louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04701450: Evaluation of Digital, Telephonic and Conventional Consent for Anaesthesia
Official title: Questionnaire Study to Evaluate Patient Satisfaction Between Digital, Telephonic and Conventional Obtaining of Consent for Anaesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Satisfaction
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 750
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: All patients for whom consent for anaesthesia is obtained for an elective procedure

Brief summary: In this study, the investigators aim to evaluate patient satisfaction between three methods of obtaining informed consent for anaesthesia. Patients are asked to partake in a short survey after being informed about the anaesthetic procedure either conventionally in the anesthesia department, telephonically or digitally.

Detailed description: Patient satisfaction plays an important role to improve the process of medical procedures as well as patient outcome. Evaluating the subjectively experienced satisfaction is challenging. The investigators will use a questionnaire and assess waiting times in the process to determine patient satisfaction between digital, telephonic and conventional obtaining of informed consent for anaesthesia.

In this questionnaire study, patients are asked to partake in a survey after the process of obtaining consent for anaesthesia is completed. The questionnaire covers aspects of patient satisfaction with the process, such as subjective assessment of comprehensibility, waiting time and privacy.

Patients are divided into three groups. In one group, consent is obtained conventionally, in form of a visit to our anaesthesia department. In the other two groups, consent is obtained telephonically and digitally, respectively. Patients are not randomised into these groups, but included into the study after the process of obtaining consent by one of the three methods mentioned above is completed.

Eligibility criteria: Inclusion Criteria:

* Patients for whom consent for anaesthesia is obtained

Exclusion Criteria:

* Age \< 18 years
* Language barrier
* Patients with appointed legal guardians
* Patients unable to provide informed consent

Primary outcomes:
measure: Patient satisfaction after informed consent
timeFrame: Immediately after obtaining informed consent
Secondary outcomes:
measure: Overall waiting time of patients
timeFrame: Up to three hours; from administration for informed consent until completion of informed consent
measure: Time expense of informed consent
timeFrame: Up to 60 minutes; from start until end of informed consent
measure: Intraoperative complications
timeFrame: Up to 12 hours; From start until end of the planned surgical procedure
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna General Hospital
Study officials:
affiliation: Medical University of Vienna
name: David M. Baron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00347750: Pharmacokinetics and Pharmacodynamics of an Anti-HIV Drug in Israeli Ethiopian and Non-Ethiopian Populations
Official title: Pharmacokinetics and Pharmacodynamics of Lopinavir an Anti-HIV Drug in Israeli Ethiopian and Non-Ethiopian Populations
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: HIV Infection
AIDS
Keywords: Lopinavir
Pharmacokinetic
Pharmacodynamic
Ethiopian population
Caucasian population
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Israel
First posted: 2006-07-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The objective of this proposal is based on the assumption that the HIV infected Ethiopian population responded in a different way in comparison to the Caucasian subjects to Lopinavir therapy. Our preliminary data demonstrated that Ethiopian's have different Lopinavir serum concentration in comparison to non-Ethiopian's. For these reasons the plan of this study is to investigate the pharmacokinetic/pharmacodynamic (PK/PD) profile in both populations. The results will allow to establish a better personalised medicine for HIV infected individuals.

Detailed description: The objective of this proposal is based on the assumption that the HIV infected Ethiopian population responded in a different way in comparison to the Caucasian subjects to Lopinavir therapy. Our preliminary data demonstrated that Ethiopian's have different Lopinavir serum concentration in comparison to non-Ethiopian's. For these reasons the plan of this study is to investigate the pharmacokinetic/pharmacodynamic (PK/PD) profile in both populations. The results will allow to establish a better personalised medicine for HIV infected individuals.

Eligibility criteria: Inclusion Criteria:

* All HIV infected Ethiopian and Non-Ethiopian subjects
* AIDS diseased Ethiopian and Non-Ethiopian individuals

Exclusion Criteria:

* Individuals who are unable to sign the informed concent
* Individuals unable to take oral medications
* Individuals who described Lopinavir allergy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Norberto Krivoy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05330650: Evaluation of Triclosan Coated Suture in Obstetrical Surgery
Official title: Evaluation of Triclosan Coated Suture in Obstetrical Surgery: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Section; Infection
Keywords: Surgical Site Infections
caesarean section
healthcare costs
Lead sponsor: Tunis University
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 318
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A prospective comparative randomized blinded study conducted in the obstetrics gynecology department of Ben Arous hospital over an eight-month period between November 2020 and June 2021.

The aim of this study is to evaluate effectiveness of Triclosan coated suture use in obstetrical surgery.


Eligibility criteria: Inclusion Criteria:

* Pregnant women with indicated cesarean delivery and who have signed a written consent.

Exclusion Criteria:

* Cases with incomplete follow up
* Breach of operative protocol

Primary outcomes:
measure: Incidence of surgical site infection
timeFrame: 30 days
Secondary outcomes:
measure: Health care costs attributable to surgical site infection
timeFrame: 30 days
measure: Wound healing time
timeFrame: 30 days
Other outcomes:
Locations:
city: Ben Arous
country: Tunisia
facility: Obstetrics and Gynecology Departement
Study officials:
affiliation: Ben Arous Hospital, Tunis, Tunisia
name: Chaouki Mbarki
role: STUDY_DIRECTOR
References:
Clinical trial NCT06365450: Breast and Cervical Cancer Education Program
Official title: OWEL Cancer Education and Awareness Program (OCEAP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Breast Cancer
Health Behavior
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Older Women Embracing Life
name: The John G. Bartlett Specialty Practice
First posted: 2024-04-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each participant is required to attend (in person or virtually via Zoom) two educational sessions one on breast cancer and the other on cervical cancer.
Primary purpose: OTHER

Brief summary: The primary goal of this study is to improve cancer literacy in Black women living with HIV and ultimately improve breast and cervical cancer screening uptake. This study involves an educational intervention delivered virtually and in person, depending on the participants' preference.

Detailed description: The aims of this study are to:

1. develop educational materials on breast and cervical cancer screening;
2. administer the intervention using a PowerPoint presentation;
3. evaluate changes in breast and cervical cancer literacy levels after the intervention; and
4. assess participants'; satisfaction with the program

Eligibility criteria: Inclusion Criteria:

* able to read and write in English
* self-identify as HIV positive -
* Black/African American.

Exclusion Criteria:

* Acutely ill

Primary outcomes:
measure: Health Literacy in Cancer Screening as assessed by the Assessment of Health Literacy in Cancer Screening (AHL-C) tool.
timeFrame: Immediately Post intervention
Secondary outcomes:
measure: Number of participants recruited from each community partner
timeFrame: Immediately Post intervention
measure: Number of participants who preferred virtual or in person sessions
timeFrame: Immediately Post intervention
measure: Number of participants who were lost of follow up
timeFrame: Immediately post intervention
measure: Number of participants who needed help redeeming their gift codes
timeFrame: Immediately post intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Nursing
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Hae-Ra Han, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04549350: Sleep Quality Among HCWs
Official title: Sleep Quality Among Health Care Workers During COVID-19 Pandemic: Kuwait Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Quality
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, Kuwait
First posted: 2020-09-16
Enrollment: 217
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health care workers (HCWs) at Kuwaiti Ministry of Health hospitals ,Kuwait during the period from May 2020 to July 2020

Brief summary: The novel coronavirus has brought the world into uncharted waters. Whole countries are on lockdown, the economy has ground to a halt, and many people are afraid for themselves and their loved ones. With such unprecedented changes coming on so quickly, it's understandable that the importance of sleep is flying under the radar. But as we adjust to stay-at-home orders and try to remain healthy in a time of COVID-19, focusing on sleeping well offers tremendous benefits.

Millions of people suffered from insomnia before the coronavirus, and unfortunately, the pandemic creates a host of new challenges even for people who previously had no sleeping problems. The coronavirus pandemic doesn't affect everyone in the same way. Of course, patients with the virus and front-line medical workers face the brunt of the direct impacts of the disease. Social distancing, school closures, quarantines, working-from-home: all bring profound changes to normal routines for people of all ages and walks of life.

The aim of the current work is to assess the sleep quality among health care workers in the front-line management of COVID-19 in Kuwaiti Ministry of Health hospitals and its relation on medical errors.


Eligibility criteria: Inclusion Criteria:

-Health care workers at Kuwait Ministry of Health hospitals during the period from May 2020 to July 2020

Exclusion Criteria:

* Care givers above 60 years
* those who refuse to participate or requested to withdraw from the study at any time
* HCWs who were not on duty at the time of survey due to any leave or absence
* replies with incomplete answers or duplicate answers

Primary outcomes:
measure: Presence of poor sleep quality or not
timeFrame: one month period
Secondary outcomes:
measure: reported medical errors
timeFrame: one month
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
Study officials:
References:
Clinical trial NCT04840550: Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs
Official title: A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tegoprazan 25 mg for the Prevention of Peptic Ulcer Disease in Patients on Continuous Long-term Treatment With NSAIDs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Preventive Peptic Ulcer
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2021-04-12
Enrollment: 390
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to confirm the non-inferiority of Tegoprazan 25 mg, compared to Lansoprazole 15 mg, to prevent gastroduodenal ulcers and verify the safety of tegoprazan following oral administration of tegoprazan 25 mg QD or lansoprazole 15 mg QD in patients on long-term treatment with NSAIDs.

Detailed description: This is a double-blind, randomized, active-controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 25 mg, lansoprazole 15 mg).

Eligibility criteria: Inclusion Criteria:

* ≥60 years of age, or ≥20 years of age with a history of gastroduodenal ulcers (gastric and/or duodenal ulcers) at screening
* Requires continued treatment with NSAIDs for ≥24 weeks

Exclusion Criteria:

* Has an active stage (A1, A2) or healing stage (H1, H2) of gastroduodenal ulcers per the Sakita-Miwa classification identified by upper GI endoscopy at screening
* Has uncontrolled severe hypertension
* Has severe heart failure, congestive heart failure (NYHA Ⅱ to Ⅳ), ischemic heart disease (unstable angina, myocardial infarction), or peripheral artery disease, or has undergone coronary artery bypass graft (CABG) who is considered ineligible for treatment with NSAIDs
* Has a positive H. pylori test at screening

Primary outcomes:
measure: Proportion of subjects with gastric and/or duodenal ulcers at Week 24
timeFrame: week 24
Secondary outcomes:
measure: Proportion of subjects without NSAID-related GI symptoms at Weeks 4, 12, and 24
timeFrame: week 4, 12, 24
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The catholic univ. of Korea Eunpyeong ST. Mari's hospital
Study officials:
affiliation: Samsung Medical Center
name: Jea Jun Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00232050: Study of Omalizumab in Moderate to Severe Bronchial Asthma
Official title: Study of Omalizumab in Moderate to Severe Bronchial Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma, IgE, Omalizumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo Co., Ltd.
First posted: 2005-10-04
Enrollment: 327
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of omalizumab up to 16 weeks in adult patients with moderate to severe bronchial asthma.


Eligibility criteria: Inclusion Criteria:

* Allergic asthma patients
* Inadequately controlled patients

Exclusion Criteria:

* - History of severe anaphylactoid or anaphylactic reactions
* Previous treatment with omalizumab
* History of cancer or cancer

Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Morning peak expiratory flow (PEF) at baseline and end of treatment.
Secondary outcomes:
measure: Pulmonary function parameters measured by spirometer
measure: Frequency of rescue medication use
measure: Symptom score
measure: Activities of daily living score
measure: Nighttime sleep score
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals Japan
name: Novartis Pharmaceuticals Japan
role: STUDY_CHAIR
References:
Clinical trial NCT04540055: General Anesthesia and Paravertebral Blocks vs. General Anesthesia Only: Influence Inflammation Factors and Clinical Outcomes in Modified Radical Mastectomy
Official title: Effects of General Anesthesia vs. General Anesthesia and Paravertebral Block to IL-2, IL-6, PGE2, MMP-9, and Clinical Outcome in Modified Radical Mastectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Local
Anesthesia
Inflammatory Response
Pain, Postoperative
Lead sponsor: Udayana University
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with breast cancer (stadium Ia-IIIb) who underwent MRM surgery under general anesthesia in Sanglah General Hospital

Brief summary: Regional anesthesia and analgesia may maintain immune function, reduce surgical stress, and also reduce volatile anesthetics and opioids requirements. Local anesthetic drugs used in regional anesthesia and analgesia work to have anti-proliferative and cytotoxic effects on cancer cells. Pro-inflammatory cytokines such as IL-1, IL-6, and TNF-alpha increase in levels in peripheral nerves, spinal cord, brain (brain stem, locus sereleus, thalamus, hippocampus, and prefrontal cortex) after peripheral nerves are injured. The anti-inflammatory cytokine IL-10 is decreased in levels after peripheral nerve injury. The balance between pro-inflammatory and anti-inflammatory cytokines affects the severity of pain.


Eligibility criteria: Inclusion Criteria:

* Patient with breast cancer (stadium Ia, Ib, IIa, IIb, IIIa, IIIb) undergoing MRM surgery
* Balinese race
* ASA physical status I, II, III

Exclusion Criteria:

* History of allergy to drugs used in anesthesia
* History psychiatric disorder
* History of perioperative transfusion
* History of autoimmune disease
* History of taking beta blockers or anti-platelet aggregation medications
* Previous breast surgery
* Spine deformity
* Coagulopathy
* Local infections in paravertebral block site
* Decreased renal function
* Neurological deficits
* Peptic ulcer

Primary outcomes:
measure: Concentration of IL-2 in blood serum
timeFrame: 1-hour after surgery
measure: Concentration of IL-2 in blood serum
timeFrame: 24-hours after surgery
measure: Concentration of IL-6 in blood serum
timeFrame: 1-hour after surgery
measure: Concentration of IL-6 in blood serum
timeFrame: 24-hours after surgery
measure: Visual Analog Scale (VAS)
timeFrame: 24-hours after surgery
Secondary outcomes:
measure: Concentration of PGE2 level in blood serum
timeFrame: 1-hour after surgery
measure: Concentration of PGE2 level in blood serum
timeFrame: 24-hours after surgery
measure: Concentration of MMP-9 level in blood serum
timeFrame: 1-hour after surgery
measure: Concentration of MMP-9 level in blood serum
timeFrame: 24-hours after surgery
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: Sanglah General Hospital
state: Bali
Study officials:
References:
Clinical trial NCT00917150: To Investigate the Efficacy and Safety of OPC-6535 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: A Phase 2, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm, Dose-comparison Trial of OPC-6535 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease
COPD
emphysema
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-06-10
Enrollment: 771
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and safety of OPC-6535 in COPD patients, using the measurement of trough FEV1 over time as the primary endpoint.


Eligibility criteria: Inclusion Criteria:

* Age 40 to 75 years, inclusive, at the time informed consent is obtained
* Ability to provide own written informed consent
* Agree to use an appropriate method of contraception until 3 months after the last dose of the investigational medicinal product (IMP)
* A rating of 1 or higher on the Goddard scale in assessment of emphysema severity by chest CT scan at screening
* Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) of less than 70% at screening
* Cigarette smoking history of at least 20 pack years at screening

Exclusion Criteria:

* Subjects with obstructive disorders due to bronchial asthma
* Subjects receiving long-term oxygen therapy
* Subjects with active tuberculosis or obvious bronchiectasis
* Complication of malignant tumor
* Uncontrolled cardiovascular, endocrine, blood, or nervous system disorders
* Uncontrolled condition with COPD exacerbation of level 2 or 3 within 8 weeks prior to the start of washout period (within 12 weeks prior to start of treatment period)

Primary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) Change From Baseline to 24 Months
timeFrame: Baseline, 24 months
Secondary outcomes:
measure: Change From Baseline at 24 Months in Total Symptom Diary Score
timeFrame: Baseline, 24 months
measure: Change From Baseline at 24 Months in St. George's Respiratory Questionnaire (SGRQ) Total Score
timeFrame: Baseline, 24 months
Other outcomes:
Locations:
city: Central China Area
country: China
city: East China Area
country: China
city: North China Area
country: China
city: Northeast China Area
country: China
city: Northwest China Area
country: China
city: South China Area
country: China
city: Southwest China Area
country: China
city: Kansai Region, Et Al.
country: Japan
city: Seoul, Et Al.
country: Korea, Republic of
Study officials:
References:
Clinical trial NCT02010450: Re-enforcing Safe Sleep Practices for Caregivers With Tangible Incentives
Official title: Re-enforcing Safe Sleep Practices for Caregivers With Tangible Incentives: Pilot Testing of the MSSC Physician Safe Sleep Taskforce Caregiver Incentive Toolkit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safe Sleep Education
Keywords: Sudden Infant Death Syndrome
SIDS
safe sleep
safe sleep message
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2013-12-12
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a pilot study to test the effectiveness of incentive items to increase compliance of infant safe sleep practices among caregivers.


Eligibility criteria: Inclusion Criteria:

* Parent of 1-month old baby
* Over the age of 18
* Be able to speak and read English

Exclusion Criteria:

-

Primary outcomes:
measure: dichotomous sleep variable (safe vs unsafe)
timeFrame: Change from Baseline to 2 Months
Secondary outcomes:
measure: determine which incentive item provided is most effective in reinforcing the safe sleep message
timeFrame: Change from Baseline to 2 Months
Other outcomes:
Locations:
city: Wichita
country: United States
facility: KU Wichita Pediatrics
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Carolyn R Ahlers-Schmidt, PhD
role: PRINCIPAL_INVESTIGATOR
References: