louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03394716: Monitoring MRI Changes Before and During Radiotherapy Treatment of Brain Tumors
Official title: Monitoring MRI Changes Before and During Radiotherapy Treatment of Brain Tumors
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Brain Tumor
Keywords: MRI
Radiotherapy
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 45
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: Patients with metastasis in the brain from extracranial solid tumors or patients with primary brain tumors who will be treated with fractionated radiotherapy.

Brief summary: This study aims to evaluate anatomical and functional changes during RT for patients receiving fractionated RT for brain tumors. Anatomical changes during RT will be registered and analyzed and if needed the radiotherapy plan will be modified for the individual patient. This means that the "to be irradiated volume" will be modified according to the shape changes of the tumor. The functional MRI sequences will be used to evaluate what parameters, and at which time point, are important for radiotherapy outcome.


Eligibility criteria: Inclusion Criteria:

* Primary brain tumor (WHO IV, GBM); treated with fractionated radiotherapy with or without preceding surgery. Systemic treatment is allowed before and during radiotherapy.
* Brain metastasis (from a solid extracranial tumor) eligible for treatment with fractionated radiotherapy with or without preceding surgery. Systemic treatment is allowed before and during radiotherapy.

Also, postoperative patients with a macroscopic residual tumor lesion can be included (the diagnosis of residual diseases is defined by the treating neurosurgeon or on the MRI executed within 24 hours after the surgery, the diagnosis of residual macroscopic disease should always be confirmed during the neuro-oncology multidisciplinary meeting).

Exclusion Criteria:

* Patients receiving Whole Brain RT (WBRT)
* Patient with a poor kidney function (GFR \< 30 mL/min; CKD 4 and 5; patients on dialysis and patients with acute kidney insufficiency)
* None, doubtful or very small (\<5 mm in its largest dimension) contrast enhancing lesion
* Patients with a contraindication for MRI

Primary outcomes:
measure: MRI parameters in the target volume
timeFrame: through study completion, an average of 3 years
measure: anatomical variations in position, shape and size in the target volume
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
measure: the correlation between MRI parameters to the treatment outcome
timeFrame: through study completion, an average of 3 years
measure: the correlation between anatomical variations and the treatment outcome
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek
state: Noord-Holland
Study officials:
References:
Clinical trial NCT04133116: A Study of LY3471851 in Healthy Participants
Official title: A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3471851 in Japanese and Caucasian Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Nektar Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2019-10-21
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to explore the safety and tolerability of LY3471851 in healthy Japanese and Caucasian participants. The study will also estimate how much LY3471851 gets into the blood stream and how long it takes the body to remove it. The study is expected to last about 7 weeks for each participant.


Eligibility criteria: Inclusion Criteria:

* Are healthy males or females, as determined by medical history and physical examination
* Are first generation Japanese or are Caucasian
* Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive, at the time of screening

Exclusion Criteria:

* Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study
* Have an abnormal blood pressure and/or pulse rate as determined by the investigator
* Regularly use known drugs of abuse and/or show positive findings on drug screening
* Are immunocompromised per investigator judgment

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Study Completion (up to week 7)
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851
timeFrame: Predose on Day 1 through Day 50
measure: PK: Maximum Concentration (Cmax) of LY3471851
timeFrame: Predose on Day 1 through Day 50
Other outcomes:
Locations:
city: Cypress
country: United States
facility: WCCT Global
state: California
Study officials:
affiliation: Nektar Therapeutics
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00266916: Percutaneous Interventions in Adults With CHD
Official title: Percutaneous Interventions in Adults With Complex Cyanotic Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Disorders
Keywords: adult
congenital heart disease
percutaneous occlusion
percutaneous balloon valvotomy
balloon angioplasty
complex cyanotic congenital heart defects (CCHD)
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-12-20
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: The primary objective of this study is to determine the clinical benefits of percutaneous intervention to improve pulmonary blood flow on oxygen saturations, symptoms, exercise tolerance and hematocrit in patients with complex cyanotic congenital heart disease who are not candidates for surgical repair.

Detailed description: This is a single center, retrospective study of adult patients with a diagnosis of un-repaired complex cyanotic congenital heart disease including Eisenmenger's Syndrome, single ventricle, pulmonary atresia with aorticopulmonary collaterals, complete atrio-ventricular canal defects, double inlet left ventricle, heterotaxy syndromes and truncus arteriosus. Patients with surgically placed systemic to pulmonary artery shunts will be included.

Although generally incompatible with adult survival, rare patients with un-operated or palliated complex cyanotic congenital heart defects (CCHD) survive well into adulthood. Symptoms related to poor pulmonary blood flow and/ or increasing pulmonary vascular resistance progress with advancing age. Percutaneous interventions to improve symptoms and relieve hypoxemia have not been previously reported in adult patients with complex cyanotic congenital heart disease. Percutaneous interventions in patients with cyanotic congenital heart disease may be generally broken down into three types: percutaneous occlusion of shunt lesions, percutaneous balloon valvotomy or valvuloplasty, and balloon angioplasty and stenting of vascular structures (1). Percutaneous interventions for occluded or stenotic systemic to pulmonary artery shunts in childhood have been described (2,3). However, procedures to improve pulmonary blood flow in adults with CCHD have not previously been described.

Eligibility criteria: Inclusion Criteria:

* greater than 18 years of age
* complex cyanotic heart disease
* oxygen saturation prior to intervention \< 90%

Exclusion Criteria:

* those who do not meet inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta
name: Wendy M. Book, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02761616: A Study to Determine Biopsy Rate in Participants With a First Relapse of Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-05-04
Enrollment: 76
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: Participants with a first relapse of breast cancer after being treated for eBC.

Brief summary: This is a retrospective, and observational cohort study to determine the proportion of breast cancer first relapses, that are biopsied. The duration of the study will be approximately 24 months.


Eligibility criteria: Inclusion Criteria:

* Participants with histologically confirmed breast cancer treated for early breast cancer (eBC) with first metastatic relapse disease in the period from January 1, 2014 and December 31, 2015

Exclusion Criteria:

Not Applicable

Primary outcomes:
measure: Percentage of biopsied participants with metastatic relapse
timeFrame: Approximately up to 24 months
Secondary outcomes:
measure: Percentage of non-biopsied participants at first relapse according to different reasons for not performing a biopsy of the metastasis
timeFrame: Approximately up to 24 months
measure: Percentage of biopsied and non-biopsied participants at first relapse metastatic breast cancer (mBC) for each metastatic site
timeFrame: Approximately up to 24 months
measure: Percentage of biopsied participants at first relapse mBC according to each biopsy method
timeFrame: Approximately up to 24 months
measure: Percentage of biopsied and non- biopsied participants at first relapse mBC for each molecular profile of primary tumor
timeFrame: Approximately up to 24 months
measure: Percentage of biopsied participants at first relapse mBC for each molecular profile of biopsied metastases
timeFrame: Approximately up to 24 months
measure: Percentage of biopsied participants at first relapse mBC with same and different molecular profiles between primary tumor and metastasis for each molecular profile
timeFrame: Approximately up to 24 months
measure: Time to relapse
timeFrame: Approximately up to 24 months
measure: Percentage of participants with type of first line therapy selected for metastatic disease
timeFrame: Approximately up to 24 months
measure: Percentage of participants influenced with biopsy in mBC
timeFrame: Approximately up to 24 months
measure: Percentage of biopsied and non- biopsied participants at first relapse mBC for each systemic treatment scheme in the adjuvant and in the metastatic setting
timeFrame: Approximately up to 24 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Cemic; Oncologia Clinica
city: Moron
country: Argentina
facility: Hospital de Morón
city: Rosario
country: Argentina
facility: CENICLAR
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico San Roque
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03845816: Evaluation of Attachment, Self-compassion and Coping Strategies in Chronic Pain Patients
Official title: L'évaluation de l'Attachement, de l'Auto-compassion et Des stratégies de Coping Chez Les Patients Douloureux Chroniques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2019-02-19
Enrollment: 150
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: Patient newly treated at the pain center (i.e. any patient seen for the first time in a pain centre, and included in the research during one of the three medical consultations preliminary to overall management at the patient center)

Brief summary: Compare the self-compassionate score by type of attachment, "safe" or "insecure", in chronic pain patients.

Detailed description: Attachment theory proposes a theoretical model that helps us explain how the process of developing interpersonal relationships can affect the search for care and the response of individuals to an illness.

Self-compassion is a concept developed by Kristin Neff. It refers to the disposition of each individual to contain their feelings of suffering by a feeling of warmth, connection and care.

The coping corresponds to the answers, the reactions, that the individual will develop to control, reduce or simply tolerate the aversive situation. Coping can take the form of cognitions, affects and behaviors that an individual will put in place to deal with a situation.

The three concepts (attachment, self-compassion, coping) seem to be interrelated, and they contribute to the explanation and management of chronic pain, in the spectrum of the bio-psycho-social model of pain. Yet no study has measured these three variables together in chronic pain patients

Chronic and Newly Assisted Patients at CETD (Neurosurgery Department, Pain Assessment and Treatment Center) (ie any patient seen for the first time in pain center, and included in the research during one of the three medical consultations preliminary to overall care at the CETD).

Eligibility criteria: Inclusion Criteria:

* Chronic pain

Exclusion Criteria:

* Legal protection measure
* Patients followed for cancer
* Patients followed for multiple sclerosis
* Patients followed for Parkinson's disease
* Patients already followed in another CETD
* Decompensated psychiatric pathology

Primary outcomes:
measure: Self-Compassion Quetionnaire
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A de Rothschild
Study officials:
References:
Clinical trial NCT05062616: Patient Satisfaction After Ingrown Toenail Surgery
Official title: Patient Satisfaction After Ingrown Toenail Surgery. A Review of 1200 Cases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ingrowing Nail With Infection
Keywords: patient satisfaction
operative treatment
ingrown toenail
onychocryptosis
Lead sponsor: Goztepe Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 1200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who had ingrown toenail surgery between 8 and 80 years old.

Brief summary: In this study, demographic characteristics (age, gender, which toe is involved, family history) of the patients who were operated because of ingrown nails were examined, and the post-operative satisfaction score of the patients was noted, and the recurrence rate and complications were recorded.

Detailed description: The study was designed as single-center, single-surgeon observational study. Approximately 4000 patients who were operated on by the same surgeon between 2015-2020 due to ingrown nails were reached by phone, and patients' satisfaction was assessed by using the Surgical Satisfaction Questionnaire (SSQ-8). Outcomes such as retrospective treatment processes and complications were asked using a questionnaire, and patients' demographic characteristics were also recorded.

Eligibility criteria: Inclusion Criteria:

Patients who underwent ingrown toenail surgery Patients who could be reachable by phone over contact details on medical records

Exclusion Criteria:

Patients who were not reachable Patients who underwent another surgery on the targeted foot rather than ingrown toenail surgery Patients who had fractures on the targeted foot Clinical diagnosis of Alzheimer disease or patients who have lost their cognitive functions.

Primary outcomes:
measure: The Surgical Satisfaction Questionnaire (SSQ-8)
timeFrame: At least one year after surgery
Secondary outcomes:
measure: Recurrence
timeFrame: At least one year after surgery
measure: The shape of nail clipping
timeFrame: through study completion, an average of 2 years
measure: Family history
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Medeniyet University
state: Kadıköy
Study officials:
References:
Clinical trial NCT02137824: A Modified Sinus Floor Elevation Technique - a Pilot Study on 12 Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maxillary Sinus
Atrophy
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2014-05-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to establish a modified minimally invasive surgical technique for sinus floor augmentation with a residual bone height of 3-6mm.

Hypothesis: The investigators expect that the present surgical technique allows to achieve an adequate implant bed of at least 10mm height after a healing period of 3-5 months. Further the modification of the technique enables a reduced patient stress level.


Eligibility criteria: Inclusion Criteria:

* residual bone height of 3-6mm
* residual bone width of \>4mm

Exclusion Criteria:

* not treated periodontal disease
* smoker (\>5cig/day)
* acute or chronic sinusitis

Primary outcomes:
measure: Height of augmentation
timeFrame: after 4-5months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Bernhard Gottlieb School of Dentistry, Medical University of Vienna
Study officials:
References:
Clinical trial NCT05259124: The Ability of Perfusion Index and Positional Perfusion Index Variation to Predict Spinal Anesthesia-induced Hypotension in Elderly Patients
Official title: The Ability of Perfusion Index and Positional Perfusion Index Variation to Predict Spinal Anesthesia-induced Hypotension in Elderly Patients: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Anesthesia Induced Hypotension
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 68
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 68 consecutive elderly patients, aged \>65 years scheduled for elective surgical operations under spinal anesthesia will be included in the study.

Brief summary: In this study, we will test the ability of positional perfusion index variation to predict post-spinal anesthesia hypotension in elderly patients.


Eligibility criteria: Inclusion Criteria:

* 65 years of age or more.
* ASA score I \& II.
* Patients scheduled for surgeries under spinal anesthesia.

Exclusion Criteria:

* Negative consent.
* pre-existing hypertension
* Diabetes mellitus or autonomic neuropathy.
* Emergency operations.
* Absolute contraindications or failure to perform spinal anesthesia.

Primary outcomes:
measure: The sensitivity of perfusion index postural change in predicting spinal anesthesia-induced hypotension in elderly patients.
timeFrame: 30 minutes after spinal anesthesia
Secondary outcomes:
measure: incidence of spinal anesthesia induced hypotension in elderly
timeFrame: 30 minutes after spinal anesthesia
measure: • The sensitivity of supine perfusion index to predict spinal anesthesia-induced hypotension in elderly patients.
timeFrame: 30 minutes after spinal anesthesia
measure: • The sensitivity of sitting perfusion index to predict spinal anesthesia-induced hypotension in elderly patients.
timeFrame: 30 minutes after spinal anesthesia
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university hospital
state: Giza
Study officials:
References:
Clinical trial NCT03144024: Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency
Official title: Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tricuspid Regurgitation
Keywords: Tricuspid Regurgitation
Insufficiency, Tricuspid Valve
Valvular Annuloplasty
Cardiac Valve Annulus Repair
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2017-05-08
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: randomized study which include comparison rigid ring and band devices in treatment tricuspid regurgitation.

Detailed description: study include 308 patients. Patient will be randomized and 154 patient will receive band for treatment tricuspid regurgitation, rest patient will receive rigid ring. Follow up will be 1 year. Primary outcome - freedom of moderate or severe regurgitation. Secondary outcome - RV function, quality of life.

Eligibility criteria: Inclusion Criteria:

* moderate or severe tricuspid regurgitation

Exclusion Criteria:

* refusal to participate in the study

Primary outcomes:
measure: tricuspid regurgitation
timeFrame: 12 months
measure: death
timeFrame: 12 months
Secondary outcomes:
measure: right ventricle function
timeFrame: 12 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: MeshalkinRI
Study officials:
References: