louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02658773: Lidocaine-prilocaine Cream on IUD Insertion Pain
Official title: Effect of Cervical Lidocaine-prilocaine Cream on IUD Insertion Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: IUD Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the investigators' study was to evaluate whether cervical lidocaine-Prilocaine cream will improve pain scores compared to placebo. The investigators hypothesized that lidocaine-Prilocaine cream will reduce the insertion pain.

Detailed description: IUD can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the IUD insertion tube, and removing the tube; and placement of the device in the uterus.

To minimize the discomfort and the hazards of an IUD insertion, several measures have been proposed including NSAIDs, anxiolytics, and local anesthetics in the form of intracervical gel, cervical and para-cervical block, but there have not done enough studies about their effectiveness. According to the review published in the Cochrane, non-steroidal anti-inflammatory drugs and misoprostol are not effective on reducing an IUD insertion pain. Many trials have been done about effectiveness of lidocaine gel in reducing pain during IUD insertion and only one of those trials showed positive effect of 2% lidocaine gel, while others failed.

Lidocaine 2.5% and Prilocaine 2.5% Cream, is an emulsion in which the oil phase is a eutectic mixture of Lidocaine and Prilocaine cream in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as liquid oil rather than as crystals. Its absorption of from the genital mucosa is more rapid and onset time is shorter (5 to 10 minutes) than after application to intact skin. After a 5 to 10 minute application of Lidocaine-Prilocaine cream to female genital mucosa, the average duration of effective analgesia was 15 to 20 minutes.

Eligibility criteria: Inclusion Criteria:

* Women not taken analgesics or anxiolytics in the 24 hours prior insertion
* Women not taken misoprostol prior to IUD insertion
* No contraindication to or history of allergic reaction to lidocaine
* Women who will accept to participate in the study

Exclusion Criteria:

* Lidocaine allergy
* Any contraindication to IUD placement

Primary outcomes:
measure: Mean pain score during IUD insertion
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT04535973: Hormonal Status and Quality of Life in Female Postmenopausal Patients With Burning Mouth Syndrome
Official title: Hormonal Status and Quality of Life in Female Postmenopausal Patients With Burning Mouth Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burning Mouth Syndrome
Progesterone
Dehydroepiandrosterone
Quality of Life
Hormone Disturbance
17β-Estradiol
Keywords: burning mouth syndrome
hormonal status
quality of life
Lead sponsor: University of Zagreb
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 40
Sex: FEMALE
Minimum age (years): 51
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: postmenopausal women are most frequently affected with burning mouth syndrome, and we wanted the groups to be as similar as possible so we included only postmenopausal women, with and without burning mouth syndrome

Brief summary: The aim of this study was to determine the level of salivary estradiol, progesterone and dehydroepiandrosterone in female postmenopausal women with and without burning mouth syndrome. In all participants the quantity of unstimulated and stimulated saliva would be determined and they would fulfill self-perceived quality of life questionnaire Oral Health Impact Profile-14 (OHIP-14). Intensity of burning symptoms would be determined on visual-analogue scale grading 0-10. All data would be compared between study and control group.


Eligibility criteria: Inclusion Criteria:

* postmenopausal women with burning mouth syndrome

Exclusion Criteria:

* women with burning mouth syndrome who are not in menopause

Primary outcomes:
measure: to evaluate the levels of salivary hormone
timeFrame: November 2019-June 2020
Secondary outcomes:
measure: to evaluate quality of life and correlate it with levels of salivary hormones and intensity of symptoms
timeFrame: November 2019-June 2020
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: School of Dental Medicine, University of Zagreb
Study officials:
References:
Clinical trial NCT03711773: Outcomes of Low-Impact Exercise Program for People with Ankle, Knee, And/or Hip Pain
Official title: Outcomes of Low-Impact Group Exercise Program for People with Ankle, Knee, And/or Hip Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Osteoarthritis Ankle
Keywords: joint pain
osteoarthritis
hip pain
knee pain
ankle pain
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 10000
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: The primary objective of this study is to study how low-impact group exercise classes affect pain scores in patients with knee, hip, and ankle pain when paired with concurrent standard of care dietitian and behavioral health consults.

Detailed description: Osteoarthritis is estimated to affect at least 10% of men and 13% of women over 60 years old in the United States. It's estimated roughly 1 million total joint replacements are being performed each year. Studies have suggested that for patients with knee pain that have high BMIs, low strength, and/or have not participated in conservative measures, a low-impact exercise plan when paired with diet counseling and behavioral health classes can improve patient reported outcomes scores in both pain and function. This study seeks to build upon this research and will provide low-impact exercise plans that will be paired with standard of care dietician and behavioral health interventions in order to offer patients a full-scope approach to battling osteoarthritis pain, especially for those with high BMIs, low strength, and/or for patients that have not attempted conservative therapy in the past. We will include patients with knee, hip, and ankle pain.

Eligibility criteria: Inclusion Criteria:

* 18 and over
* Ability to attend classes 3x weekly for 6 months with at least a 66% attendance rate
* Ability to concurrently attend standard of care dietitian and behavioral health classes for 6 months
* Joint pain (knee, ankle, hip)

Exclusion Criteria:

* Pregnant
* Prisoners

Primary outcomes:
measure: VAS Pain scores
timeFrame: 6 Months
Secondary outcomes:
measure: BMI
timeFrame: 6 Months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Missouri Orthopaedic Institute
state: Missouri
Study officials:
References:
Clinical trial NCT00933673: New Combination Regimen of L-asparaginase, Dexamethasone, Ifosfamide, Cisplatin and Etoposide in NK/T-Cell Lymphoma
Official title: Phase II Study of L-asparaginase Plus DICE Regimen in Patients With Stage I/II NK/T-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoma
Keywords: NK/T cell lymphoma
DICE
L-asparaginase
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2009-07-07
Enrollment: 76
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and tolerability of the combination chemotherapy of L-asparaginase plus DICE regimen in the patients with early stage NK/T-cell lymphoma.

Detailed description: DICE regimen was found to be highly effective as induction chemotherapy in patients with early stage NK/T-cell lymphoma in the ongoing study. L-asparaginase, an agent with unique anti-cancer mechanism, was also found to be effective in salvage setting. In terms of non-overlapped efficacy and toxicity, the investigators designed this phase II study to verify the efficacy and tolerability of this new combination.

Eligibility criteria: Inclusion Criteria:

* Age range 14-75 years old
* Histological confirmed, previously untreated stage I/II NK/T cell lymphoma in the upper-aerodigestive tract
* ECOG performance status less than 2
* Life expectancy of more than 3 months
* Normal laboratory values: hemoglobin \> 80 g/dl, neutrophil \> 2×109/L, platelet \> 100×109/L, serum creatine \< 1.5×upper limitation of normal (ULN), serum bilirubin \< 1.5×ULN, ALT and AST \< 2.5×ULN

Exclusion Criteria:

* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection
* The evidence of CNS metastasis
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

Primary outcomes:
measure: complete response rate
timeFrame: 6 weeks
Secondary outcomes:
measure: Overall response rate, PFS and OS
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Ye Guo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00850473: PET/CT Study in the Diagnosis of Coronary Plaque
Official title: Comparison of Cardiac Positron Emission Tomography/Computed Tomography (PET/CT) With Coronary Angiography (CA) and Intravascular Ultrasound (IVUS) in the Diagnosis and Characterization of Coronary Artery Plaque
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Myocardial Infarction
Coronary Artery Disease
Cardiac Catheterization
Keywords: PET
CT
Heart Attack
Coronary Artery disease
Cardiac Catheterization
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2009-02-25
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is being done to determine if a picture taking test of the heart, positron emission tomography/computed tomography (or cardiac PET/CT), can identify the blockages in the heart arteries that lead to heart attacks when compared to the standard of heart catheterization.

Detailed description: Heart catheterization, in which a thin plastic tube, or catheter, is placed into an artery in the arm or leg and advanced into the heart arteries, is the procedure that you and your doctor have decided to pursue to look for heart artery blockages. It is being performed as part of your standard care and not for research purposes. The research procedure (cardiac PET/CT), which will be performed at a later date is a combination of heart CT (a test that involves the use of x-rays to identify heart artery blockages) and heart PET (an imaging test that uses a radioactive drug to look at how the heart uses fuel (sugar and fats) These tests will be combined (PET/CT) to look for the presence and type of blockage in your heart arteries.

It is important to develop a test that can determine if and what type of blockage you have in your heart arteries as the presence and type of heart artery blockage is a very important predictor of heart attack and death from heart attack.

Eligibility criteria: Inclusion Criteria:

* 18 years oof age or older
* referred for cardiac catheterization.
* coronary artery disease that does not need angioplasty.

Exclusion Criteria:

* history of cardiac stents
* bypass surgery
* bad kidney function
* unable to take beta blocker medication
* history of asthma
* allergies to egg containing products
* atrial fibrillation
* pregnancy
* breastfeeding
* overweight by definition of a BMI over 35.

Primary outcomes:
measure: Number of Participants With Clear Anatomical Landmarks Confirmed by CT
timeFrame: During PET CT scan, an average of 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Cardiovascular Imaging Laboratory
state: Missouri
Study officials:
affiliation: Washington University in St. Louis Physicians
name: Peter Rao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01557127: Nexavar Dosing in Renal Cancer Patients in "Real-life" Setting
Official title: Nexavar Dose Evaluation Study in Patients With Advanced Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Renal Cell
Keywords: Renal cell carcinoma,
Sorafenib
Dosing
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-03-19
Enrollment: 205
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: Adult patients with renal cell carcinoma scheduled to treatment with sorafenib, following therapy failure with IFN/IL-2

Brief summary: This study is a registry of renal cancer patients treated with Nexavar. It aims to evaluate the actual dosing of Nexavar in "real-life" setting vs. the prescribed dose.


Eligibility criteria: Inclusion Criteria:

* Age \>/= 18 years
* Diagnosis of renal cell carcinoma
* Failure of prior therapy with interferon-alfa (IFN) or interleukine-2 (IL-2) or disqualified from therapy with IFN/IL-2
* Patients in whom the oncologist has decide to start therapy with sorafenib.

Exclusion Criteria:

* Synonymous with contraindications to Nexavar.

Primary outcomes:
measure: Percentage of patients in whom the actual dose of sorafenib equaled the planned dose
timeFrame: 12 months
Secondary outcomes:
measure: Overall tolerability of treatment as measured by rate of adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Many Locations
country: Poland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05916027: Identification and Treatment of Alcohol Problems in Primary Care
Official title: iTAPP Study - Identification and Treatment of Alcohol Problems in Primary Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol Abuse Alcoholism
General Practice
Screening and Brief Intervention
Keywords: Primary Care
Screening
Alcohol Use Disorder
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped-wedge cluster randomized controlled trial.
Primary purpose: SCREENING

Brief summary: The Identification and Treatment of Alcohol Problems in Primary Care (iTAPP) Study is a pragmatic cluster randomized controlled intervention trial evaluating the effectiveness of the 15-Method as an identification and treatment tool for alcohol-related problems in Danish general practice. The 15-Method combines evidence-based approaches from specialized addiction treatment with screening and readily available treatment options in general practice to help identify and treat alcohol problems in a primary care setting. The method has shown promising results as a treatment tool in Sweden. A feasibility study of the 15-Method in Denmark suggested that the method can be implemented in Danish general practice.

The trial is led by the Unit for Clinical Alcohol Research at The University of Southern Denmark in collaboration with The Research Unit of General Practice Odense at The University of Southern Denmark.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Affiliated with the participating general practices

Exclusion Criteria:

- None

Primary outcomes:
measure: Frequency of alcohol related conversations in the clinics
timeFrame: Up to 19 months
Secondary outcomes:
measure: Percentage of patients who exceed the Danish national recommendations of alcohol consumption
timeFrame: 4 times of 10 minutes
measure: Quality of Life 5D-5L scores
timeFrame: 4 times of 10 minutes
measure: Pharmacological Treatment
timeFrame: 0-4 sessions of 15 minutes
measure: Use of blood sampling
timeFrame: 0-4 sessions of 15 minutes
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Unit for Clinical Alcohol Research, Clinical Institute, University of Southern Denmark
state: Fynen
Study officials:
affiliation: Unit of Clinical Alcohol Research, University of Southern Denmark
name: Anette S Nielsen, Professor
role: STUDY_DIRECTOR
affiliation: Research Unit of General Practice Odense, University of Southern Denmark
name: Jens Søgaard, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scholer PN, Volke KH, Andreasson S, Rasmussen S, Sondergaard J, Nielsen AS. The identification and treatment of alcohol problems in primary care (iTAPP) study: protocol for a stepped wedge cluster randomized control trial testing the 15-method in a primary care setting. Addict Sci Clin Pract. 2024 Jun 13;19(1):49. doi: 10.1186/s13722-024-00474-6.
Clinical trial NCT01016327: Study of NMS-1116354 in Solid Tumors
Official title: A Phase I Dose-Escalation Study of NMS-1116354 in Adult Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Phase I study
Advanced Solid Tumors
Cdc7 kinase inhibitor
Lead sponsor: Nerviano Medical Sciences
Sponsor class: INDUSTRY
First posted: 2009-11-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety profile of NMS-1116354, a CDC7 kinase inhibitor, in adult patients with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

1. Advanced/metastatic solid tumors, for which no alternative effective standard therapy is available
2. Maximum of 4 regimens of prior cancer therapy allowed
3. Prior radiotherapy allowed if no more than 25% of BM reserve irradiated
4. Resolution of all acute toxic effects (excluding alopecia) of any prior anticancer therapy
5. ECOG performance status (PS) 0 or 1
6. Adult (age \>/= 18 and \</= 80 years) patients
7. Adequate renal, liver and BM reserve
8. Capability to swallow capsules intact

Exclusion Criteria:

1. Current enrollment in another therapeutic clinical trial
2. Known brain metastases
3. Currently active second malignancy
4. Major surgery within 4 weeks prior to treatment
5. Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
6. Pregnancy or breast-feeding women
7. Known active infections
8. Gastrointestinal disease or other malabsorption syndromes that would impact on drug absorption
9. Adrenal insufficiency
10. Other severe acute or chronic medical or psychiatric condition that could compromise protocol objectives

Primary outcomes:
measure: First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose (MTD)
timeFrame: Cycle 1
Secondary outcomes:
measure: Evaluation of pharmacokinetics: plasma concentration at different times after dosing, area under the curve (AUC), maximum plasma concentration (Cmax), time of occurence of Cmax (tmax) and half-life (t½)
timeFrame: Cycles 1 and 2
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics (START)
state: Texas
Study officials:
affiliation: South Texas Accelerated Research Therapeutics (START)
name: Kyriakos Papadopoulos, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Nerviano Medical Sciences
name: Bernard Laffranchi, MD
role: STUDY_DIRECTOR
affiliation: Nerviano Medical Sciences
name: Stefania Crippa, Biotech D, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06940427: Development of FAPI PET as a Non-invasive Biomarker of Pulmonary Fibrogenesis
Official title: Development of FAPI PET as a Non-invasive Biomarker of Pulmonary Fibrogenesis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Fibrosis Lung
Keywords: lung disease associated with fibrosis
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Groups A and B will be parallel; however, Group B participants will have the option to crossover to Group A upon completing Group B participation.
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to gain more information about how fibroblast activation protein inhibitor (FAPI) binds to a certain type of cells in fibrotic lung tissue and how this information can be used to better diagnose and track fibrotic lung disease activity.

Participants will undergo up to 4 PET/MRI scans using the FAPI radiotracer.

Detailed description: Researchers aim to develop a non-invasive PET/MRI imaging tool using FAPI as a PET radiotracer and MRI to assess the presence and extent of fibrogenesis (the process that leads to fibrosis and scarring) in the lungs.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Able and willing to provide informed consent
* Clinically evaluated for need for initiation of new treatment (in patients not on current treatment), initiation of change in current treatment, or addition of new treatment (to any current treatment) in the setting of fibrotic hypersensitivity pneumonitis (HSP) or idiopathic pulmonary fibrosis (IPF), per standard of clinical care at UW Health.
* Willing and able to undergo PET/MRI.
* Participants requiring intravenous (IV) conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:

  * The subject has their own prescription for the medication
  * Informed consent is obtained prior to the self-administration of this medication
  * They come to the research visit with a driver

Exclusion Criteria:

* Participant is unable or unwilling to provide informed consent
* Participant is pregnant
* Participant with contraindication(s) to or inability to undergo PET/MRI
* Participants with contraindications to GBCA will be asked to undergo research imaging without the use of contrast. Contraindications may be severe kidney disease or previously documented GFR \< 30 ml/min/1.73 m2

Primary outcomes:
measure: Change in FAPI uptake
timeFrame: Baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ali Pirasteh, MD
role: PRINCIPAL_INVESTIGATOR
References: