louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05413577: Reducing Parental Stress Via Instant Messaging During COVID-19 Pandemic: A Randomized Controlled Trial
Official title: Reducing Parental Stress Via Instant Messaging During COVID-19 Pandemic: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parents
Parenting
Stress
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 491
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: This research investigated the effects of mindfulness practice on mental wellbeing and parenting behaviour, with the instruction recordings delivered via existing instant messaging applications, including Whatsapp and Signal. The two-week mindfulness program targeted parents with children in Nursery, Kindergarten to Primary School. Due to the suspension of schools, work from home policies, parents spend increased amount of time with their children. News reports have indicated that with the mounting care taking responsibilities and downturn of economy amidst the epidemic, parents have been experiencing higher stress that may negatively impact their wellbeing and parent-child relationship. This study delivered an app-based intervention that aims at enhancing mindful parenting at the time of corona, where social distancing is emphasized.


Eligibility criteria: Inclusion Criteria:

Parents with at least one child who is in Primary School or below.

Primary outcomes:
measure: Parental Stress Scale
timeFrame: Change from Baseline Parental Stress Scale at immediately after the intervention and two weeks after intervention
Secondary outcomes:
measure: Well-being WHO 5-item index
timeFrame: Change from Baseline Well-being WHO 5-item index at immediately after the intervention and two weeks after intervention
measure: Mindfulness in Parenting Scale
timeFrame: Change from Baseline Interpersonal Mindfulness in Parenting scale at immediately after the intervention and two weeks after intervention
measure: Parent Behavior Inventory
timeFrame: Change from Baseline Parent Behavior Inventory at immediately after the intervention and two weeks after intervention
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Lun Wai Doris Lam, M.S.Sc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01681277: Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 in Healthy Male Volunteers
Official title: Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 Powder for Oral Solution in Healthy Male Volunteers q.d. or b.i.d. for 14 Days (a Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-09-07
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of multiple rising doses of BI 113608 in healthy male volunteers


Eligibility criteria: Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Primary outcomes:
measure: Percentage of Participants With Drug-related Adverse Events
timeFrame: From administration of study drug until end-of-study, up to 17 days
measure: Number of Participants With Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, and ECG Recordings
timeFrame: From administration of study drug until end-of-study, up to 17 days
Secondary outcomes:
measure: Cmax,ss
timeFrame: 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.
measure: Tmax,ss
timeFrame: 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.
measure: AUCtau,ss
timeFrame: 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.
measure: t1/2,ss
timeFrame: 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 360h, 384h after last dose.
measure: RA,Cmax
timeFrame: -2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.
measure: RA,AUC
timeFrame: -2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT00729677: Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Oxaliplatin
Official title: Prevalence of Delayed Nausea and Vomiting in Patients Being Treated With Oxaliplatin-based Regimens (mFOLFOX6 or FOLFOX7) for Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Nausea
Vomiting
Keywords: nausea and vomiting
colon cancer
rectal cancer
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2008-08-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiveing chemotherapy including oxaliplatin at the ambulatory care center

Brief summary: RATIONALE: Learning how often patients experience nausea and vomiting after receiving anti-vomiting medicine and chemotherapy for colorectal cancer may help doctors plan better treatment and improve patients' quality of life.

PURPOSE: This clinical trial is studying delayed nausea and vomiting in patients with colorectal cancer receiving standard anti-vomiting medicine during the first course of chemotherapy.

Detailed description: OBJECTIVES:

* To assess the prevalence of delayed nausea and vomiting in patients with colorectal cancer receiving standard anti-emetic medications during the first course of an oxaliplatin-based chemotherapy regimen (mFOLFOX6 or FOLFOX7).

OUTLINE: This is a multicenter study.

Patients undergo collection of demographic, diagnostic, and treatment data at baseline. Patients complete the Functional Living Index-Emesis (FLIE) questionnaire at baseline prior to first chemotherapy infusion and at 5-7 days. Patients also fill out daily patient diaries about symptoms of nausea and vomiting, and use of medications to prevent these symptoms over days 1-5.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of colorectal cancer
* Currently receiving OR scheduled to receive the first course of either of the following chemotherapy regimens:

  * mFOLFOX6
  * FOLFOX7
* No clinical or imaging evidence of brain metastasis

PATIENT CHARACTERISTICS:

* Able to maintain a diary and complete a standardized quality of life questionnaire in English

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* More than 90 days since prior aprepitant

Primary outcomes:
measure: Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy
timeFrame: Week 1 of FOLFOX chemotherapy
measure: Impact of Nausea and Vomiting on the Patient's Quality of Life as Measured by the Functional Living Index - Emesis Scale at 5-7 Days
timeFrame: Week 1
measure: Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy
timeFrame: week 1
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Beth Israel Medical Center - Philipps Ambulatory Care Center
state: New York
Study officials:
affiliation: Beth Israel Medical Center
name: Stewart Barry Fleishman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05730777: Correlation Between Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy and the Preventive of Probiotics
Official title: Correlation Between Early Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy and the Preventive and Curative Effects of Probiotics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cancer Therapy-related Cardiovascular Toxicity
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 explore the relationship between early myocardial injury caused by tumor drug therapy and intestinal microbial structure changes by echocardiographic two-dimensional speckle tracking technique and intestinal microflora structure detection. The investigators will also explore prevention and treatment through randomized controlled trials to initiate early intervention before clinical symptoms appear.

Detailed description: This is a single-center randomized controlled trial in which 100 patients treated with antineoplastic agents will be enrolled. All participants will be followed for 6 months after the initiation of oncology drug therapy. Echocardiography and 2D speckle tracking will be performed and stool and blood samples will be tested before treatment initiation and at 3 and 6 months after initiation. All patients will be randomly divided into test and control groups. Patients in the test group will receive oral Bifidobacterium trivium capsules for 6 months in addition to conventional treatment, whereas patients in the control group will receive conventional antitumor treatment only.

Eligibility criteria: Inclusion Criteria:

* With malignant tumors
* Will receive antitumor drugs
* Could receive regular follow-up for 6 months
* Written informed consent

Exclusion Criteria:

* Satisfactory echocardiographic images could not be obtained
* Cardiomyopathy
* Coronary artery disease
* Heart failure
* Arrhythmia requiring intervention
* Moderate or severe valvular disease
* Acute myocarditis
* Refractory hypertension
* Participating in other studies of drug intervention

Primary outcomes:
measure: The decline rate of global longitudinal strain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Ming Cui, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06210477: Association With Low Compliance Bladder in Women With LUTS
Official title: Comparisons of Clinical and Urodynamic Parameters and Persistence in the Treatment for Women With Different Types of Low Bladder Compliance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Bladder, Overactive
Urinary Bladder Neck Obstruction
Pelvic Organ Prolapse
Urinary Incontinence
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 200
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: Women with lower urinary tract symptoms

Brief summary: Hypothesis / aims of study The clinical and urodynamic features on the severity of low compliance bladder in neurologically intact women with lower urinary tract symptoms are indeterminate. Thus, this study aimed to elucidate the above association.

Study design, materials and methods Between January 1996 and December 2021, the medical records of all consecutive women who underwent urodynamic studies for their lower urinary tract symptoms were reviewed to elucidate the clinical significance of low bladder compliance.


Eligibility criteria: Inclusion Criteria:

* Urodynamic finding with low bladder compliance

Exclusion Criteria:

* Nil.

Primary outcomes:
measure: Bladder capacity (mL)
timeFrame: 1996/1/1~2021/12/31
Secondary outcomes:
measure: Persistence rates of treatment (%)
timeFrame: 1996/1/1~2021/12/31
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Obstetrics and Gynecology, National Taiwan University Hospital
Study officials:
affiliation: Department of Obstetrics and Gynecology, National Taiwan University Hospital
name: Ho-Hsiung Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06331377: Clinical and Molecular Characteristics of Histiocytic Disorders
Official title: Clinical and Molecular Characteristics of Histiocytic Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Histiocytic Disorder
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed with histiocytic disorders

Brief summary: This study is being done to collect medical and personal histories as well as a samples of blood, other body fluid and/or tumor/disease tissue for current and future research studies on histiocytic disorders.

Detailed description: PRIMARY OBJECTIVES:

I. Define molecular signature and genomic landscape of histiocytic disorders. II. Correlate genomic findings with transcriptional abnormalities. III. Identify promising prognostic alterations and potential therapeutic targets.

OUTLINE: This is an observational study.

Patients complete questionnaires and undergo blood and tissue sample collection. Patients' medical records are also reviewed.

Eligibility criteria: Inclusion Criteria:

* \* All patients diagnosed with histiocytic disorders and age ≥1 year

Exclusion Criteria:

* \* \< 1 years age

Primary outcomes:
measure: Identify molecular markers
timeFrame: Baseline
measure: Change in PD-L1 and T-cell Bim expression
timeFrame: Baseline; post-treatment (estimated up to 2 years, potentially 4 times per year)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Ronald S. Go, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06171477: Regional Distribution of Ventilation at Different Respiratory Rates
Official title: Regional Distribution of Ventilation in Different Respiratory Rates: A Study of Mechanically Ventilated Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mechanical Ventilation
Atelectasis
Distribution of Ventilation
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will investigate the distribution of gas during mechanical ventilation in patients undergoing robot assisted laparoscopic prostatectomy. The gas distribution of ventilation are monitored and data extracted using electric impedance tomography in different respiratory rates.

Detailed description: Mechanical ventilation during anaesthesia and intensive care often results in an uneven gas distribution of ventilation. Patients anaesthetized for laparoscopic surgery and patients positioned i a Trendelenburg position is particularly at risk.

A less harmful mode of ventilation could possible lead to a more optimal ventilation with avoidance of ventilator induced lung injuries. The project will investigate if volume controlled ventilation with a higher respiratory frequency can be used in this purpose.

The researchers intend to investigate patients, without previously known lung disease, undergoing robot-assisted laparoscopic prostatectomy. After the patients have given informed consent, they will be included in the project. The distribution of ventilation will be monitored with electric impedance tomography (EIT). Once the patients have been anaesthetized, positioned with the head down and the surgical procedure have been started with insufflation of carbon dioxide we will start our test.

The investigators will perform three episodes of standardized ventilation with the respiratory rate (RR) of 20, 40 and 60. With a higher RR the tidal volume will be reduced tom maintain a constant inhaled minute volume. Data will be collected from the EIT-equipment, the anaesthesia machine and the monitoring system.

Eligibility criteria: Inclusion Criteria:

* Patients planned for robot-assisted laparoscopic prostatectomy
* \> 18 years
* Consent to take part in the study

Exclusion Criteria:

* Impaired cognitive function
* Previously known lung disease
* Insufficient skills in Swedish language to understand information about the study

Primary outcomes:
measure: Distribution of ventilation
timeFrame: During the prostatectomy procedure
Secondary outcomes:
measure: Distribution of ventilation
timeFrame: During the prostatectomy procedure
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Region Örebro län
Study officials:
affiliation: Örebro University, Sweden
name: Pether Jildenstål, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05628077: Prevalence and Risk Factors for Pain and Related Adverse Reactions Among Breast Cancer Survivors on Aromatase Inhibitors
Official title: Doctor of Medical Sciences
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Aromatase Inhibitors
Endocrine Therapy
Pain
Anxiety
Depression
Sleep
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2022-11-28
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: I-III Breast cancer survivors on aromatase inhibitors

Brief summary: We obtained the occurrence of pain sensation, pain mood, sleep, etc. during endocrine therapy in breast cancer patients through telephone follow-up, and analyzed risk factors through artificial intelligence


Eligibility criteria: Inclusion Criteria:

- Breast cancer survivors on aromatase inhibitors

Exclusion Criteria:

* Advanced breast cancer

Primary outcomes:
measure: Prevalence and risk factors for pain and related adverse reactions among breast cancer survivors on aromatase inhibitors
timeFrame: 2022-10 ---2023-03
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People'S Hospital
Study officials:
References:
Clinical trial NCT03592277: Vitamin C & Thiamine to Treat Sepsis and Septic Shock
Official title: Vitamins B1 and C to Improve Outcomes in Patients With Severe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sepsis
Septic Shock
Keywords: Sepsis
Septic Shock
Vitamin C
Thiamine
Lead sponsor: Trinity Health Of New England
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators propose to investigate the use of IV vitamins B1 and C in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock.

Detailed description: Investigators propose to investigate the use of IV vitamins B1 and C in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock. Patients experiencing evidence-based diagnoses of sepsis and severe sepsis and septic shock will be randomized to the two study arms for care, and all other care left to decisions of intensive care teams.

Eligibility criteria: Patients must meet all inclusion criteria:

1. Between the ages of 18 and 90 years old
2. Have severe sepsis or septic shock. Severe sepsis and septic shock will be defined by the Surviving Sepsis 2012 guidelines.
3. Weight more than 30 kg
4. Full code

Exclusion Criteria:

1. Not diagnosed with severe sepsis or septic shock
2. Younger than 18 or older than 90 years old
3. With a history of nephrolithiasis
4. Who are pregnant
5. Weigh less than 30 kg
6. Not located in the ICU
7. Do not resuscitate (DNR) or do not intubate (DNI), no escalation of care, or comfort measures only (CMO)
8. Currently on dialysis

Primary outcomes:
measure: Mortality Rates
timeFrame: From time of treatment to 30 days post hospital discharge, up to 87 days.
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: From admission to the hospital through hospital discharge, up to 57 days.
measure: Intensive Care Unit Length of Stay
timeFrame: From time of admission to the ICU through discharge from the ICU, up to 25 days
measure: Readmission Rate
timeFrame: 30 days after hospital discharge
measure: Ventilator Days
timeFrame: From admission to the ICU through discharge from the ICU, up to 25 days.
measure: Hours on Vasopressors
timeFrame: From admission to the ICU through discharge from the ICU, up to 25 days.
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Saint Francis Hospital and Medical Center
state: Connecticut
Study officials:
affiliation: Saint Francis Hospital and Medical Center
name: David Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
References: