louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01145248: Comparison of Biliary Forceps Biopsy and Brush Cytology
Official title: A Combination of Endoscopic Transpapillary Brush Cytology and a Novel Method of Forceps Biopsy to Diagnose Proximal Biliary Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholangiocarcinoma
Keywords: Cholangiocellular Carcinoma
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: Heidelberg University
First posted: 2010-06-16
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Cholangiocarcinomas (CCCs) are malignant tumors arising from the biliary epithelium. CCCs are characterised by a high mortality and the only curable therapy is complete tumor resection, if feasible, or in some cases liver transplantation. Since surgery for CCC is a procedure associated with a high mortality itself it needs to be ascertained that an accurate preoperative diagnosis has been established. However, it often appears to be difficult to get a preoperative pathological diagnosis, since it is difficult to obtain tumor specimens using cytologic brushings, biopsy forceps, bile aspiration or endoscopic ultrasonography guided-fine needle aspiration. This is reflected by a nearly 100% specificity but low sensitivity rates.

The aim of this study is to compare a new method of biliary biopsy using a double-balloon enteroscopy (DBE) forceps to enable a safe and reliable tissue specimen collection within the proximal biliary tract with cytology brushings in patients with suspected malignant proximal biliary strictures.


Eligibility criteria: Inclusion Criteria:

* biliary stenosis with suspected malignancy

Exclusion Criteria:

* no definite diagnosis available

Primary outcomes:
measure: Biopsy versus brush cytology for diagnosing CCC
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Department of Internal Medicine I, Ulm University Hospital
state: BW
Study officials:
affiliation: Department of Internal Medicine I, Ulm University Hospital
name: Hasan Kulaksiz, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01210248: Correlation Between CYP2C19 Genotype, Level Of Clopidogrel Metabolite And Platelet Inhibition Status
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PRIMARY FOCUS:PATIENT THAT TAKE CLOPIDOGREL
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-09-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: THE RESEARCH WILL INVOLVE PATIENTS THAT TAKE CLOPIDOGREL AND READY TO GIVE INFORMED CONSENT FOR GENETIC TESTING.

Brief summary: The aim of this study is to check correlation between CYP2C19 genotype level of clopidogrel metabolite in plasma and platelet inhibition status.

Detailed description: THE FIRST PHASE OF THE RESEARCH WILL INVOLVE PATIENTS RECRUITMENT AND INFORMED CONSENT FOR GENETIC TESTING.THE MAJORITY OF PATIENTS WILL BE RECRUITED FROM EMERGENCY DEPARTMENT. EVERY PATIENT WILL BE ASKED ABOUT HIS AND HIS PARENT'S ETHNICITY (ASHKENASI OR SEPHARDY JEW) AND ADDITIONAL DRUGS HE TAKES. IF PATIENT AGREES TO PARTICIPATE IN THE STUDY , HIS BLOOD SAMPLE WILL BE COLLECTED FOR 3 KINDS OF TESTS:

1. GENETIC (FOR CYP450 2C19)
2. PLATELET MAPPING TEST ( BY THROMBOELASTOGRAPH ASSAY)
3. CLOPIDOGREL INACTIVE METABOLITE DETERMINATION BY CHROMATOGRAPHIC METHOD

Eligibility criteria: Inclusion Criteria:

* \> 18 OLD PATIENTS
* THAT TAKE CLOPIDOGREL MORE THAN 1 WEEK

Exclusion Criteria:

* PREGNANCY
* CHRONIC LIVER DISEASES

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zeriffin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
References:
Clinical trial NCT06133348: Promoting Resilience in Women With Breast Cancer
Official title: Promoting Resilience in Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The PRISM (Promoting Resilience in Stress Management) intervention is an evidence-based program that builds resilience. This program was developed in adolescent and young adult oncology and utilizes centrally administered skills-based coaching to bolster positive psychological tools known as resilience resources. These resources include stress management, goal-setting, and positive reframing. Previous studies using this intervention have found PRISM to be successfully administered remotely and it has improved resilience, psychological distress, hope, and quality of life. Among adult caregivers, PRISM has shown to improve resilience, self-efficacy, and engagement with medical care. While PRISM successfully targets distress and associated downstream consequences known to be experienced by breast cancer survivors, it has not been utilized in adults with cancer or in marginalized communities. Adapting this intervention to this context will require the testing of the intervention and, importantly, tailoring to meet the needs of women with breast cancer, particularly those of marginalized populations who may uniquely benefit from this intervention.

Detailed description: This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.

Eligibility criteria: Inclusion Criteria:

* women undergoing neoadjuvant chemotherapy with early-stage breast cancer, women undergoing treatment for metastatic breast cancer

Exclusion Criteria:

* patients who do not speak English

Primary outcomes:
measure: Promoting Resilience in Women with Breast Cancer
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: The University of Alabama at Birmingham
name: Gabrielle Rocque, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04570748: Effect of Capsular Repair on the Outcomes of Direct Anterior Total Hip Arthroplasty.
Official title: Effect of Capsular Repair on the Outcomes of Direct Anterior Total Hip Arthroplasty.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coxarthrosis
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Total hip arthroplasty is a successful surgical procedure performed as a last-line treatment in primary and secondary coxarthrosis.

Recently, the direct anterior approach (DAA) has gained popularity by maintaining abduction force and reducing dislocation rates.

Soft tissue stability in the anterior is increased by adding capsule repair with the preservation of the posterior structures in the DAA.

The degradation of the biological structure of the capsule due to degenerative changes in the end stage coxarthrosis questions the effectiveness of the capsule repair. therefore, the effect of capsule repair on stability is still controversial.


Eligibility criteria: Inclusion Criteria:

* Elective unilateral or bilateral primary total hip arthroplasty
* Direct anterior surgical approach
* 18 years of age or older
* Avascular necrosis of the hip

Exclusion Criteria:

* Rheumatoid arthritis of the hip
* Revision hip arthroplasty
* Younger than 18 years of age
* Crowe type 3 and 4 coxarthrosis

Primary outcomes:
measure: Pelvis magnetic resonance ımages(MRI) evaluation of patients who underwent direct anterior total hip arthroplasty
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00913848: To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fed Conditions
Official title: A Single-Dose Comparative Bioavailability Study of Two Formulations of Divalproex Sodium 500 mg Delayed Release Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epilepsy
Bipolar Disorder
Keywords: Treatment of Epilepsy and Bipolar Disorder
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 30
Sex: MALE
Minimum age (years): 21
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release tablets under fed conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pharma Medica Research, Inc.
name: Xueyu (Eric) Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00231348: Nefazodone in the Treatment of Social Phobia
Official title: Nefazodone in the Treatment of Social Phobia: Functional Brain Imaging and Neuroendocrine Correlates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Social Anxiety Disorder (SAD)
Keywords: Social anxiety disorder
social phobia
positron emission tomography (PET
regional cerebral blood flow (rCBF)
nefazodone
amygdala
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-10-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of nefazadone in patients with social anxiety disorder (SAD).

Detailed description: The purpose of this study is to examine the efficacy of the 5HT2 receptor antagonist nefazadone in SAD, and to explore regional cerebral blood flow in patients with SAD when confronted with a personal phobic stimulus, using positron emission tomography (PET). Changes in cerebral blood flow were correlated with self-rated anxiety measures.

Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of generalized social anxiety disorder, males and females between the ages of 18-65

Exclusion Criteria:

* A history of bipolar disorder, psychotic illness, or any other anxiety disorders, organic brain disease or active drug or alcohol abuse within one year as assessed by the SCID-P and interview, or a concurrent medical condition that would not be compatible with the study in the opinion of the principal investigator. Patients required to be free of psychotropic or beta-blocker medication for 2 weeks prior to study. Pts taking fluoxetine required to be drug-free for 6 weeks.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Depatment of Psychiatry and Behavioral Sciences
state: Georgia
Study officials:
affiliation: Emory University Department of Psychiatry and Behavioral Sciences
name: Charles B Nemeroff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University Department of Psychiatry and Behavioral Sciences
name: Clinton D Kilts, PhD
role: STUDY_DIRECTOR
affiliation: Emory University Department of Psychiatry and Behavioral Sciences
name: Jeffrey Newport, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06481748: Unleashing Unpredictability: The Batman Project and Its Impact on Prosocial Behavior and Awareness
Official title: The Batman Project: Can Unpredictability Foster Prosocial Behaviour Through Increased Awareness?
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Social Behavior
Keywords: mindfulness
attention
Batman
awareness
prosociality
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -All metro passengers present at the time of the experiment are potential participants.

Brief summary: The proposed study is an observational investigation that aims to examine the impact of an unexpected and unusual event on prosociality within the Milan metro. The event is the simple presence, in the underground car, of a student wearing a Batman suit. The main objective is to assess whether or not the presence of the unusual event influences prosocial behaviour towards a student pretending to be pregnant. During the study, the student, equipped with a sponge prosthesis to simulate a pregnancy will board the underground. She will be asked not to interact with anyone, but to simply look at her phone. In the experimental condition, an individual dressed as Batman will enter the carriage (through a different door than the one used by the student). In the control condition, on the other hand, no one will show up in costume. In addition, the observer will try to gather information on the reason for this prosocial behaviour, noting down the answer given.


Eligibility criteria: Inclusion Criteria:

* Being a passenger in the metro

Exclusion Criteria:

* Metro too crowded
* Seats available

Primary outcomes:
measure: Prosocial behavior
timeFrame: 5 minutes
Secondary outcomes:
measure: Awareness
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04101448: Prevalence of Bronchiectasis in COPD Patients
Official title: Prevalence of and Prognostic Impact of Bronchiectasis in COPD Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchiectasis
Chronic Obstruct Airways Disease
Prognosis
Keywords: Bronchiectasis
COPD
Prevalence
Prognosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients diagnosed based on GOLD criteria 2019 with chest CT finding of bronchiectasis

Brief summary: The identification of bronchiectasis in COPD has been defined as a different clinical COPD phenotype with greater symptomatic severity, more frequent chronic bronchial infection and exacerbations, and poor prognosis. A causal association has not yet been proven, but it is biologically plausible that COPD, and particularly the infective and exacerbator COPD phenotypes, could be the cause of bronchiectasis without any other known etiology, beyond any mere association or comorbidity.

Detailed description: The relationship between bronchiectasis and COPD has generated several questions. Is there any real increased prevalence of bronchiectasis in patients with COPD? Does the presence of bronchiectasis have an impact on the clinical characteristics, prognosis, or response to treatment in COPD, to the extent that it can be considered a distinct clinical phenotype? Should bronchiectasis in patients with COPD be seen as merely a comorbidity, or as a consequence of the disease's natural history? Is there a causal relationship between COPD and bronchiectasis? If this is the case, what are the pathophysiological mechanisms responsible for this relationship? And, finally, what is the role of chronic bronchial infection and exacerbations in this relationship?

Eligibility criteria: Inclusion Criteria:

* COPD patients based on GOLD 2019 criteria, stable or in exacerbation

Exclusion Criteria:

* acute pneumonia within 2 months
* malignancy
* congenital bronchiectasis ( immobile cilia syndrome, Kartagnar syndrome).
* Pregnancy

Primary outcomes:
measure: Prevalence of Bronchiectasis in COPD
timeFrame: 1 year
Secondary outcomes:
measure: impact of bronchiectasis on COPD exacerbations
timeFrame: 1 year
measure: impact of bronchiectasis on COPD hospitalization
timeFrame: 1 year
measure: impact of bronchiectasis on COPD intensive care admission
timeFrame: 1 year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: AssiutU
Study officials:
References:
Clinical trial NCT06428448: Study to Evaluate the REMEDY SPECTRUM IM Spacer Nail in the Treatment of Ankle-Related Infections
Official title: A Prospective, Multi-Center Study to Evaluate the Safety and Effectiveness of the REMEDY SPECTRUM IM Spacer Nail in the Treatment of Ankle-Related Infections
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Periprosthetic Joint Infection
Keywords: Ankle-related Infections
Lead sponsor: OsteoRemedies, LLC
Sponsor class: INDUSTRY
Collaborators: name: MCRA
First posted: 2024-05-24
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being conducted to evaluate the safety and effectiveness of the REMEDY SPECTRUM IM Spacer Nail in the treatment of ankle-related infections. The study is expected to take approximately 18 months from first subject enrolled to the last follow-up visit. It will have a 12-month enrollment period and a 6-month follow-up. This study is a Prospective, multicenter, single-arm clinical trial. All subjects enrolled in this study will receive the REMEDY SPECTRUM IM Spacer Nail.


Eligibility criteria: Inclusion Criteria:

1. Be ≥ 21 years of age
2. Have an ankle-related infection
3. Is skeletally mature, as evidenced by closed epiphyses.
4. Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
5. Be willing and able to comply with all study procedures including all pre-operative, post-operative requirements
6. If female and of child-bearing potential, must have a negative pregnancy test prior to the surgical procedure and no intention of becoming pregnant until study completion.

Exclusion Criteria:

1. Infections that do not involve the ankle
2. Have a known immunodeficiency; including subjects who are receiving or have received immunosuppressants, immunostimulating agents or radiation therapy within 6 months prior to surgery
3. Affected limb is dysvascular
4. Where adequate soft-tissue coverage cannot be achieved
5. Have any mental or psychological disorder that would impair their ability to complete the study questionnaires
6. Are currently pregnant or breastfeeding, or planning to become pregnant or breastfeed any time during the course of the study
7. Are currently a prisoner
8. Have any medical condition or other circumstances, in the judgment of the Investigator, that might interfere with the ability to return for follow-up visits, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate post-operative activities.
9. History of vancomycin or gentamicin allergy
10. Are implanted with other antibiotic eluting products.

Primary outcomes:
measure: Successful Treatment of Infection Based on Lab Values and Culture
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: OsteoRemedies, LLC
name: Rachel McGuire Kennedy
role: STUDY_DIRECTOR
References:
Clinical trial NCT04672148: Prognostic Factors and Mortality in Older Stroke Patients With Mechanical Thrombectomy
Official title: Prognostic Factors in Disease Progression and Mortality Risk in the Older Stroke Patients With Mechanical Thrombectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Ischemic
Keywords: Thrombectomy,acute ischemic stroke
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 48
Sex: ALL
Minimum age (years): 80
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. elderly (older than 80 years old)
2. acute ischemic stroke in anterior circulation
3. NIHSS more than 8

Brief summary: The study focus on the elderly patient (older than 80 years of age) who had acute ischemic stroke and received mechanical thrombectomy. The investigators analyze different factors in the stage of before, between, after procedure and trying to figure out if there is any difference between the 30-day-mortality group versus non-30-day-mortality group.

Detailed description: With the constant improvements in health care, standard of living and the decrease birth rate, the percentage of the elderly population ( above 80 years old) is expected to double in Taiwan by the year 2044, according to data from the National Development Council. Consequently with the increase in the proportion of senior citizens, there will be an surge number of patient suffering from cardiovascular and cerebrovascular diseases, most importantly acute ischemic stroke. In recent years, mechanical thrombectomy has become the gold standard in the treatment for acute stroke patients, however, many studies have excluded the patients above the age of 80 years old as the benefits of the procedure have been very controversial and there is no clear evidence proving favorable a outcome. There are a few studies which state that though elderly patients had higher risk of complications when receiving mechanical thrombectomy as compared to younger patients, the prognosis was still superior to those didn't receive any intervention. Previous studies put more emphasis on the overall prognosis, morbidity and mortality rate, they didn't focused on the cause of mortality.

The study focuses on analyzing of the cause of mortality and whether there is a significant difference between 30-day-mortality group versus non-30-day-mortality group.

Eligibility criteria: Inclusion criteria:

1. elderly (older than 80 years old)
2. acute ischemic stroke in anterior circulation
3. NIHSS more than 8

Exclusion Criteria:

1. posterior infarction
2. ASPECT score less than 3

Primary outcomes:
measure: 30 days mortality
timeFrame: 30 days
Secondary outcomes:
measure: The cause of mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: New Taipei city
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: FEMH
name: Szu-Hsiang Peng, MD
role: PRINCIPAL_INVESTIGATOR
References: