louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00475514: A Controlled Trial to Investigate the Efficacy and Safety of Frovatriptan to Prevent Menstrual Migraine
Official title: A Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, and Safety of Oral Frovatriptan in the Prevention on Menstrually-related Migraine (MRM) Headaches in a 'Difficult to Treat' Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Keywords: Menstrually-related Migraine Headache
'Difficult to Treat' as specified in protocol
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-05-21
Enrollment: 500
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Although the predictability of an MRM headache attack lends itself to preventative treatment, there are currently no drugs specifically indicated for the prevention of MM. Such preventative therapies might be administered either short term (during the time around the period otherwise known as the peri-menstrual period or PMP) or continuously throughout the menstrual cycle.

Frovatriptan has been developed for the management of migraine and is already licensed for use as an acute treatment for this condition. Previous well controlled clinical trials have highlighted the potential of frovatriptan as a short-term preventative medication for MM. This clinical trial was meant to further explore this indication for frovatriptan in an expanded population.

Detailed description: See above

Eligibility criteria: Inclusion Criteria:

* Pre-menopausal females diagnosed as suffering from MRM aged 15 years and over, that fit the criteria for 'difficult to treat'

Primary outcomes:
measure: Primary endpoint Number of MRM headache free PMPs out of a potential of three treated PMPs
Secondary outcomes:
measure: Incidence of MRM headache
measure: Maximum headache intensity
measure: Incidence of moderate or severe MRM headaches
measure: Number of MRM headache free days during treated PMPs
measure: Incidence of MRM headache associated symptoms (e.g. photophobia, phonophobia, nausea and vomiting)
measure: Functional impairment during treatment phase
measure: Time to onset (days) of MRM headache (during the treated PMP and until five days post treatment)
measure: Time to onset of first post-treatment migraine Incidence of intercurrent migraine outside of the peri-menstrual period Use of rescue medication
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03469414: Manual Wheelchair Speed, Maneuverability, and Endurance and Community Access
Official title: Manual Wheelchair Speed, Maneuverability, and Endurance and Community Access
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Physical Disability
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 1
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: 260 participants with disabilities who use manual wheelchairs for their primary mobility. Participants will be recruited from all Courage Kenny Rehabilitation Institute sites. Participants will have a mixture of diagnosis, with a minimum of 30 individuals with diagnosis of stroke and 30 individuals with diagnosis with spinal cord injury.

Brief summary: This is a cross-section correlational study that will examine the relationships between wheelchair speed, maneuverability, and endurance with community integration. By identifying which of these has the biggest contribution to community participation, the information will be used to justify continues therapy, to alter the focus of therapy, and to justify purchase of power or power assist wheelchairs when needed. Currently, therapists make the recommendation for a power or power assist chair based on their clinical judgement and the patient's experience, but there has been limited justification from the literature for these decisions. Finally, because the CHART measure is the gold standard in rehabilitation research for community integration, but has psychometric problems, we will use this opportunity to validate a new more psychometrically solid measure, the PART-O, against the CHART.


Eligibility criteria: Inclusion criteria include:

* 18 years or older
* presence of a physical disability
* use of a manual wheelchair for primary mobility
* living in the community.

Exclusion criteria would include:

* individuals who have significant expressive or receptive language deficits (i.e. aphasia, verbal apraxia, etc.)
* limb orthopedic conditions that would contraindicate speed and endurance testing, such as recent fractures or joint instability
* cardiopulmonary resting heart rate of less than 50 or over 100, resting vitals of systolic blood pressure of \> 200 or \< 90, diastolic blood pressure of \>110, resting O2 levels of less than 90 (ACSM, 205; Fletcher, et al., 1993).
* any other cardiac symptoms

Primary outcomes:
measure: Life Space Assessment Scale Score
timeFrame: Day 0
Secondary outcomes:
measure: Distance (meters) covered in six-minute push test
timeFrame: Day 0
measure: Average time to complete forward push test
timeFrame: Day 0
measure: Time to complete Manual Wheelchair slalom Test
timeFrame: Day 0
Other outcomes:
Locations:
city: Golden Valley
country: United States
facility: Courage Kenny Rehabilitation Institute
state: Minnesota
Study officials:
affiliation: Allina Health
name: Nancy Flinn, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06846814: Second-Look Ultrasound Post Contrast-Enhanced Mammography for Additional Lesions Characterization
Official title: Second-Look Ultrasound Post Contrast-Enhanced Mammography for Additional Lesions Characterization
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Breast Cancer Diagnosis
Breast Cancer Detection
Keywords: Second look ultrasound
contrast enhanced mammography
breast cancer detection
Lead sponsor: Link Campus University
Sponsor class: OTHER
Collaborators: name: Link Campus University
name: University of Campania Luigi Vanvitelli
First posted: 2025-02-26
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 18 years and older undergoing CEM as part of diagnostic or surveillance protocols.

Lesions detected by CEM that require additional characterization.

Brief summary: This study investigates the utility of second-look ultrasound (US) following contrast-enhanced mammography (CEM) to characterize additional lesions detected during routine breast imaging.

Detailed description: The goal is to assess the diagnostic accuracy and clinical value of combining CEM with targeted ultrasound to improve lesion characterization and guide biopsy decisions.

Eligibility criteria: INCLUSION CRITERIA:

* Patients undergoing contrast-enhanced mammography for diagnostic or surveillance purposes.
* Identification of additional lesions on CEM requiring further evaluation.
* Ability to provide informed consent.

EXCLUSION CRITERIA:

* Known breast cancer diagnosis without suspicion of additional lesions.
* Contraindications to ultrasound or contrast agents.
* Patients with incomplete imaging data.

Primary outcomes:
measure: Detection Rate of Additional Lesions on CEM
timeFrame: Within 12 months of imaging assessment.
Secondary outcomes:
measure: Concordance Between Imaging Findings and Histopathology
timeFrame: Up to 3 months post-biopsy.
measure: Concordance Between Imaging Findings and Follow-Up Imaging
timeFrame: 6-12 months after the initial CEM examination
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Campania Luigi Vanvitelli
Study officials:
affiliation: Link Campus University
name: Graziella Di Grezia, Medicine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06956014: Efficacy and Safety of VER-01 in the Treatment of Patients With Chronic Low Back Pain
Official title: Multicenter, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of the Full-spectrum Cannabis Extract VER-01 in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Chronic Low Back Pain
Lead sponsor: Vertanical GmbH
Sponsor class: INDUSTRY
First posted: 2025-05-02
Enrollment: 700
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 aim of the trial is to prove the efficacy and safety of VER-01 corresponding to 22.5 mg or 32.5 mg THC compared to placebo in patients with chronic low back pain (CLBP) for whom drug treatment is indicated and previous optimized treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance.


Eligibility criteria: Inclusion Criteria:

* Chronic (≥ 6 months) pain in the lower back (between the 12th thoracic vertebra and lower gluteal folds). CLBP patients without a clear specific somatic cause, for which targeted therapy can have a positive effect on the course of the disease.
* Patients with indicated opioid drug treatment where previous optimized treatments with non-opioid analgesics (including combinations) have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance

Exclusion Criteria:

* Any painful comorbidity which could, in the opinion of the investigator, interfere with the low back pain intensity assessment during the trial participation
* Pregnant or breastfeeding female patients
* Known history of previous or current severe psychiatric disorder as per DSM-5 (e.g., schizophrenia, bipolar disorder, severe anxiety disorder, psychotic disorder, post-traumatic stress disorder), or currently taking antipsychotic medication.
* Cardiovascular event or clinically significant cardiac dysfunction (e.g., congestive heart failure, myocardial ischemia, arrhythmias, poorly controlled high blood pressure, congenital long QT syndrome) within 12 months prior to Visit 1 or a cardiac disorder that, in the opinion of the investigator, would put the patient at risk of a clinically significant arrhythmia or myocardial infarction.

Primary outcomes:
measure: Efficacy based on pain reduction
timeFrame: From Baseline to Treatment Week 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05940714: Periodontopathogens of Periodontal Patients
Official title: Detection of Levels of Periodontopathogens in a Catalan Population of Periodontal Patients Visited in the HOUB
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontal Diseases
Keywords: periodontopathogens
oral hygiene
periodontal patients
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: Teresa Vinuesa Aumedes
name: Albert Estrugo Devesa
name: Felipe Aguilera Muñoz
name: Ester Fuste Domínguez
name: Enric Jané Salas
name: Isabel Martínez Lizán
name: Sonia Egido Moreno
name: Carlos Omaña Cepeda
name: Alexandra Merlos Gil
First posted: 2023-07-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Study the presence of periodontal pathogens in a Catalan population with periodontitis and evaluate the influence of an intervention measure on oral hygiene teaching (video)


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* periodontal disease (grade III and IV)
* gave their informed consent to participate in the study
* do not present associated medical pathology

Exclusion Criteria:

* Patients who do not wish to participate in the study
* Patients following active treatment with antibiotics or having received antibiotic treatment in the last seven days,
* Patients who wear braces.

Primary outcomes:
measure: Presence of periodontopathogens
timeFrame: 1 month
Secondary outcomes:
measure: Correlate the microbiota and pro-inflammatory cytokine data obtained in the study population with the literature.
timeFrame: 1 month
measure: Determine if there are changes in the oral microbiota, before and after an intervention in the form of oral hygiene.
timeFrame: 1 month
measure: Determine if there are changes in the levels of pro-inflammatory cytokines, before and after an intervention measure in the form of oral hygiene.
timeFrame: 1 month
measure: Correlate the level of periodontal disease with the patient's oral health.
timeFrame: 1 month
measure: Correlate the level of periodontal disease with the patient's systemic diseases
timeFrame: 1 month
measure: Correlate the variations in the oral microbiota with the patient's systemic diseases.
timeFrame: 1 month
measure: Correlate variations in the levels of pro-inflammatory cytokines with the patient's systemic diseases.
timeFrame: 1 month
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: University of Barcelona
state: Barcelona
Study officials:
References:
Clinical trial NCT01619514: Uncovering Potential Breast Cancer Biomarkers Amp; Possible Drug Targets Using Advanced Quantitative Mass Spectrometry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2012-06-14
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tumor specimens that have been stored in the NUHS tissue repository will be retrieved

Brief summary: The purpose of this study is to evaluate the use of advanced quantitative mass spectometry (Super SILAC) as a discovery platform to uncover novel protein biomarkers in tumor and to compare the protein profile between different subtypes of breast cancer (ER positive, HER2 positive, triple negative). A maximum of 100 breast tumor specimens will be obtained from the NUHS Tissue repository, comprising approximately equal proportion of ER positive, HER2 positive, and triple negative tumors. Samples will be analyzed using advanced Mass Spectrometry (Super SILAC) as a discovery platform to identify novel protein biomarkers that may be important in cancer. DNA and RNA will also be extracted from tumor samples for correlative analysis with the proteomics data. Genomics and proteomics data will be correlated with clinical data including treatment response and survival data. Importance of proposed research to science or medicine:Identification of tumor biomarkers may allow better prognostication, follow-up, and selection of treatment for cancer patients in the future. Potential benefits and risks: No direct benefit to the patient. Risk to the subjects is minimal as there is no direct patient contact, and analysis is done on previously donated tumor samples. Patients have previously provided consent to donate their samples for research into the NUHS Tissue Repository.

Novel tumor biomarkers that determine tumor biology, including prognosis and treatment sensitivity, may be detectable using the novel advanced quantitative mass spectromy method (Super SILAC). Different subtypes of breast cancers will have different proteomic profiles analyzed using super SILAC.


Eligibility criteria: Inclusion Criteria:

* Patients with breast cancer

Primary outcomes:
measure: Evaluate the use of advanced quantitative mass spectometry (Super SILAC) as a discovery platform to uncover novel protein biomarkers in tumor
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Nationa University Hospital
Study officials:
References:
citation: Geiger T, Cox J, Ostasiewicz P, Wisniewski JR, Mann M. Super-SILAC mix for quantitative proteomics of human tumor tissue. Nat Methods. 2010 May;7(5):383-5. doi: 10.1038/nmeth.1446. Epub 2010 Apr 4.
citation: Neubert TA, Tempst P. Super-SILAC for tumors and tissues. Nat Methods. 2010 May;7(5):361-2. doi: 10.1038/nmeth0510-361. No abstract available.
Clinical trial NCT06469814: Snapshot Study on Patients With Heart Failure
Official title: Global Registries And Surveys Programme - Heart Failure Snapshot Study (GRASP-HF)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Failure
Lead sponsor: European Society of Cardiology
Sponsor class: NETWORK
First posted: 2024-06-24
Enrollment: 4000
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: The study population is all consenting patients seen in the outpatient clinic for chronic HF and all consenting patients admitted for acute HF in the study center as their standard medical care.

Brief summary: The goal of this observational study is to provide a better understanding of medical practice for heart failure management based on real-world data, collected both across Europe and the rest of the world, using robust methodology and representativeness within each country.

Standard management of patients will be the diagnostic and therapeutic interventions routinely performed in each center for patients presenting with signs and symptoms of chronic/acute heart failure.


Eligibility criteria: Inclusion Criteria:

Adult patients with chronic or acute Heart Failure (HF), regardless of ejection fraction, either:

• Outpatient with chronic HF (including first-time diagnosis), according to the clinical judgment.

OR

• Patients admitted to hospital or presenting to Emergency Department or Acute out-patient care for acute HF for whom an IV (diuretics, inotropes, vasodilators) or mechanical therapy for HF (mechanical circulatory support) is administered.

Exclusion Criteria:

* Age \<18 years
* Patients unwilling to consent (or patient's legally authorized representative unwilling to consent, if the patient is unable to consent).

Primary outcomes:
measure: Adherence to ESC Guidelines in Heart Failure 2021
timeFrame: 12 months per site
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institute for Cardiovascular Diseases C.C. Iliescu, Bucaresti, Romania
name: Ovidiu Chioncel
role: STUDY_CHAIR
References:
Clinical trial NCT01584414: Evaluation of the Zetiq Histological and Cytological Staining Technique for the Detection Cervical Cancer
Official title: Evaluation of the Zetiq Histological and Cytological Staining Technique for the Detection Cervical Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: Zetiq CellDetect ® stain
distinct red/purple color to the cytoplasm of neoplastic
distinguishes green/blue stained non-neoplastic cells and tissues
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2012-04-25
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 archival cervical biopsy cases with the following diagnoses: normal, 22 cases; CIN-2/3, 18 cases; squamous cell carcinoma, 20 cases.

Brief summary: Zetiq has introduced a histochemical stain that claims to tinctorially identify cancer and neoplastic cells. Because of the potential importance of such a capability, the investigators undertook to investigate Zetiq's CellDetect® staining technology as applied to cultured cell lines as well as an initial sample of clinical cases. This goal was pursued by investigating four types of comparisons: 1) cancer cell lines before and after differentiation; 2) cervical squamous-cell carcinoma (SCC) biopsies to non-neoplastic squamous epithelium; 3) SCCs to neoplastic, nonmalignant squamous epithelium; and 4) neoplastic squamous cells to non-neoplastic squamous cells in cytological preparations. The clinical material was also stained with hematoxylin and eosin (biopsies) or Pap (cytologies) for diagnostic purposes. The investigators found that all CellDetect®-stained cells exhibited one of the two tinctorial outcomes. Cell lines with malignant phenotype uniformly had red/purple cytoplasm, whereas the differentiated phenotype changed the color to blue/green.


Eligibility criteria: Inclusion Criteria:

1. FEMALE SUBJECT BETWEEN 18 AND 75 YEARS OF AGE.
2. ABILITY TO PROVIDE INFORMED CONSENT

Exclusion Criteria:

1. SUBJECT WITH KNOWN PREGNANCY AT TIME OF SCREENING.
2. PREVIOUS HISTORY OF HYSTERECTOMY
3. PARTICIPATION IN ANOTHER CLINICAL TRIAL WITHIN LAST 30 DAYS.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar - Sava
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir medical Center, affiliated with Sackler School of Medicine, Tel-Aviv University
name: Ami Fishman, Prof
role: PRINCIPAL_INVESTIGATOR
References: