louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02765698: Efficacy of PET/MRI in Detecting Metastatic Disease in Endometrial Cancer
Official title: Efficacy of PET/MRI in Detecting Metastatic Disease in Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Endometrial Cancer
Keywords: Magnetic Resonance Imaging
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-05-09
Enrollment: 2
Sex: FEMALE
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: Women with biopsy-proven high risk (type 2 or grade 3 endometrioid histology) endometrial cancer undergoing debulking surgery.

Brief summary: The purpose of this study is to evaluate the ability of PET/MRI (Positron Emission Tomography/Magnetic Resonance Imaging) to give physicians preoperative information about specific sites in the body that the endometrial cancer may be present. If the PET/MRI is accurate and successful in providing this information, then women in the future may be able to have less extensive surgery for their endometrial cancer after evaluation with PET/MRI.

Detailed description: PET/MRI has recently become available at the institution and reports of its sensitivity, specificity, NPV (Negative predictive value) , PPV (Positive predictive value), and accuracy in endometrial cancer are not found in the literature to date, to the best of the investigator's knowledge. The GE PET/MRI recently obtained here at Mayo, Rochester has the potential to improve the sensitivity of detection of metastatic disease, compared to other imaging modalities, because of its superior PET technology and updated Q Clear software. For these reasons it is reasonable to expect improved sensitivity to detect metastatic disease in endometrial cancer, possibly proving PET/MRI to be a superior modality for preoperative screening and potentially allowing for less morbid surgical management for patients with high risk endometrial cancer.

Eligibility criteria: Inclusion Criteria:

* Biopsy-proven high-risk endometrial cancer (type 2 or grade 3 endometrioid histology)
* BMI of at least 18.5 kg/m2 and less than 35 kg/m2 or axial diameter less than 25 cm
* Patients who pass standard clinical MRI screening procedures
* Receiving preoperative clinical evaluation at Mayo Clinic, Rochester, MN
* Undergoing surgical staging and/or debulking at Mayo Clinic in Rochester, MN

Exclusion Criteria:

* Allergy to FDG or gadolinium
* Contraindication to MRI scanning (Extreme claustrophobia preventing PET/MRI completion, patients who are unable to lay quietly for an additional 60 minutes of imaging
* Known kidney disease or poor renal function
* Pregnant

Primary outcomes:
measure: Detection of distant metastasis of endometrial cancer by PET/MRI
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Andrea Mariani
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03946098: ICBTG in Routine Care
Official title: Implementation of Internet-based Cognitive Behavior Therapy for Problem Gambling in Routine Addiction Care: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Problem Gambling
Gambling Disorder
Keywords: Internet intervention
Gambling Disorder
Cognitive-behavioral therapy
Psychiatric comorbidity
Regular addiction care
Problem gambling
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 23
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: Problem gambling (PG) is a major public health concern worldwide. As awareness of PG has risen, treatment demand is increasing, and internet interventions is a promising alternative for providing fast, evidence-based treatment at scale, to a low cost. This article presents the protocol of an open label, uncontrolled pilot and feasibility trial of a novel internet-delivered cognitive behavioral treatment, conducted in regular addiction care with adult treatment-seeking patients (max N=25) with problematic gambling. Weekly measures of gambling symptoms and gambling will serve as outcome measures. Study results will further guide the development of the intervention and its implementation into regular addiction care.


Eligibility criteria: Inclusion criteria:

* being at least 18 years old
* living in Sweden
* being able to read and write Swedish.
* having a total score of \>= 3 on the Problem Gambling Severity Index (PGSI; Ferris \& Wynne, 2001)
* having the ability to work with online treatment material by themselves (with support from a therapist)

Exclusion criteria:

* fulfilling criteria for ongoing manic episode
* currently undergoing a parallel CBT treatment for Gambling Disorder or problem gambling.

Primary outcomes:
measure: The Gambling Symptom Assessment Scale (G-SAS)
timeFrame: Past 7 days
Secondary outcomes:
measure: The Gambling Time Line Follow Back (TLFB-G)
timeFrame: Past 7 days
measure: The 9-item Patient Health Questionnaire (PHQ-9
timeFrame: Past 2 weeks
measure: The 7-item Generalised Anxiety Disorder scale (GAD-7)
timeFrame: Past 2 weeks
measure: The Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Past 12 months
measure: The Drug Use Disorders Identification Test (DUDIT)
timeFrame: Past 12 months
measure: the 26-item World Health Organization Quality of Life-BREF (WHOQOL-BREF)
timeFrame: Past 2 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: eStöd
Study officials:
affiliation: Karolinska Institutet
name: Philip H Lindner, PhD
role: STUDY_CHAIR
References:
citation: Molander O, Lindner P, Ramnero J, Bjureberg J, Carlbring P, Berman AH. Internet-based cognitive behavior therapy for problem gambling in routine care: protocol for a non-randomized pilot and feasibility trial. Pilot Feasibility Stud. 2020 Jul 21;6:106. doi: 10.1186/s40814-020-00647-5. eCollection 2020.
Clinical trial NCT00216398: Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR
Official title: A Phase IV, Open-label, Single Group Study to Evaluate the Dosing, Efficacy and Safety of Lanreotide Autogel® in Patients With Acromegaly Previously Treated With Octreotide LAR
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acromegaly
Keywords: acromegaly
growth hormone
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 8
Sex: ALL
Minimum age (years): 18
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 assess the efficacy, safety and patient acceptability of Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acromegaly
* The patient must have been tested at Week -4 (4 weeks prior to the Baseline visit) and shown to have a GH level \<10 mU/L.
* The patient must have been treated with a stable dose of octreotide LAR for at least four months prior to study entry
* Life expectancy of at least 2 years

Exclusion Criteria:

* Adenectomy within past 6 months, or likely during study period
* Radiotherapy for acromegalic disease within 1 year, or likely during study period
* Unstable concomitant dopamine agonist therapy

Primary outcomes:
measure: The percentage of patients with GH control (<5.0 mU.L) and normalised IGF-1 at week 44 compared to the baseline (Week 0) visit.
Secondary outcomes:
measure: The percentage of patients with GH control (< 5.0 mU/L) at each visit to week 44 compared to the baseline (Week 0) visit.
measure: The percentage of patients with normalised IGF-1 compared to the baseline visit.
measure: Change in the GH values compared to the baseline (Week 0) visit.
measure: Change in the IGF-1 values compared to the baseline (Week 0) visit.
measure: Change in serum lanreotide levels compared to the baseline (Week 0) visit.
measure: Change in the serum octreotide levels compared to the baseline visit.
measure: Patient evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.
measure: Investigator evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
Study officials:
affiliation: Ipsen
name: Ipsen Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01908998: Influence of Supportive Sandals on Y-Balance Performance on Healthy Young Individuals
Official title: Influence of Supportive Sandals on Y-Balance Performance on Healthy Young Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Y-balance Performance
Keywords: Y-Balance test
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2013-07-26
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The Y-balance test is a lower extremity, dynamic test performed in single limb stance that measures a person's ability to reach in 3 directions. The test is typically conducted in barefoot. The purpose of this study is to assess the impact of footwear on Y-Balance test scores. The investigators hypothesize that by improving alignment and augmenting muscle mechanics, sandals with medial arch support may improve Y-Balance scores.


Eligibility criteria: Inclusion Criteria:

* Men or Women between the ages of 21 to 40 years, inclusive
* Grossly intact and symmetrical neuromuscular status
* Able to ambulate without difficult or pain
* Able to understand the information in the informed consent form
* willing and able to sign informed consent form

Exclusion Criteria:

* history of ankle sprain, Anterior cruciate ligament injury; recent hip, knee, foot or ankle pain within past 6 months
* Uncontrolled Heart (Hypertension; BP \>= 140/90), Lung Disease (uncontrolled asthma or shortness of breath), or diabetes
* Nursing or pregnant
* Not willing or able to follow procedures specified by protocol and/or instructions of the study personnel
* Unable to fit into available shoe sizes

Primary outcomes:
measure: Y-Balance Test Score
timeFrame: Day 1
Secondary outcomes:
measure: Arch Height Index
timeFrame: Day 1
Other outcomes:
measure: Malleolar Valgus Index
timeFrame: Day 1
measure: EMED-X
timeFrame: Day 1
measure: GaitMatII
timeFrame: Day 1
Locations:
city: Philadelphia
country: United States
facility: Temple University School of Podiatric Medicine
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Steven J Pettineo, DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Temple University
name: Jinsup Song, DPM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00523198: Correlation Salivary Cortisol and Free Serum Cortisol to Total Serum Cortisol in MICU Septic Shock
Official title: Correlation Between Salivary Cortisol and Free Serum Cortisol Compared to Total Serum Cortisol in MICU Patients With Septic Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Shock
Keywords: Cortisol
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2007-08-31
Enrollment: 60
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: MICU patients with septic shock

Brief summary: The purpose of the study is:

* to correlate salivary cortisol to free serum cortisol (as salivary cortisol is considered to be almost complete free cortisol) and,
* to correlate free serum cortisol to total serum cortisol levels

Both in patients with septic shock (severe sepsis requiring vasopressors).

We believe that:

* total serum cortisol does not correlate with free serum cortisol in patient with septic shock and,
* that salivary cortisol correlates with free serum cortisol and can be used to determine the level of free serum cortisol.

Detailed description: Free serum cortisol is considered the active hormone.

In patients with septic shock only the total serum cortisol level is available, however, the free cortisol level can be normal despite a low total cortisol level due to changes in the serum protein.

The hormone can be replaced improperly in these patients and contribute to poor outcome in septic shock.

We are studying adult MICU patients with septic shock who are not receiving corticosteroid replacement.

This study does not include any intervention.

In-hospital or 28-day mortality are registered in all the patients.

Eligibility criteria: Inclusion Criteria:

* Adult patients with septic shock

Exclusion Criteria:

* Corticosteroid replacement
* Blood in mouth

Primary outcomes:
measure: Salivary cortisol
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas- Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas-Health Science Center at Houston / Division of Pulmonary, Sleep and Critical Care Medicine
name: Rosa M Estrada-Y-Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Estrada-Y-Martin RM, Orlander PR. Salivary cortisol can replace free serum cortisol measurements in patients with septic shock. Chest. 2011 Nov;140(5):1216-1222. doi: 10.1378/chest.11-0448. Epub 2011 Aug 4.
Clinical trial NCT05617898: Determining the Role of Social Reward Learning in Social Anhedonia
Official title: Determining the Role of Social Reward Learning in Social Anhedonia in First-Episode Psychosis Using Motivational Interviewing in a Perturbation-Based Neuroimaging Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychosis
Keywords: social anhedonia, social reward learning, fMRI, sensitivity to reward
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: National Institute of Mental Health (NIMH)
First posted: 2022-11-16
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a clinical trial study that aims to evaluate the specificity of the relationship between reduced sensitivity to social reward and social anhedonia at both behavioral and neural levels. Individuals who recently experienced their first-episode psychosis will be recruited. Participants will be randomized 1:1 to motivational interviewing or a time- and format-matched control probe. At pre- and post-probe, participants will perform two social reward learning tasks in the scanner. With this design feature, we will examine the relationship between sensitivity to social reward and reduced subjective experience of social pleasure at both the behavioral and neural levels.


Eligibility criteria: Inclusion Criteria:

* Age 18-35 years
* A first episode of a psychotic illness that began within the past three years
* Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder
* Taking 2nd generation antipsychotic medications
* Estimated premorbid IQ not less than 70 as assessed with the Wechsler Test of Adult Reading
* Appropriate for scanning (i.e., no pacemaker or metal implants) and expressed willingness to participate in scanning
* Sufficient fluency in English to comprehend testing procedures
* Corrected vision of at least 20/30

Exclusion Criteria:

* No evidence that substance use makes the diagnosis ambiguous (rule out substance-induced psychosis)
* No evidence of moderate or severe alcohol or substance use disorder in the past 3 months
* No clinically significant disease based on medical history (e.g., epilepsy) or significant head injury
* For females: no current pregnancy
* No sedatives or anxiolytics on the day of assessment
* No medication change 3 weeks prior to enrollment

Primary outcomes:
measure: Response Bias
timeFrame: 3 weeks
measure: the number of optimal response
timeFrame: 3 weeks
measure: fMRI activation levels
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
Study officials:
References:
Clinical trial NCT01957098: The Effects of L-Arabinose and D-xylose on Intestinal Sucrase Activity in Man
Official title: The Effects of L-Arabinose and D-xylose on Intestinal Sucrase Activity in Man
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Keywords: L-arabinose
D-xylose
sucrose
glucose
insulin
C-peptide
GLP-1
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Danisco
First posted: 2013-10-08
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the effect of L-arabinose and D-xylose in a sugar-rich drink on intestinal sucrase activity in healthy volunteers by measuring postprandial blood glucose and insulin, and selected intestinal hormonal responses to increasing doses of L-arabinose and D-xylose.

Detailed description: Based on previous scientific results we hypotesize, that pentoses decreases the demand for insulin in metabolizing a given dose of sucrose.

Eligibility criteria: Inclusion Criteria:

* healthy males
* BMI between 18.4-25 kg/m2
* age between 18 and 30

Exclusion Criteria:

* donation of blood 3 months before or during the study
* gastrointestinal disorders, diabetes, hypertension, hyperlipidemia, chronic infectious disease (HIV or hepatitis)
* smoking
* consumption of more than 21 alcoholic drinks/week
* elite athletes
* on medication

Primary outcomes:
measure: Blood glucose, insulin, C-peptide and GLP-1
timeFrame: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
Secondary outcomes:
measure: Appetite measurements and energy intake
timeFrame: -15, 30, 60, 90, 120, 150 and 180 min
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Institute of Human Nutrition, The Royal Veterinary and Agricultural University
Study officials:
affiliation: Department of Nutrition, Exercise and sports, University of Copenhagen
name: Jens R Andersen, MD,MPA
role: STUDY_CHAIR
References:
Clinical trial NCT00108498: New Pharmacological Treatment for Obstructive Sleep Apnea
Official title: New Pharmacological Treatment for Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obstructive Sleep Apnea
Keywords: sleep apnea
mirtazapine
sleep
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-04-18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will determine if mirtazapine, a unique antidepressant that does not disturb sleep, will improve obstructive sleep apnea (OSA). The design is randomized, crossover, double blind, and placebo controlled. On two consecutive nights of one week, the patients receive either 30 mg mirtazapine or placebo at bedtime. The following week, the alternative medication is administered. The patients have known mild to moderate sleep apnea. The endpoints of the study are the apnea + hypopnea index (AHI), sleep quality, and the degree of arterial oxygen desaturation.


Eligibility criteria: Inclusion Criteria:

* Known OSA mild to moderate

Exclusion Criteria:

* On antidepressant or antipsychotic medications

Primary outcomes:
measure: The apnea + hypopnea index (AHI)
measure: Sleep quality
measure: The degree of arterial oxygen desaturation
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Malcom Randall VAMC
state: Florida
Study officials:
References:
Clinical trial NCT01775098: Allopurinol in Acute Gout
Official title: Allopurinol in Acute Gout The Title Will Not be Change as the Study as Been Closed.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gout
Keywords: Gout
uric acid
allopurinol
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2013-01-24
Enrollment: 0
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 objectives of the present study are to determine if starting treatement of hyperuricemia with allopurinol during an acute gout crises has an impact on the duration or the severity of the crises


Eligibility criteria: Inclusion Criteria:

More than 18 years old Able to sign informed consent Indication of long-term treatment with allopurinol Acute gout crisis

Exclusion Criteria:

Les than 18 years-old Unable to consent Contra-indication to allopurinol

Primary outcomes:
measure: Duration of the gout crises
timeFrame: First 7 days after visit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03894098: High Ankle Block Versus Regional Block for Acute Pain Control After Ankle Surgery
Official title: High Ankle Block Versus Regional Block for Acute Pain Control After Ankle Surgery: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ankle Surgery
Keywords: nerve block
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 0
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: Researchers are trying to determine if a high ankle block during ankle surgery provides the same pain relief as the standard regional block.

Detailed description: Participants scheduled for elective ankle surgery will be randomized to have either a high ankle nerve block or a regional nerve block. Pain levels after surgery will be assessed to determine whether one type of block provides better pain relief compared to the other.

Eligibility criteria: Inclusion Criteria

* Adults undergoing elective foot and ankle surgery
* Adults ≥18 years, intact presurgical peripheral sensation based on 5.07 monofilament testing, foot and ankle surgery

Exclusion Criteria

* Presurgical neurologic discrepancies (peripheral neuropathy, radiculopathy)
* Complex regional pain syndrome
* peripheral nerve surgery
* Surgery above the level of the tibiotalar joint
* Narcotic dependency
* Anyone unable to receive a high ankle block

Primary outcomes:
measure: Change in pain score
timeFrame: 24 hours, 48 hours, 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Glenn G Shi, MD
role: PRINCIPAL_INVESTIGATOR
References: