louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05202444: The Use of Piezoelectric Surgery for Osteotomies
Official title: Evaluation of Using Piezoelectric Device Versus Conventional Saw for Osteotomy in Maxillary Orthognathic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillofacial, Osteotomy
Lead sponsor: Minia University
Sponsor class: OTHER
Collaborators: name: Dar Al Shifa Hospital
First posted: 2022-01-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Piezo-surgery was ﬁrst used in oral and maxillofacial surgery in 2001 by Vercellotti and colleagues to simplify maxillary sinus surgery by avoiding perforation of the schneiderian membrane. Later on ultrasonic bone cutting has been used in orthognathic procedures, extraction of impacted third molars , cyst enucleation, implant site preparation, temporomandibular join surgery , corticotomy-facilitated orthodontics, and head and neck oncological and reconstructive surgeries.


Eligibility criteria: Inclusion Criteria:

1. Age ranged from 18 to 35 years.
2. Patients were not suffering from systemic diseases that compromise wound or bone healing.
3. Patients indicated for leforte I or maxillary subapical osteotomy.
4. Patients agree the informed consent .

Exclusion Criteria:

1. Patients suffering from systemic disease that may affect bleeding or bone healing
2. Syndromicdentofacial deformity patients.
3. Patients were subjected to previous maxillary orthognathic surgery.

Primary outcomes:
measure: Intra-operative Bleeding
timeFrame: From begining of the surgery till the end
measure: Osteotomy Time
timeFrame: From begining of the surgery till the end
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Dentistry, Minia University
Study officials:
References:
Clinical trial NCT06338644: Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients.
Official title: Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hormone-receptor-positive Breast Cancer
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Metastatic Breast Cancer
Keywords: Metastatic breast Cancer, Palbociclib, Pharmacogenomic
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 100
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: Hormone receptor-positive HER2-negative metastatic breast cancer patients

Brief summary: Cyclin-dependent kinase (CDK) 4/6 inhibitors are a class of agents recently introduced in the clinic for the treatment of advanced hormone receptor-positive (HR+) and HER2-negative (HER2-) BC. Palbociclib, ribociclib and abemaciclib have all been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency among other regulatory bodies

Detailed description: Several factors are thought to influence the variability of treatment efficacy and toxicity, including organ function, comedications, hormonal status, body weight, age, comorbidities, etc. Among them, single nucleotide polymorphisms (SNPs) as rs1128503, rs2032583 are attracting huge interest to address the interindividual variability in drug response, whether in terms of efficacy or safety

Eligibility criteria: Inclusion Criteria:

* 1. Adult patients (≥18 years). 2. Confirmed diagnosis with MBC. 3. HR-positive/HER2-negative MBC as ascertained by immunohistochemistry (IHC) or fluorescence in situ hybridization in primary or metastatic tissue samples.

  4. Patients with primary or secondary resistance to endocrine therapy. 5. Patients with Eastern Cooperative Oncology Group (ECOG) 0 or 1. 6. Scheduled to receive Palbociclib in first- or second-line metastatic setting.

Exclusion Criteria:

1. Prior exposure to fulvestrant or everolimus.
2. Patients with uncontrolled brain metastases or symptomatic visceral spread who are at risk of life-threatening complications.
3. Patients refusing to sign the written informed consent.

Primary outcomes:
measure: 1-year Progression free survival (PFS)
timeFrame: 1 year
Secondary outcomes:
measure: Neutropenia
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02400944: Determinants of Bladder Cancer Recurrence Study (The DETER Study)
Official title: Determinants of Bladder Cancer Recurrence Study (The DETER Study)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bladder Cancer
Keywords: MSK Tobacco Cessation Program
smoking exposure
15-047
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2015-03-27
Enrollment: 600
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: MSKCC clinic

Brief summary: The purpose of this study is to learn how different lifestyle factors, such as cigarette smoking and body weight, change after a diagnosis of bladder cancer, and how they influence who gets a bladder cancer recurrence and who does not.


Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years old AND
* Histologically-confirmed non-muscle invasive bladder cancer (NMIBC)

Exclusion Criteria:

* Patients are ineligible for the study if they have/had:
* Histologically-confirmed NMIBC diagnosed \>36 months prior to enrollment
* Cystectomy prior to enrollment
* Any condition, which in the opinion of the primary MSK clinician or investigators precludes their ability to provide informed consent or comply with study procedures
* Non English-speaking

Primary outcomes:
measure: recurrence
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Helena Furburg-Barnes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02727244: The Association Between Pain Catastrophizing Scale Score and Postspinal Headache
Official title: Is There an Association Between Pain Catastrophizing Scale Score and Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Headache
Keywords: Pain Catastrophizing Scale
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women with pregnancy whose planned to undergo urgent or elective cesarean section

Brief summary: This study is aimed to elucidate the association between Pain Catastrophizing Scale Score and Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia.

Detailed description: This study is aimed to elucidate the association between Pain Catastrophizing Scale Score and Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia. Patients were asked to fill the questionnaire booklet including Pain Catastrophizing Scale, Beck Depression Inventory and Beck Anxiety Inventory before elective cesarean section in preoperative room in operating theater. In postoperative second and fourth day, patients will call by phone and be asked to have headache or any complaints. The intensity of headache will evaluate by using visual analog scale. Age, gender, and visual analog scale scores will be recorded.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists score of I, II, III
* without a history of cerebrovascular diseases
* without any presence of psychiatric diseases

Exclusion Criteria:

* severe liver, kidney and cardiovascular diseases
* peripheral arterial diseases
* a history of allergy to local anesthetics
* patients without cooperation
* not to participate in the study
* presence of neurologic or neuromuscular diseases

Primary outcomes:
measure: pain catastrophizing scale score
timeFrame: one time in one year
Secondary outcomes:
measure: Beck depression inventory
timeFrame: one time in one year
measure: beck anxiety inventory
timeFrame: one time in one year
measure: visual analog scale score
timeFrame: one time in one year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03834844: Meditation and Education That is Nurse Delivered for Symptom Management in Paroxysmal Atrial Fibrillation (PAF)
Official title: Mindfulness Meditation and Patient Education for Symptom Management in Individuals With Atrial Fibrillation(AF): Do They Need to Be Offered Together?
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Symptom Management
Quality of Life
Anxiety
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2 x 2 factorial design
Primary purpose: TREATMENT

Brief summary: The aim of this project is to determine whether the entire intervention (Mindfulness meditation, AF education, and weekly phone visits) that is nurse delivered to individuals with paroxysmal atrial fibrillation is more effective than a combination, single or no intervention in the reduction of overall AF symptoms, anxiety, and negative illness perception; or the improvement of quality of life (QOL) and functional status.


Eligibility criteria: Inclusion Criteria:

1. Individuals with Symptomatic Paroxysmal Atrial Fibrillation
2. A symptomatic episode of PAF within last 6 months
3. 18 years old or greater
4. Able to read and understand English
5. Able to participate in weekly phone calls
6. Able to attend two video visit/phone sessions that are 6 weeks apart

Exclusion Criteria:

1. Diagnosed with low cardiac function (NYHA Class IV)
2. Life expectancy of less than 6 months
3. Hospitalized in prior 3 months for illness other than PAF
4. Previously practiced mindfulness
5. Cognitive impairment

Primary outcomes:
measure: Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores
timeFrame: Baseline (Initial), Post-Intervention (6 weeks)
measure: Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores
timeFrame: Baseline (Initial), 6 month
measure: Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores
timeFrame: Baseline (Initial), 12 month
measure: Change from Baseline in AF Quality of Life Score
timeFrame: Baseline (Initial), Post-Intervention (6 weeks)
measure: Change from Baseline in AF Quality of Life Score
timeFrame: Baseline (Initial), 6 month
measure: Change from Baseline in AF Quality of Life Score
timeFrame: Baseline (Initial), 12 month
Secondary outcomes:
measure: Change from Baseline in Anxiety
timeFrame: Baseline (Initial), Post-Intervention (6 weeks)
measure: Change from Baseline in Anxiety
timeFrame: Baseline (Initial), 6 months
measure: Change from Baseline in Anxiety
timeFrame: Baseline (Initial), 12 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Health Care
state: California
Study officials:
affiliation: Clinician and research scientist
name: Linda Ottoboni, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02901444: Observational Study on Changing the Quality of Life in Daily Life Activities After Clinical Approach Positioning the Wheelchair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mobility Limitation
Wheelchairs
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Personns which are in wheelchair since more than 6 months

Brief summary: Stemming from the common practice of attribution of the technical helps in the posture in Canada, the multidisciplinary approach of positioning develops in France for more than 10 years old.

To date, no observatory study was led to estimate the impact of such consultation in daily activities, an essential objective conditioning the observance and the acceptance of assistive devices. This study wants to estimate the impact through modification of WHOM scale.


Eligibility criteria: Inclusion Criteria:

* persons which are in wheelchair since more than 6 months,
* no recent medical decompensation (\<1 mois)

Exclusion Criteria:

* recent medical decompensation

Primary outcomes:
measure: WHOM scale (before consultation, after consultation)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01965444: A Test of the Investigational SEM Scanner
Official title: An Investigational, Non-significant Risk Study to Collect Data Needed to Analyze Readings Given by the SEM Scanner Point of Care 200 Series (SEM POC 200) and Its Ability to Detect Sub Epidermal Moisture.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pressure Ulcers
Keywords: Sub-epidermal moisture
Pressure Ulcers
Lead sponsor: Bruin Biometrics, LLC
Sponsor class: INDUSTRY
First posted: 2013-10-18
Enrollment: 50
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: Intensive Care Units

Brief summary: The objective of this study is to establish required data for SEM Scanner analysis of the readings given by the SEM Scanner in the target patient population.. In order to better understand the data this non-invasive scanner provides a collection of data/readings is required to be collected in a certain population. This will help with clinical interpretation of the numbers and readings this device will provide.


Eligibility criteria: Inclusion Criteria:

* Subjects are 18 years of age or older.
* Subject or health care proxy is willing and able to provide informed consent for enrollment.
* Subject is agreeable to having skin assessments, blanchability tests, and SEM Scanner readings performed daily at all anatomical sites for a duration of five (5) days, with photography as needed.
* Subject is admitted to an intensive Care Unit (ICU) and has an anticipated ICU course of 48 hours or greater.
* Subject is not Comfort Measures Only (CMO).
* Subject is anticipated to be bedridden for ore than 6 hours per day.
* All four (4) of the subject's anatomical sites in question (sternum, sacrum, left heel and right heel) are accessible for scanning (e.g., no cast or medical device present such that heels are not accessible).

Exclusion Criteria:

* Subject has broken skin or scar tissue at the sternum, sacrum, left heel or right heel.
* Subjects for whom the physical act of performing the inspections and measurements required in this study are contra-indicated, as determined by the principal investigator or attending physician.
* Subjects or legal representatives who are unable to understand the aims and objectives of the trial.
* Presence of any condition(s) which seriously compromise(s) the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
* Subject is pregnant.
* Subject is incarcerated.

Primary outcomes:
measure: Descriptive statistic measurements
timeFrame: 5 day study period
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: UMass Memorial Health
name: Timothy Emhoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00694044: Evaluation of Varenicline Safety, Tolerability, Pharmacokinetics and Pro-Cognitive Effects in Healthy Elderly Non-Smoking Subjects
Official title: A Randomized, Investigator and Subject Blind, Sponsor Open Parallel Group Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pro-Cognitive Effects of Varenicline, Under Various Titration Schemes, in Healthy Elderly Non-Smoking Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Non-Smoking
Keywords: Safety, Tolerability, Pharmacokinetics, Cognition
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-06-10
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 1. Characterize the tolerability and safety of repeated doses of varenicline in healthy non-smoking elderly subjects.
2. Describe the steady state pharmacokinetics of varenicline in healthy non-smoking elderly subjects.
3. Evaluate the potential effects of repeat doses of varenicline on cognition in healtly non-smoking elderly subjects.


Eligibility criteria: Inclusion Criteria:

Healthy, Elderly (65-85 years inclusive), Non-smoker

Exclusion Criteria:

Creatinine Clearnace \< 30 ml/min, Evidence or history of clinically significant, unstable diseases

Primary outcomes:
measure: Tolerability and safety (adverse events, electrocardiogram, vital signs, clinical safety labs, self reported nausea visual analogue scales)
timeFrame: 21 days
measure: Steady state pharmacokinetics
timeFrame: 21 days
measure: Effects on cognition (computerized battery of cognitive tests)
timeFrame: 21 days
Secondary outcomes:
measure: No secondary outcomes.
timeFrame: Time frame n/a
Other outcomes:
Locations:
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01576744: Serum Biomarker HE4 During IVF Treatment
Official title: Serum Concentration of HE4, a New Marker for Ovarian Cancer, Changes Little Throughout IVF Stimulation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: IVF Treatment
Human Epididymal Secretory Protein E4
Keywords: HE4
IVF
Biomarker
Ovarian cancer
Infertility
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2012-04-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 27
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Finnish caucasian women being treated for infertility by in vitro-fertilization

Brief summary: Human epididymal secretory protein 4 (HE4) is a new biomarker for ovarian cancer. The effect of IVF stimulation will be evaluated in order to see whether severe hormonal changes in the gonadotrophin and steroid status affect the serum levels of this marker. Findings will be compared to serum concentrations of CA-125, which is currently the most often used marker for ovarian cancer.

The intention is to determine the serum concentration of HE4 and CA-125 in serial samples in 20 women undergoing IVF stimulation. Samples will be taken following GnRH agonist suppression, 2-3 times during FSH stimulation, at ovum pick up and two weeks following embryo transfer at the time of the hCG-test. The ovarian follicle count and the serum estradiol concentrations are recorded throughout the treatment. The serum biomarker HE4 is expected to ba a stable marker, which does not respond significantly to hormonal stimulation.


Eligibility criteria: Inclusion Criteria:

* infertility treated by IVF

Exclusion Criteria:

* pelvic tumor
* overweight (BMI over 35)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Department of Obstetrics and Gynecology, Turku University Hospital
Study officials:
affiliation: Department of Obstetrics and Gynecology, Turku University Hospital
name: Antti H Perheentupa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03186144: Clinical and Molecular Study of CHARGE Syndrom
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Development Abnormalies
Inclusion on Clinical Criteria of the Syndrome
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 141
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: 1. Clinical description of a French cohort of patients with CHARGE syndrome.
2. Search any phenotype-genotype correlation in typical, atypical or incomplete form of the syndrome
3. Using Next generation Sequencing, try to identify other genes involved in this syndrome, as the CHD7 gene is involved in only 40-60% of cases


Eligibility criteria: Inclusion Criteria: Clinical criteria

Major criteria:

* Ocular coloboma
* Chonamal atresia and/or cleft palate
* Semi-CircularCanals hypoplasia

Minor criteria:

* Cranial nerves
* Hypothalamic-pituitary deficiency
* Internal or external ear malformation
* Cardiac, esophageal malformations
* Intellectual Deficiency

Diagnosis criteria:

* Typical CHARGE: 3 major criteria or 2 major + 2 minor
* Partial CHARGE: 2 major + 1 minor
* Atypical CHARGE: 2 major without minor or 1 major + 2 minor

Exclusion Criteria:

* Absent consentment for genetic analysis

Primary outcomes:
measure: Description Clinical and molecular analysis of a French cohort CHARGE
timeFrame: 12 month
measure: Execution of the socio-adaptive scale, parental scale
timeFrame: 12 month
measure: Rate of mutations of CHD7 and / or type of mutations
timeFrame: 12 month
measure: analysis CHD7 gene from the patient's DNA
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: French Referent centers for developement abnomalies
Study officials:
References: