louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00381368: Safety and Efficacy Study of Intravenous Loading Dose of Ibandronate in Breast Cancer Patients
Official title: Phase II Open Label Study to Establish the Safety and Efficacy of Intravenous Loading Dose of Ibandronate 6 mg in 3 Consecutive Days in Breast Cancer Patients With Skeletal Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
skeletal metastases
bisphosphonate therapy
Breast cancer with painful skeletal metastases
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2006-09-27
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the efficacy and safety of a three time repeated loading dose of intravenous ibandronate (ibandronic acid), 6 mg, in breast cancer patients with painful skeletal metastases.

Detailed description: Painful skeletal metastases are a common site of advanced disease. For instance, in breast cancer, and despite cancer treatments (radiotherapy, cytotoxic treatment and adequate treatment of pain), the patients often need additional treatments that may relieve their symptoms. Bisphosphonates, such as ibandronic acid, have in pilot studies shown a significant decrease in pain scores, both after loading dose and after long-term treatment. In this study the safety and efficacy of an intravenous loading dose of three times 6 mg ibandronate during three consecutive days in breast cancer patients with painful skeletal metastases will be studied.

Eligibility criteria: Inclusion Criteria:

* Breast cancer with presence of bone metastases
* Pain score over 4 on the VAS

Exclusion Criteria:

* Patients with pathological fractures or medulla compression or neuropathic pain
* Patients with infection or corticosteroid treatment
* Pregnant or lactating patients

Primary outcomes:
measure: Worst and average pain in movement and rest on the visual analogue scale (VAS) before the first dose, on days 2, 3, 7 and on day 28
measure: Analgesic consumption during the same period will additionally be assessed
Secondary outcomes:
measure: Bone markers: serum 1CTP, serum P1NP, serum NTX on day 1 before dosing, and on days 7 and 28
measure: World Health Organization (WHO) performance status
measure: Safety: serum cystatin C and serum creatinine, and reporting of adverse events
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Dept of Oncology, Helsinki University Central Hospital
city: Oulu
country: Finland
facility: Dept of Oncology, Oulu University Hospital
city: Tampere
country: Finland
facility: Dept of Oncology, Tampere University Hospital
Study officials:
affiliation: Dept of Oncology, Turku University Hospital, Finland
name: Outi Paija, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03766646: Preoxygenation With Optiflow™ - the Effect of Speech on Lung Oxygenation.
Official title: Preoxygenation With High Flow Nasal Oxygenation Using Optiflow - Does Speech Have an Effect on The End Tidal Oxygen Achieved When Compared to Closed Mouth Nasal Breathing?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unrecognized Condition
Keywords: Optiflow
High Flow Nasal Oxygen
Preoxygenation
Speech
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were assigned to either the 'Speech' arm or 'Non-speech' arm of the study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: If a patient speaks during the process of preoxygenation with high-flow nasal oxygen via the Optiflow™ system, is the efficacy reduced as measured by end-tidal lung oxygen content?

Detailed description: This is a randomised controlled trial on 34 patients undergoing routine elective surgery at the Princess Anne Hospital, Southampton. The study will take place from September 2018 to January 2019 and involve preoxygenating all participants for three minutes using the Optiflow™ device. During this time, participants will be instructed to either read aloud a standardised text or to breathe through their nose with a closed mouth. At the end of 3 minutes, the primary outcome, ETO2, will be measured and recorded.

Eligibility criteria: Inclusion Criteria:

* BMI 18-35, ASA category 1 or 2

Exclusion Criteria:

* Inability to read/ follow instructions, Heavily sedated

Primary outcomes:
measure: End Tidal Oxygen Fraction
timeFrame: At the end of 3 minutes preoxygenation
Secondary outcomes:
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
state: Hants
Study officials:
affiliation: Unvistery Hospital Southampton
name: Patrick Butler
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01054846: Impact of Helmet Use in Preschool Children
Official title: The Impact of Helmet Use in Preschool Children From Low-income Families in Northeastern Indiana
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Injuries
Facial Injuries
Keywords: Bicycle helmet
Lead sponsor: Parkview Health
Sponsor class: OTHER
First posted: 2010-01-22
Enrollment: 609
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: * To test the hypothesis if provision of helmet education and free helmet distribution will significantly increase helmet use in preschool children of low-income families compared to those children receiving helmet education without free helmet distribution;
* To test the hypothesis if helmet users in preschool children will significantly reduce head and facial injuries compared to those non-helmet users

Detailed description: Current literature review shows that there were no definite prospective research studies that indicate the effectiveness of helmet promotion and wearing in injury prevention/reduction particularly to head and facial injuries among preschool children of low-income families.

The magnitude and seriousness of the injury problem in these children in the community could be high. Many injuries may occur that are not treated in emergency departments. Even the occurrence of a minor injury in the face is undesirable. These ages are learning periods to ride, are liable to fall, and are prone to injuries by using, not only, bicycles but also tricycles, scooters, roller skates/roller blades and other riding toys (vehicles).

Eligibility criteria: Inclusion Criteria:

* Age 3-5 year olds and their siblings, registered at the Community Action of Northeast Indiana (CANI) Head Start Program
* The child must possess a bicycle or a riding toy to ride
* The child's caregiver speaks English or Spanish

Exclusion Criteria:

* Age less than two or greater than 5-year olds
* 3-5 year old children that do not own a bicycle or a riding toy to ride
* The child's caregiver does not speak English or Spanish.

Primary outcomes:
measure: Percentage of Participants Wearing Helmet
timeFrame: Baseline (Survey 1) and 5 months (Survey 2)
Secondary outcomes:
measure: Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners
timeFrame: 5 months
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Community Action of Northeast Indiana (CANI) Inc - Head Start
state: Indiana
Study officials:
affiliation: Parkview Hospital Trauma Center
name: Mary O Aaland, MD, FACS
role: STUDY_DIRECTOR
affiliation: Parkview Hospital Trauma Center
name: Thein H Zhu, MBBS, FACE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhu TH; Aaland MO; Kerrigan C; Schiebel R; Henry H; Hollister L. Preventable head and facial injuries by providing free bicycle helmets and education to preschool children in a head start program. Health 2011 3(11):689-97
Clinical trial NCT05594446: Morphometric Study of the Legs and Feet of Diabetic Patients in Order to Collect Data Intended to be Used to Measure by Dynamometry the Pressures Exerted by Several Medical Compression Socks at the Level of the Forefoot
Official title: Morphometric Study of the Legs and Feet of Diabetic Patients in Order to Collect Data Intended to be Used to Measure by Dynamometry the Pressures Exerted by Several Medical Compression Socks at the Level of the Forefoot
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: diabetes
compression stockings
Lead sponsor: Sigvaris France
Sponsor class: INDUSTRY
Collaborators: name: Clin-Experts
First posted: 2022-10-26
Enrollment: 89
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 recruitment of participants will be done within the framework of the usual consultation of the participating doctor, among the population meeting the inclusion criteria.

Brief summary: The aim of the study is to collect morphometric data of legs and feet in diabetic patients in order to model in the laboratory the pressures exerted by compression stockings on different areas of the foot


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes over the age of 18
* Patients with diabetes of any type, balanced or not, with or without a history of mal perforating
* Giving their oral agreement to participate after information

Exclusion Criteria:

* Patients seen in an emergency
* Patient with lower limb amputee (even partial)
* Patients with a foot wound, whatever the etiology of the wound
* Presence of lymphedema
* History of foot trauma with sequelae

Primary outcomes:
measure: Collection of anthropometric measurements of the foot : Ankle circumference at thinnest point (cm)
timeFrame: 3 minutes
measure: Collection of anthropometric measurements of the foot : Popliteal heel height (cm)
timeFrame: 3 minutes
measure: Collection of anthropometric measurements of the foot : Circumference of the calf at the strongest point (cm)
timeFrame: 3 minutes
measure: Collection of anthropometric measurements of the foot : Circumference of the forefoot at the level of the metatarsal heads (cm)
timeFrame: 3 minutes
measure: Collection of anthropometric measurements of the foot : Radius of curvature estimated by a template, of the head of the first metatarsus (cm)
timeFrame: 3 minutes
measure: Collection of anthropometric measurements of the foot : Radius of curvature estimated by a template, of the head of the last metatarsus (cm)
timeFrame: 3 minutes
measure: Collection of anthropometric measurements of the foot : European shoe size
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Rastel Didier
Study officials:
affiliation: SELARL PHILANGIO
name: Didier RASTEL, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02613546: THE INFLUENCE OF COGNITIVE BEHAVIORAL THERAPY IN SEXUAL DYSFUNCTION FEMALE: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sexual Dysfunctions
Keywords: cognitive-behavioral psychotherapy
Sexual Dysfunctions
Women
Lead sponsor: Centro de Atenção ao Assoalho Pélvico
Sponsor class: OTHER
First posted: 2015-11-24
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research is a randomized clinical trial aims to evaluate the influence of cognitive-behavioral psychotherapy (CBT) on quality of life and sexual function of patients with sexual dysfunction. The notion of sexual health for the World Health Organization exceeds the concept of sickness absence, having a subjective well-being of significance in the spheres of self-concept, self-image, interpersonal relationships and sense of self worth. Furthermore, sexual satisfaction and relationship quality of life is also evidenced in many studies. CBT is a brief and focal psychotherapy with proven efficacy in several mental disorders, improving health and quality of life of the treated populations. However, they did not find clinical trials that showed the effectiveness of CBT in Sexual Dysfunctions. This study aims to then fill this gap by evaluating the relationship from the use of techniques of CBT.


Eligibility criteria: Inclusion Criteria:

* Women aged 18-59 years;
* FSFI less than or equal to 26.

Exclusion Criteria:

* Scores of Beck Scales - moderate or severe;
* Prescribing hormone therapy after starting the group.

Primary outcomes:
measure: Score Function Sexual
timeFrame: one week
Secondary outcomes:
measure: Quality of Life Scale Questionary
timeFrame: one week
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Centro de Atenção ao Assoalho Pelvico
state: Ba
Study officials:
affiliation: Centro de Atenção ao Assoalho Pélvico - BAHIANA
name: Patricia V Lordelo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000446: Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder
Official title: Sertraline Treatment in Comorbid Post-Traumatic Stress Disorder and Alcoholism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholism
Post-Traumatic Stress Disorder
Lead sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sponsor class: NIH
First posted: 1999-11-03
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This study will investigate the use of sertraline (Zoloft) to decrease alcohol consumption and crime-related post-traumatic stress disorder in those individuals with both disorders. This will be a 12-week, placebo-controlled, double-blind outpatient trial.

All subjects will receive cognitive behavioral therapy in addition to a placebo or sertraline. Comprehensive evaluation will be done at study entry; treatment termination; and 6, 9, and 12 months after study entry.


Eligibility criteria: Inclusion Criteria:

* Meets criteria for alcohol abuse or dependence and post-traumatic stress disorder.
* Laboratory tests for blood and urinalysis must be within normal limits.
* Must be clearly motivated to obtain benefit from treatment and keep appointments for study visits and therapy sessions.
* Females who use an acceptable method of birth control, are sterilized, or are at least 2 years post-menopausal.

Exclusion Criteria:

* Have a diagnosis of schizophrenia, bipolar affective disorder, dissociative identity disorder, eating disorder, substance dependence in the last 60 days.
* Currently suicidal.
* Medical reasons not to receive drug therapy.
* Allergy or hypersensitivity to selective serotonin inhibitor antidepressants.
* Significant hematological, endocrine, cardiovascular, renal, hepatic, neurological, or gastrointestinal disease.
* Liver function test greater than 2 times the normal level
* Require ongoing therapy with another psychoactive drug during the study period.
* Females who are pregnant or lactating.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Department of Psychiatry and Behavioral Science, Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT05039346: Quality of Life and Patient Needs in Advanced High Grade Gliomas
Official title: Quality of Life and Patient Needs in Advanced High Grade Gliomas - A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Brain Tumor
Glioblastoma
Glioma
Anaplastic Astrocytoma
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2021-09-09
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients must have been diagnosed with a high grade brain tumor and must show signs of clinical progression. Patients who have failed 3rd line chemotherapy regimen and who require at least occasional assistance are invited to participate.

Brief summary: There is limited knowledge regarding the quality of life and needs of patients with advanced high grade gliomas, especially during the end of life. By doing this research, we are able to assess caregiver and patient symptoms and needs during the end of life phase of patients with brain tumors.

Detailed description: Purpose: This is a pilot study to prospectively assess the symptoms and quality of life of patients and with advanced high grade glioma and their care takers.

Specific Aims: The aim of this study is to investigate the symptoms of patients with advanced high grade glioma. Patients who failed 3rd line chemotherapy and who require at least occasional assistance will be prospectively followed and their symptoms will be prospectively assessed. Patient's caregiver will be interviewed following the death of the patient to assess clinical symptoms in the last weeks of life and around the time of death.

Methods: Patients will undergo clinical symptom assessment via questionnaire. Patients will be followed by regular semi-structured phone interviews.

Should a patient pass, four weeks following this, the patient's care giver will be interviewed.

Eligibility criteria: Inclusion Criteria:

* Age \>18
* Tissue proven diagnosis of a high grade brain tumor
* Disease progression by MRI
* Therapy resistant tumor to 2nd line chemotherapy
* Karnofsky Performance Scale (KPS) score of 60 or less
* Patient will need to assign caregiver

Exclusion Criteria:

* None

Primary outcomes:
measure: Quality of life and end of life symptoms in brain tumor patients
timeFrame: 12 months
measure: Examination
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Henry Ford Health System
name: Tobias Walbert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05387746: Integrative Self-care Approaches for HCP Wellbeing
Official title: Caring Science, Mindful Practice™ and Reiki: Integrative Self-care Approaches to Promote Interprofessional Healthcare Provider Wellbeing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Professional
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Weil Foundation
First posted: 2022-05-24
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this pilot study is to assess the impact of a hospital-based integrative self-care program (e.g., a. Reiki and b. Caring Science and Mindful Practice \[CSMP\] course) for interprofessional staff including nurses, physicians and/or medical residents, physical therapists, as well as other healthcare providers on their wellbeing.

Detailed description: The primary research procedures are:

* Participants will complete an online pre-training survey via REDCap, including a demographic questionnaire, and questions related to Physical Function, Depression, Anxiety, Fatigue, Sleep Disturbance, Social Roles/Activities, Resilience, Burnout, COVID-19 Experience, Caring Science, and Reiki Knowledge and Application.
* Participants will participate in the 4-week (virtual) CSMP and (in-person) Reiki Training course.
* Participants will complete the online post-training survey with the same questions included in the pre-training survey.
* Data analysis will be conducted by the research team using descriptive statistics, bivariate analysis, and multivariate linear/logistic regression analysis to assess for relationships between the Reiki and CSMP training and HCP wellbeing.

The research team will enroll up to 20 participants comprising of interprofessional staff including nurses, physicians and/or medical residents, physical therapists, as well as other healthcare providers.

All parts of the protocol will be conducted at CSMC.

Eligibility criteria: Inclusion Criteria:

* Healthcare provider must:

  * Be 18 years or older
  * Be full-time employee of a CSMC hospital/clinic
  * MDs/DOs must have admitting privileges to a hospital and/or have private practice/ or be a current medical resident enrolled in a Cedars Sinai Medical Residency Program
  * Provide direct patient care in hospital and/or clinic
  * Consent to participating in the study

Exclusion Criteria:

* Healthcare provider who do not meet all the inclusion criteria and/or reports:

  * They do not provide direct patient care
  * Do not consent to participating in the study

Primary outcomes:
measure: Changes in perception of wellbeing
timeFrame: baseline, 30 days post, and 60 days post-training
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Linda Kim
role: PRINCIPAL_INVESTIGATOR
References: