation after bariatric surgery, identify factors that may influence adherence, as well as study the development of micronutrient deficinencies detectable by blood sampling.

All study participants are prescribed life-long treatment with daily oral vitamin B12 and Calcium/Vitamin-D. Menstruating women are also prescribed daily oral iron supplementation.

Post-operative adherence rate is retrieved from pharmacy refill data, collected from The Swedish Prescribed Drug Register, at one, two and five years after bariatric surgery.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* Patients subjected to bariatric surgery at Vrinnevi Hospital, Norrköping, Sweden

Exclusion Criteria:

* Unable to read and understand Swedish

Primary outcomes:
measure: Adherence to vitamin and mineral supplementation
timeFrame: 5 years
measure: Time to initiation
timeFrame: 1 year
measure: Time to discontinuation
timeFrame: 5 years
Secondary outcomes:
measure: Self reported Adherence to vitamin-and mineral supplementation
timeFrame: 5 years
measure: Hemoglobin (Hb)
timeFrame: 5 years
measure: Iron status
timeFrame: 5 years
measure: s-folate
timeFrame: 5 years
measure: p-calcium
timeFrame: 5 years
measure: s-albumin
timeFrame: 5 years
measure: s-cobolamin
timeFrame: 5 years
Other outcomes:
Locations:
city: Norrkoping
country: Sweden
facility: Department of Surgery, Vrinnevi Hospital
Study officials:
affiliation: Region Östergötland
name: Ellen Andersson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06769321: Automatic Thermomechanical Massage Bed for Acute Pain Relief for Chronic Nonspecific Low Back Pain
Official title: Phase 2 RCT Automatic Thermomechanical Massage Bed for Acute Pain Relief for Chronic Nonspecific Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Non-specific Low Back Pain
Keywords: Chronic Pain
Low back Pain
Automatic Thermo-mechanical Therapy
Lead sponsor: The City College of New York
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This a double-blind sham-controlled randomized trial.
Primary purpose: TREATMENT

Brief summary: This prospective, double-blinded, sham-control, parallel-arm, randomized pilot trial will recruit n=40 participants, ages 18-65 (inclusive), with chronic low back pain (LBP) in the lower region, to be randomly assigned using 1:1 randomization method to receive a 40-minute single session of either active or sham Automated Thermo-mechanical Therapy (ATT). All research procedures, including informed consent, ATT session, and pre- and post-ATT assessments, will be completed in one single session.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 65
* Has had chronic non-specific lower back pain persisting for 12 weeks or more
* Conversational level of English

Exclusion Criteria:

* Contraindications to mechanical manipulation of the back
* History of back surgery within the past three years
* Recent back injury
* Presence of back implants or active implanted devices
* Low back pain resulting from other specific conditions (e.g., infection, neoplasm)
* Sensitivity to heat
* Circulatory insufficiency
* Heart disease
* Pregnant or breastfeeding
* Individuals with a history of substance use disorder
* Body weight over 298 lbs (135 kg)

Primary outcomes:
measure: The 100mm Visual Analogue Scale for Pain
timeFrame: Immediately before and immediately after intervention
Secondary outcomes:
measure: Roland-Morris Disability Questionnaire
timeFrame: Immediately before intervention
measure: McGill Pain Questionnaire
timeFrame: Immediately before intervention and immediately after intervention
measure: State-Trait Anxiety Inventory
timeFrame: Immediately before and immediately after intervention
measure: 5-point Verbal Rating Scale for Pain Relief
timeFrame: Immediately after intervention
measure: Modified-Modified Schöber Test
timeFrame: Immediately before and immediately after intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: The Center for Discovery and Innovation
state: New York
Study officials:
affiliation: The City College of New York
name: Marom Bikson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05946421: The BASA Study: Breath Analysis for Severe Asthma Patients
Official title: The BASA Study: Breath Analysis for Severe Asthma Patients. A New, Non-invasive Approach for the Monitoring of Inflammation in Severe Asthma Patients on Biologics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Asthma
Keywords: severe asthma
exhaled breath
biologics
monitoring
Lead sponsor: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe asthma patients eligible or already on biologic treatment that are able to follow regular visits at 2, 4, 8, 16 weeks, and to perform lung function and exhaled breath analysis.

Brief summary: This study will evaluate the fluctuations of exhaled breath markers in patients with severe asthma on biologics. In the study, severe asthma patients will be followed up to 16 weeks monitoring lung function and inflammation through non-invasive technologies such as exhaled breath analysis (FeNO, GC-MS and EBC). A control group will be followed up to two weeks with the overall objective to indentify and evaluate the modifcations of markers of inflammation in patient under biologic treatment.


Eligibility criteria: Inclusion Criteria:

* Severe asthma diagnosis according to the latest recommendation
* Eligible or in treatment with a biologic treatment for severe asthma
* Able to follow istructions
* Able and willing to sign the informed consent

Exclusion Criteria:

* Not able to perform lung function measurements and the procedures of the study
* Acute respiratory or non respiratory infection (\<4 weeks)
* Not willing to continue the study

Primary outcomes:
measure: evaluate the fluctuations of markers of inflammation in patients with severe asthma under biologic therapy
timeFrame: 16 weeks
Secondary outcomes:
measure: evaluate whether the measurement of H2O2 could be considered as a marker of inflammation in severe asthma patients
timeFrame: 16 weeks
Other outcomes:
measure: evaluate whether there are specific exhaled biomarkers useful to monitor patients with severe asthma on long-term treatment with biologics
timeFrame: 16 weeks
Locations:
city: Palermo
country: Italy
facility: AOUP Policlinico Paolo Giaccone
Study officials:
References:
Clinical trial NCT00903864: Blood Pressure Monitor Clinical Test (Cuff Range: 22 cm-30 cm)
Official title: Blood Pressure Monitor Clinical Test (Cuff Range: 22 cm-30 cm)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Lead sponsor: Andon Health Co., Ltd
Sponsor class: INDUSTRY
First posted: 2009-05-19
Enrollment: 85
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People whose arm range is 22 cm-30 cm

Brief summary: The purpose of this study is to monitor the blood pressure level of the patient using a cuff ranged 22 cm-30 cm.


Eligibility criteria: Inclusion Criteria:

* arm range: 22 cm-30 cm

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00268164: Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis
Official title: Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Chr Hansen
First posted: 2005-12-22
Enrollment: 48
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 the lactic acid bacteria " Lactobacillus acidophilus (LA5) and Bifidobacterium animalis subsp. lactis (BB12)" is effective as maintenance treatment in ulcerative colitis.


Eligibility criteria: Inclusion Criteria:

* Patients with ulerative colitis ording to well-known diagnostic criteria and remission for at least one month, and with at least one relapse within the last year.

Exclusion Criteria:

* Pregnancy and lactating
* Serious underlying disease other than UC
* Former gastrointestinal resections
* Medication for UC other than mesalazine
* Known allergic reactions towards compounds in the study drug.
* Expected lack of compliance due to mental state or language problems

Primary outcomes:
measure: Number of patients with relapse at 12 month.
Secondary outcomes:
measure: Number of days to relapse.
measure: Presence and concentrations of the probiotic bacterial strains in stool.
measure: Safety and tolerance of the probiotic mixture.
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Dept. of Medical Gastroenterology
Study officials:
affiliation: Dept. of Medical Gastroenterology, Hvidovre University Hospital, Denmark
name: Flemming Bendtsen, MD, DMSci
role: STUDY_CHAIR
References:
citation: Wildt S, Nordgaard I, Hansen U, Brockmann E, Rumessen JJ. A randomised double-blind placebo-controlled trial with Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp. lactis BB-12 for maintenance of remission in ulcerative colitis. J Crohns Colitis. 2011 Apr;5(2):115-21. doi: 10.1016/j.crohns.2010.11.004. Epub 2011 Jan 8.
Clinical trial NCT00004564: The Inhibition of Platelet Antiaggregating Activity of Clopidogrel by Atorvastatin Detected by Erythromycin Breath Test: a Metabolic Inhibition of Hepatic Cytochrome P450-3A
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypercholesterolemia
Thrombosis
Keywords: Platelet Aggregation Inhibitors
Cerebrovascular accident
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-02-14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine if the action of the drug called clopidogrel, that you will start taking, will be decreased by another drug called atorvastatin, that you will also start taking. Clopidogrel is an oral antiplatelet agent that has been shown to prevent strokes and heart attacks. Atorvastatin is a cholesterol lowering agent.

Twenty adults 18-75 years of age requiring cholesterol-lowering agent and antiplatelet agent therapy will be recruited for this study during their cardiology clinic visitation. In one group, antiplatelet agent (clopidogrel) regimen will be administered first, then followed by cholesterol-lowering medication (atorvastatin). In the second group, atorvastatin will be administered first, followed by clopidogrel.

A new test called the erythromycin breath test will be administered to you three times during the study to measure how your liver will metabolize these drugs. Blood samples will also be obtained to assess platelet function. The criteria for exclusion are patient refusal or inability to give written consent, patients with allergic reaction to erythromycin, patients with known bleeding problems, liver disease, significant lung disease kidney disease and pregnancy. Patients with psychiatric impairment and documented history of substance abuse will also be excluded from the study.


Eligibility criteria: Inclusion Criteria:

* Males and females age 18-75 years of age without bias in racial and ethnic background, undergoing percutaneous coronary intervention requiring antiplatelet therapy: 1. Patients presented to cardiology clinic requiring cholesterol lowering agent 2. Patients presented to cardiology clinic requiring antiplatelet agent.

Exclusion Criteria:

* Refusal or inability to give written consent
* Allergic reaction to erythromycin
* Have known bleeding problems, liver disease, significant lung disease kidney disease
* Pregnancy
* Psychiatric impairment and documented history of substance abuse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: 1G323 University Hospital, Box 0048 1500 E Medical Center Drive
state: Michigan
Study officials:
References:
Clinical trial NCT00287664: Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin
Official title: Terlipressin as Treatment of Patients With Cirrhosis and Hepatorenal Syndrome. Effect on Survival and Renal Function. Multicenter, Randomized and Prospective Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Cirrhosis
Hepatorenal Syndrome
Keywords: hepatorenal syndrome
terlipressin
albumin
cirrhosis
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Grant from Education Ministery from 2001-2004.
First posted: 2006-02-07
Enrollment: 100
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: Hepatorenal syndrome is a common complication of cirrhotic patients. The prognosis of patients with HRS is very poor. It have been demonstrated that vasoconstrictors agents (Terlipressin) plus albumin are effective in the reversal of the treatment. However, previous studies are pilot studies and they are not able to give information about an improvement in survival. This comparative randomized study was delineated to test the efficacy of terlipressin on survival.

Detailed description: Phase 3

Eligibility criteria: Inclusion Criteria:

1. Patients with HRS type 1 or 2 with serum creatinine \>2 mg/dL
2. Age between 18 and 75 years
3. Written informed consent.
4. Absence of exclusion criteria

Exclusion Criteria:

1. Hepatocarcinoma (3 nodules greater than 3 cm or 1 nodule \> than 5 cm)
2. Active infection with systemic inflammatory response syndrome
3. Respiratory or cardiac dysfunction.
4. Arteriopathy.
5. Ischemic cardiopathy.
6. Arterial hypertension ( \>140/90 mmHg during hospitalization )

Primary outcomes:
measure: Survival
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
affiliation: Chair of Liver Unit
name: Pere Gines, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005464: DISH Data Analysis Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To perform extensive analyses of data from the Dietary Intervention Study of Hypertension (DISH)..

Detailed description: BACKGROUND:

DISH was a multicenter, controlled, randomized study conducted in 1980-1983 of 496 patients, who were formerly participants in the Hypertension Detection and Follow-up Program and who had their blood pressure well controlled with medication. At DISH baseline they were randomized to continue medication or to be withdrawn from antihypertensive medication to determine if weight reduction or sodium restriction/potassium increase interventions could maintain these people under blood pressure control without drugs. Only the main findings regarding diastolic blood pressure control under the different diet regimens, were analyzed and reported during the course of DISH funding. Many questions which could be uniquely addressed by this comprehensive data base remained unexplored.

DESIGN NARRATIVE:

The investigators explored the questions dealing with demographic, clinical and physiologic predictors of relapse to the hypertensive state. They also analyzed the mortality experience of this cohort five years post DISH in relation to the DISH randomization groups and in relation to success in remaining off drugs during DISH. They did this by querying the National Death Index to determine who of the DISH participants died following the termination of DISH.

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: Thaler L, Wassertheil-Smoller S, Blaufox MD, Oberman A, Langford HG. Effect of withdrawal of antihypertensive drug on depressive mood. Am J Hypertens. 1993 Dec;6(12):1055-62. doi: 10.1093/ajh/6.12.1055.
citation: Ho GY, Blaufox MD, Wassertheil-Smoller S, Oberman A, Langford H. Plasma renin predicts success of antihypertensive drug withdrawal. Am J Hypertens. 1994 Aug;7(8):679-84. doi: 10.1093/ajh/7.8.679.