louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05628389: Phone Enabled Implementation of Cessation Support
Official title: Phone Enabled Implementation of Cessation Support
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-11-28
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The tobacco use burden in Lebanon is exceptionally high: 35% of adults are current cigarette smokers and 39% are current waterpipe smokers. Although the World Health Organization endorses evidence-based interventions for population-level tobacco dependence treatment, recommended treatments are not integrated as a routine part of primary care in Lebanon, as is the case in other low-resource settings. The objective of this proposal is to evaluate the comparative effectiveness of promising multi-component interventions for implementing evidence-based cessation treatment in Lebanon's national system of primary health care centers.

Detailed description: The research team will conduct a group-randomized trial comparing three arms: 1) Ask about tobacco use, advise to quit, assist with brief counseling (AAA) as standard care; 2) Ask, advise, connect to phone-based counseling (AAC); and 3) AAC+ Nicotine Replacement Therapy (NRT). Our central hypothesis is that connecting patients to phone-based counseling with cessation medication is the most effective alternative. The hybrid design is informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework which emphasizes key steps and multilevel factors to optimize implementation success. The following specific aims will be pursued: 1) adapt and tailor an existing smoking cessation program to deliver phone-based counseling to smokers in Lebanon; 2) test the effectiveness and cost-effectiveness of a referral-based program that delivers smoking cessation services to primary care patients; and 3) identify the multilevel determinants of implementation and sustainability using mixed methods.

Eligibility criteria: Inclusion Criteria:

* Age 18+
* A current daily cigarette smoker and/or a regular waterpipe smoker (smokes at least 1-2 times/week).
* Not pregnant
* Reachable by phone
* Interested in quitting
* Lives in Greater Beirut Area

Exclusion Criteria:

* Patients who use other tobacco products including vape exclusively.
* Any patient below 18 years old.
* Cigarette smokers who do not smoke on daily basis.
* Waterpipe smokers who smoke less than once/weekly

Primary outcomes:
measure: 7-day smoking abstinence
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
measure: Self-reported abstinence
timeFrame: 1, 3, 6 months
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
affiliation: University of Florida
name: Ramzi Salloum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05616689: Bundled Hyperpolypharmacy Deprescribing
Official title: Bundled Hyperpolypharmacy Deprescribing: Implementation and Evaluation of a System-wide Quality Improvement Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polypharmacy
Keywords: deprescribing
polypharmacy
drug safety
randomized controlled trial
pharmacist
shared decision making
optimal prescribing
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 2471
Sex: ALL
Minimum age (years): 76
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Older patients using many prescription drugs (hyperpolypharmacy) may be at increased risk of adverse drug effects. This randomized controlled trial tested the effectiveness and safety of a quality intervention intended to reduce hyperpolypharmacy. The study was set at Kaiser Permanente Northern California, an integrated health system with multiple pre-existing deprescribing workflows. Eligible patients were aged ≥76 years using ≥10 prescription medications. The intervention included physician-pharmacist collaborative drug therapy management, standard-of-care practice recommendations, shared decision-making, and deprescribing protocols administered by telephone over multiple cycles for a maximum of 180 days after allocation. A priori primary effectiveness endpoints included change in the number of medications and in the prevalence of geriatric syndrome from 181-365 days after allocation. Second endpoints included utilization and adverse drug withdrawal effects. Information was obtained from the electronic health record.


Eligibility criteria: Inclusion Criteria:

* Kaiser Permanente patients
* Age ≥76 years
* ≥10 drugs (excluding topicals) where

  * drug filled ≥2 times in the past year and
  * drug last filled \< 180 days ago

Exclusion Criteria:

* less than 12 months preceding enrollment at Kaiser Permanente
* no primary care practitioner assigned
* on dialysis
* history of heart, liver, lung, breast, or bone marrow transplant
* in hospice
* under active treatment for cancer during the past 12 months
* has received an intervention through the Pharmacy Targeted Deprescribing Program in the preceding year.

Primary outcomes:
measure: Change in prevalence of geriatric syndrome
timeFrame: Difference between (days 181-365 after randomization) and (180 days before randomization)
measure: Change in number of medications
timeFrame: Difference between (days 181-365 after randomization) and (180 days before randomization)
Secondary outcomes:
measure: Utilization
timeFrame: Difference between (days 181-365 after randomization) and (180 days before randomization)
Other outcomes:
measure: Adverse drug withdrawal effects
timeFrame: Difference between (days 181-365 after randomization) and (180 days before randomization)
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Division of Research
state: California
Study officials:
affiliation: Kaiser Permanente
name: Lisa Herrinton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01294189: Advance Directives and End-of-life Decision Making in Intensive Care Medicine in Germany
Official title: The Impact of Instituting a Law for Advance Directives on End-of-life Decision Making in Intensive Care Medicine in Germany
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Death
Keywords: end-of-life decisions, critical care, advance directive
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2011-02-11
Enrollment: 224
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All intensive care department patients (MAN101i and MAN103i Charité Berlin) will be enrolled in the study

Brief summary: Description of the decision making process as well as the practices of end of life care in an ICU of a German university hospital during the period when changes of German legislation occurred.

Detailed description: Most patients on the intensive care unit (ICU) die after an end-of-life decision (EOLD) has been made (Sprung et al. 2003). On September 1st 2009 the "advance-directives-law" was inured in Germany considering a written advance directive of an adult binding for physicians and the patient´s surrogate decision makers if it fits into the medical context (BGBL 2009). There is a lack of data describing the process and the factors associated with end-of-life-decisions in ICUs in Germany in detail.

The purpose of this observational study is to describe the decision making process as well as the practices of end of life care in an ICU of a German university hospital during a period when changes of German legislation occurred.

Eligibility criteria: Inclusion Criteria:

* All patients admitted to the ICU
* All patients discharged death from the ICU

Exclusion Criteria:

* All patients discharged alive from the ICU

Primary outcomes:
measure: decision makers of end-of-life decisions
timeFrame: 08/2008 - 09/2010
Secondary outcomes:
measure: influence of the new German advance directives law on end-of-life decisions
timeFrame: 08/2008 - 09/2010
measure: the process of end-of-life decisions on a German intensive care unit
timeFrame: 08/2008 - 09/2010
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte
Study officials:
affiliation: Charite University, Berlin, Germany
name: Jan-Peter Braun, MD
role: STUDY_DIRECTOR
References:
citation: Graw JA, Spies CD, Wernecke KD, Braun JP. Managing end-of-life decision making in intensive care medicine--a perspective from Charite Hospital, Germany. PLoS One. 2012;7(10):e46446. doi: 10.1371/journal.pone.0046446. Epub 2012 Oct 1.
Clinical trial NCT06981689: Association of Breast Reconstruction Method With Long-term Risk of Psychiatric Disorders
Official title: Association of Breast Reconstruction Method With Long-term Risk of Psychiatric Disorders: A Target Trial Emulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: autologous reconstruction
implant-based reconstruction
psychiatric disorders
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 24930
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: The study included newly diagnosed female breast cancer patients who underwent total mastectomy followed by breast reconstruction classified into two types using ICD-10 procedure codes: autologous tissue reconstructions were coded from N7140 to N7147 and implant-based reconstructions were coded from N7148 to N7151 Exclusions applied to males, individuals who underwent reconstruction prior to mastectomy, and those diagnosed with psychiatric disorders within one year prior to surgery

Brief summary: Female breast cancer patients who underwent total mastectomy followed by breast reconstruction

Detailed description: Female breast cancer patients who underwent total mastectomy followed by breast reconstruction

Eligibility criteria: Inclusion Criteria:

* The study included newly diagnosed female breast cancer patients who underwent total mastectomy

Exclusion Criteria:

* individuals who underwent reconstruction prior to mastectomy
* those diagnosed with psychiatric disorders within one year prior to surgery

Primary outcomes:
measure: Psychiatric disorders
timeFrame: 1 year, 5 year and 9 year since surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06339489: The Bone Metabolism Characteristics of Premature Ovarian Insufficiency
Official title: Explore the Bone Metabolism Characteristics of Premature Ovarian Insufficiency
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Premature Ovarian Insufficiency
Bone Diseases, Metabolic
Bone Mineral Density
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: females with premature ovarian insufficiency

Brief summary: Explore the bone metabolism characteristics of premature ovarian insufficiency.

Detailed description: Explore the bone metabolism characteristics of premature ovarian insufficiency, indexes includes serum levels of TRACP-5b and BALP, BMD values of lumbar spine L1-L4, left and right hip, left and right femoral neck et.al.

Eligibility criteria: Inclusion Criteria:

Patients diagnosed by Western medicine with premature ovarian insufficiency. 18 ≤ patients' age ≤ 39 years;. Patients who voluntarily participate in this study, sign an informed consent form.

Exclusion Criteria:

Patients with congenital gonadal dysplasia or a family history similar to "early menopause".

POI patients with acquired organic lesions or ovarian surgery. Patients who have taken Western or herbal medicine artificial cycle therapy or other endocrine therapy in the past three months.

Patients with serious primary diseases and mental disorders such as cardiovascular and cerebrovascular, liver, kidney and hematopoietic system.

Patients who are breastfeeding or pregnant.

Primary outcomes:
measure: tartrate resistant acid phosphatase-5b, TRACP-5b
timeFrame: On the 2~4th day of menstruation (amenorrhea patients are collected when enrolled)
Secondary outcomes:
measure: bone specific alkaline phosphatase, BALP
timeFrame: On the 2~4th day of menstruation (amenorrhea patients are collected when enrolled)
measure: bone mineral density, BMD
timeFrame: On the 2~4th day of menstruation (amenorrhea patients are collected when enrolled)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital, Beijing University of Chinese Medicine
Study officials:
References:
Clinical trial NCT01275989: Ear Acupuncture Effectiveness In Reducing The Signs And Symptoms Of Stress And Anxiety
Official title: EAR ACUPUNCTURE EFFECTIVENESS IN REDUCING THE SIGNS AND SYMPTOMS OF STRESS AND ANXIETY
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Inclusion Criteria:
Voluntary Participation in the Study With Available Time for Submission to the Sessions, Which Occur Over Two Months.
Have a Score of Stress Medium, High or Very High in the LSS Questionnaire, Completion of the STAI and General Form.
Exclusion Criteria:
Pregnant Students.
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Santander
First posted: 2011-01-13
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized Controlled Trial found that levels of stress and anxiety of students ITIO, Ear and effective in reducing these levels. The LSS questionnaire and IDATE state were applied before, two months and two and a half months after the start of the applications, the STAI trait was applied once prior to the sessions. The sample comprised 56 individuals who had higher levels of stress above the average LSS 100 students who answered the questionnaires. Participants were divided randomly into three groups: control group with 15 patients without care, intervention group with 20 individuals using specific points for treatment and Group Sham at 21 points using individuals without indication for treatment of anxiety and stress. The results showed that the sham points decreased anxiety levels of participants.

Detailed description: After checking the levels of stress and anxiety of students and workers from a school of massage and acupuncture concluded that auricular acupuncture in this study had significant results in reducing anxiety levels with the use of points and Ear Handle, but more studies are necessary so that it can be said that these points have sedating and calming effects for anxiety.

Eligibility criteria: Inclusion Criteria:

* Voluntary participation in the study with available time for submission to the sessions, which occur over two months.
* Have a score of stress medium, high or very high in the LSS questionnaire, completion of the STAI and general form.

Exclusion Criteria:

* Pregnant students. The only contraindication to this treatment is for pregnant women until the 3rd month of pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04126889: Awareness and Knowledge of the Surgical Safety Checklist Among Operational Staff in University Teaching Hospital, Kathmandu, Nepal: A Cross-sectional Questionnaire
Official title: Awareness and Knowledge of the Surgical Safety Checklist Among Operational Staff in University Teaching Hospital, Kathmandu, Nepal: A Cross-sectional Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Checklist
Lead sponsor: Fukushima Medical University
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 150
Sex: ALL
Minimum age (years): 24
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: health professionals in operation room

Brief summary: The introduction of the World Health Organization Surgical Safety Checklist (WHO SSC) is a priority to promote surgical safety. However, little is known regarding awareness and knowledge of the WHO SSC in developing countries. This study aimed to obtain region-specific information for the introduction of the checklist in a core medical institution in Nepal.

The present research was a cross-sectional study using data from a survey conducted at the Tribhuvan University Teaching Hospital (TUTH) in Kathmandu, Nepal. A questionnaire was distributed to 150 healthcare professionals working in the operating theatre. Responses to the questionnaire were analysed descriptively and regression analyses identified factors associated with awareness of the checklist.


Eligibility criteria: Inclusion Criteria:

* have optimal experience

Exclusion Criteria:

* less experience

Primary outcomes:
measure: Awareness of Surgical Safety Checklist
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Tribhuvan University Teaching Hospital
Study officials:
References:
Clinical trial NCT01386229: A Comparison of Etomidate and Ketamine for Anesthesia Induction in Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Bypass Surgery
Keywords: hemodynamic stability
etomidate
ketamine
coronary artery bypass surgery after induction of anesthesia, hemodynamic stability
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2011-07-01
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
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 whether ketamine is an acceptable alternative to etomidate for anesthesia induction in coronary artery bypass graft surgery in terms of hemodynamic stability and also to compare these agents regarding their effect on adrenal gland steroid synthesis in these patients.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective coronary artery bypass graft surgery with cardiopulmonary bypass
* Patient's written informed consent for study participation
* Ejection fraction ≥ 35%

Exclusion Criteria:

* Allergy to study drugs
* Redo surgery

Primary outcomes:
measure: A more than 15% change in mean arterial pressure and heart rate after anesthesia induction
timeFrame: For 60 minutes after anesthesia induction
Secondary outcomes:
measure: Adrenal gland steroid synthesis suppression
timeFrame: 24 hours and 5 days after study drug administration
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University, Faculty of Medicine
state: Çankaya
Study officials:
affiliation: Baskent University, Faculty of Medicine
name: Özgür Kömürcü
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02981329: Fetal Hemoglobin Induction Treatment Metformin
Official title: Use of Metformin as a Fetal Hemoglobin Inducer in Patients With Hemoglobinopathies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Sickle Cell Anemia
Sickle Cell Disease
Hemoglobin Disorder
Keywords: Metformin
Sickle Cell Anemia
Sickle Cell Disease
Hemoglobinopathies
Hemoglobin Disorder
Blood Disease
Hemoglobin Disease
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2016-12-05
Enrollment: 37
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether metformin is effective in the treatment for sickle cell anemia (SCA).

Detailed description: This is a dose escalation, pilot study for subjects with sickle cell anemia (SCA) disease to determine if metformin has a beneficial effect on the treatment and quality of life of SCA patients.

Eligibility criteria: Inclusion Criteria:

1. Confirmed diagnosis of sickle cell anemia
2. Age greater than or equal to 10 and less than or equal to 60 years of age.
3. If on hydroxyurea, fetal hemoglobin less than 20% at a stable dose (mg/kg) determined by the primary hematology provider over at least four months.
4. Creatinine less than or equal to 1.4 mg/dL and estimated glomerular filtration rate greater than 45 ml/min/1.73 m2
5. Liver function tests (specifically ALT and conjugated bilirubin) less than or equal to 4 times upper limits of normal.

Exclusion Criteria:

1. Failure to meet inclusion criteria
2. Simple or chronic red blood cell transfusion therapy in the last 3 months OR a HbA level greater than 5% in SCA patients
3. Refusal to use medically effective birth control if female and sexually active.
4. If on hydroxyurea, not at stable dose of hydroxyurea for a minimum of 4 months (temporary exclusion).
5. Creatinine greater than 1.4mg/dL
6. Liver function tests (ALT and conjugated bilirubin) greater than 4 times upper limits of normal.

Primary outcomes:
measure: Change in Fetal Hemoglobin (HbF) Percentage (SCA) or Change in Total Hemoglobin (Hb)
timeFrame: 1 Year
Secondary outcomes:
measure: Change in Laboratory Values
timeFrame: 1 Year
measure: Impact on Quality of Life
timeFrame: 1 Year
measure: Variability of Hemoglobin Response
timeFrame: 1 Year
measure: Evaluation of RNA Sequencing
timeFrame: 1 Year
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Titilope Fasipe, MD
role: PRINCIPAL_INVESTIGATOR
References: