louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06351618: Epidemiology of Injuries in the Professional Women's Swedish National IceHockey League Permitted to Body-Checking
Official title: Swedish Female Ice Hockey Injury Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sport Injury
Ice-Skates Accident
Sports Accident
Female Athlete Triad
Female
Keywords: women's health
Ice hockey
Elite sport
Injuries
Bodychecking
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 225
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Registered players in SDHL.

Brief summary: This research project can contribute to a deeper understanding of injury patterns among professional female ice-hockey players allowed to body check. An understanding of common injury types and mechanisms aids the clinician in diagnosis and management. This information can guide preventative strategies in the areas of education, coaching, rule enforcement, rule modifications, equipment improvement, and sportsmanship. Today, ice hockey is a sport associated with many severe injuries that not only causes suffering and lower quality of life for the athlete, but also costs society a lot of money. Reducing the number and severity of sport-related injuries is therefore of importance. Knowledge of the injury epidemiology of women's hockey could also contribute to better preventive training programs and other injury preventive actions in the sport. Currently, only a minority of all sports medicine research is made on female study participants (26). This research project has the possibility to gain more knowledge about the female athlete, not only applicable for elite hockey-players, but also for female athletes in different disciplines and in youth teams. Knowledge of factors associated with injury could also contribute to better injury preventive actions and highlight subgroups in extra need of future preventive interventions.


Eligibility criteria: Inclusion Criteria:

* minimum 16 years of age, registered player in the highest Swedish professional ice hockey league for women, SDHL

Exclusion Criteria:

* age under 16 years.

Primary outcomes:
measure: Injuries per 1000 training hours
timeFrame: 1 year
measure: Injuries per 1000 game hours
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: The Faculty of Medicine at Lund University
Study officials:
References:
Clinical trial NCT03034018: Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia
Official title: A Double-blind, Randomized, Placebo-controlled Study to Determine the Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia in Midlife Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Insomnia
Keywords: insomnia
hot flashes
menopause
suvorexant
belsomra
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri- and postmenopausal women who are experiencing sleep difficulties related to nighttime hot flashes.


Eligibility criteria: Inclusion Criteria:

* Peri- or postmenopausal women
* DSM-5 criteria for Insomnia disorder, with onset of symptoms attributed to hot flashes
* Some awakenings co-occur with a hot flash
* Score on the Insomnia Severity Index (ISI) measure ≥15
* Hot flashes present, including at night

Exclusion Criteria:

* Diagnosis of other primary sleep disorders
* Shift workers
* Current or expected use of hypnotic medications
* Current major depressive episode
* Lifetime history of bipolar disorder, psychosis, or other serious mental health problem
* Current alcohol/substance use disorder
* Obesity
* Renal or hepatic disease
* Pregnancy or breastfeeding
* Recent malignancy
* Recent surgery
* Neurological disorder or cardiovascular disease raising safety concerns
* Medical instability considered to interfere with study procedures
* Concomitant medications with drug interaction or co-administration concerns
* Contraindications or allergic responses to suvorexant
* Recent or planned travel across time zones
* Excessive coffee or cigarette use

Primary outcomes:
measure: Within-person Change in ISI Score
timeFrame: baseline and 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Hadine Joffe, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rahman SA, Nathan MD, Wiley A, Crawford S, Cohn AY, Harder JA, Grant LK, Erickson A, Srivastava A, McCormick K, Bertisch SM, Winkelman JW, Joffe H. A double-blind, randomized, placebo-controlled trial of suvorexant for the treatment of vasomotor symptom-associated insomnia disorder in midlife women. Sleep. 2022 Mar 14;45(3):zsac007. doi: 10.1093/sleep/zsac007.
Clinical trial NCT00432718: Saline Instillation Before Tracheal Suctioning and the Incidence of Ventilator Associated Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation
Critically Ill Patients
Keywords: Pneumonia
Ventilator Associated Pneumonia
Prevention
Lead sponsor: Hospital do Cancer, Sao Paulo
Sponsor class: OTHER
First posted: 2007-02-08
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Compare the incidence of ventilator associated pneumonia with or without tracheal isotonic saline instillation before tracheal suctioning


Eligibility criteria: Inclusion Criteria:

* Consecutive patients foreseen to receive mechanical ventilation for more than 72 hours

Exclusion Criteria:

* Previous mechanical ventilation in the last month
* Mechanical ventilation for more than 6 hours before arrival at ICU,
* Contraindication to bronchoscopy and
* Be expected to die or undergo withdrawal treatment within 48 hours-

Primary outcomes:
measure: incidence of ventilator associated pneumonia
Secondary outcomes:
measure: atelectasis
measure: tube occlusion
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: ICU Hospital do Câncer
state: SP
Study officials:
affiliation: Intensive Care Unit - Hospital do Câncer and University of Sao Paulo Medical School
name: Pedro Caruso, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06456918: ValidationTurkishVersionQualityofRecovery-15
Official title: Validation of the Turkish Version of the "Quality of Recovery 15 (QoR-15)" Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Abdominal Surgery
Patient-reported Outcome
Keywords: major abdominal surgery, outcome, QoR-15, validation
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 510 patients who met the inclusion criteria of being over age of 18 and had a planned elective major gastrointestinal surgery were included in the study.

Brief summary: The aim of this study was to perform a cross-cultural adaptation and psychometric evaluation of the Quality of Recovery 15 questionnaire in Turkey.

Detailed description: The QoR-15 was translated into Turkish through a rigorous process involving independent translations, consensus, back-translation, and review. The questionnaire was administered to patients undergoing elective major gastrointestinal surgery preoperatively and on postoperative days 1, 7, and 30. Reliability was assessed using Cronbach's α and intra-class correlation coefficient. Construct validity was evaluated through confirmatory factor analysis, and responsiveness was analyzed using Cohen's effect size and standardized response mean.

Eligibility criteria: Inclusion Criteria:

* being over age of 18 and had a planned elective major gastrointestinal surgery

Exclusion Criteria:

* under 18 years of age, had an alcohol or substance addiction problem, refused to participate in the study, had a previous major abdominal surgery

Primary outcomes:
measure: To validate the QoR-15
timeFrame: September 2019-September 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Mehmet Ali Koc
state: Altindag
Study officials:
affiliation: Ankara University
name: Mehmet A Koc, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00517218: This Study is Being Performed to Evaluate the Effect of Genasense on the Efficacy and the Safety of Rituximab/Fludarabine Combination Treatment in Previously Untreated Subjects With Chronic Lymphocyctic Leukemia(CLL)
Official title: A Randomized Phase 3 Study of Fludarabine and Rituximab With or Without Genasense® (Oblimersen Sodium) in Previously Untreated Subjects With Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Lymphocytic Leukemia
Keywords: Evaluate the Effect of Genasense on the Efficacy/Safety of Rituximab/Fludarabine Treatment in Untreated Subjects With Chronic Lymphocyctic Leukemia
Lead sponsor: Genta Incorporated
Sponsor class: INDUSTRY
First posted: 2007-08-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy and safety of combination treatment with Genasense, fludarabine, and rituximab versus combination treatment with fludarabine and rituximab in previously untreated subjects with CLL.


Eligibility criteria: Inclusion Criteria:

* Previously untreated subjects with intermediate-or high-risk CLL(modified Rai Stages I-IV)
* Measurable disease as primarily established by the National Cancer Institute-sponsored Working Group(NCI-WG) Guidelines for the diagnosis of CLL
* Requiring therapy for active disease, as primarily defined by the NCI-WG Guidelines
* Eastern Cooperative Oncology Group Performance Status \< 2
* Adequate organ function determined , 14 days prior to the first dose of study medication

Exclusion Criteria:

* Absolute Lymphocyte count \> 100,000/uL
* Prior chemotherapy or other therapy for CLL, including allogeneic transplant
* Less than 3 weeks from any prior major surgery at the time of informed consent
* Failure to recover from any serious adverse effect of surgery
* History of autoimmune hemolytic anemia or autoimmune thrombocytopenia
* Active serious infection requiring systemic anti-infective therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01454518: Local Infiltration Analgesia for Hip Arthroscopy
Official title: Effectiveness of Ultrasound Guided Hip Infiltration With Local Anesthetic Solution for Pain Control After Hip Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: hip arthroscopy
post operative analgesia
Lead sponsor: Trinity Health Of New England
Sponsor class: OTHER
First posted: 2011-10-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine if ultrasound guided infiltration of local anesthetic solution around the hip joint will provide effective pain control after hip arthroscopy.


Eligibility criteria: Inclusion Criteria:

* hip arthroscopy
* ages 18-80

Exclusion Criteria:

* history of neurological disease
* diabetes
* pregnancy
* neuropathy
* chronic narcotic use
* allergy to local anesthetic solution
* inability to give consent or cooperate with the study protocol

Primary outcomes:
measure: Post operative opioid consumption.
timeFrame: Within 24 hours after surgery
Secondary outcomes:
measure: Pain scores in recovery room.
timeFrame: Within 24 hours of the surgery
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Saint Francis Hospital and Medical Center
state: Connecticut
Study officials:
affiliation: Saint Francis Hospital
name: Sanjay Sinha, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01429818: Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients
Official title: Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients. Positron Emission Tomography Assessment(PET)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endothelial Dysfunction
Diabetes Mellitus
Keywords: Endothelial dysfunction
Diabetes mellitus
glimepiride
metformin
Lead sponsor: Laboratorios Silanes S.A. de C.V.
Sponsor class: INDUSTRY
First posted: 2011-09-07
Enrollment: 16
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 Purpose of this study was to evaluate the effect of the combination glimepiride/metformin over endothelial dysfunction (ED) in asymptomatic patients with type 2 diabetes mellitus (DM) using 13N-ammonia-positron emission tomography (PET).


Eligibility criteria: Inclusion Criteria:

* Both genders
* At least 18 years old
* Type 2 diabetes mellitus diagnosis
* Signed Informed Consent

Exclusion Criteria:

* History of smoking, hypertension, dyslipidemia, ischemic heart disease or autoimmune rheumatic diseases
* Pregnancy or lactation
* History of abuse and/or substance dependence within 6 months preceding the survey.
* History of glimepiride or metformin allergy

Primary outcomes:
measure: EDVI
timeFrame: 8 weeks
measure: MFR
timeFrame: 8 weeks
measure: %ΔMBF
timeFrame: 8 weeks
Secondary outcomes:
measure: Fasting glucose
timeFrame: 8 weeks
measure: Glycated hemoglobin
timeFrame: 8 weeks
measure: Adverse effects
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Unidad PET Ciclotrón. Facultad de Medicina. Universidad Nacional Autónoma de México
state: Distrito Federal
Study officials:
affiliation: Laboratorios Silanes S.A. de C.V.
name: Jorge González, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05221918: A Study to Compare CSF Flow Metrics Across Platforms
Official title: Comparison of CSF Flow Metrics Across MRI Platforms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include healthy young adults, ages 18-40 years.

Brief summary: The purpose of this research is to find out more about detecting movement of CSF (fluid around the brain) with MRI. Researchers are doing this research study to find out how measurements of CSF movement differ among MRI machines and how image quality is changed by reducing the scan time.


Eligibility criteria: Inclusion Criteria:

- A healthy volunteer will be defined as an otherwise healthy person who does not have a medical condition that affects brain function or have problems with concentration, memory, balance, or coordination.

Exclusion Criteria:

- Subjects with non-MRI compatible devices, required sedation (claustrophobia or unable to remain still for exam), or women who are pregnant will be excluded.

Primary outcomes:
measure: Comparison of flow metrics among scanners
timeFrame: February -December 2022
measure: Comparison of flow metrics between scans with and without parallel imaging
timeFrame: February -December 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Petrice Cogswell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04016818: Pilot Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution
Official title: Pilot Study of a Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is a research study of a novel, "breast-dedicated" positron emission tomography (PET) camera with 1 millimeter spatial resolution. The main goal of the study is for the personnel to understand practical and logistical issues with using the camera in the clinic

Detailed description: Primary Objective To obtain initial experience using the novel, breast-dedicated PET camera design in the breast imaging clinic.

Secondary Objectives To understand, given the 10-fold higher sensitivity of this novel camera, how low we can go with administered tracer dose, and, given the \>100-fold better volumetric spatial resolution, understand the achievable image quality.

Eligibility criteria: Inclusion Criteria:

* Biopsy-confirmed breast cancer measuring ≥ 5 mm on mammogram or ultrasound.
* Prior diagnostic imaging test(s) with another modality such as MRI, CT, or x-ray mammography (or other applicable imaging modalities) within 60 days prior to the study date.
* Documented written informed consent document.

Exclusion Criteria:

* 1. Additional condition, or extenuating circumstance that, in the opinion of the investigator, may interfere with study compliance.
* Known allergies to FDG
* Pregnant or nursing.

Primary outcomes:
measure: Image quality with the breast-dedicated PET camera
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Wendy B DeMartini
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02876718: Xarelto Evidence in Real Life of Patients' Preference and Satisfaction Study
Official title: Xarelto Evidence in Real Life of Patients Preference and Satisfaction Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2016-08-24
Enrollment: 253
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 300 patients will be included in this study. Participating centers are either primary care practices, internal medicine specialist practices or out-patient sites/out-patient clinics

Brief summary: The main objective of the study is to assess preferences of Non Valvular Atrial Fibrillation (NVAF) patients towards different options of an anticoagulation treatment.

Patient preferences for anticoagulant treatment attributes (convenience attributes only), based on a Discrete Choice Experiment(DCE) interview will be elicited and the impact of switching from Vitamin K Antagonist(VKA) to Xarelto® on Atrial Fibrilation(AF) patient treatment satisfaction will be documented, measured by score differences of the Anti-Clot Treatment Scale (ACTS) score in patients switching from VKA to Rivaroxaban.


Eligibility criteria: Inclusion Criteria:

* Female and male patients ≥ 20 years of age (legal age limit in Taiwan) with a confirmed diagnosis of AF (non-valvular).
* Treatment with VKA for at least 6 weeks.
* Decision to initiate treatment with Rivaroxaban has been made as per investigator's routine treatment practice.
* Written informed consent of the patient.
* Wilingness and capability to conduct two F2F interviews.

Exclusion Criteria:

* Contraindications to the use of Rivaroxaban as outlined in the local product information .
* Concomitant treatment with any other anticoagulants.
* Participation in another study (clinical intervention/observational) within the 3 months prior to enrollment.
* Patients participating in an investigational program with interventions outside of routine clinical practice.

Primary outcomes:
measure: Patient preferences for anticoagulant treatment attributes (utility values obtained in Logit/Probit estimates)
timeFrame: At 3 months
Secondary outcomes:
measure: Change of the Anti-clot treatment scale (ACTS) benefit and burden score from baseline (on VKA) to 3 months (on Xarelto)
timeFrame: At 0 month and at 3 months
measure: AF symptoms as measured by European Heart Rhythm Association (EHRA) symtoms (both severity and frequency)
timeFrame: At 3 months
measure: Reasons for switch from VKA to Xarelto
timeFrame: At 0 month
Other outcomes:
Locations:
city: Multiple Locations
country: Taiwan
facility: Many Locations
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: