louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01386060: Mindfulness Meditation in Chronic Stress
Official title: Mindfulness Meditation in Chronic Stress: Measures of Adherence, Ability & Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Stress
Mindfulness
Meditation
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2011-06-30
Enrollment: 134
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study purpose is to evaluate efficacy of a mindfulness training intervention and learn about cognitive and physiological markers of stress.

Detailed description: Subjects will first undergo a phone screening, and if eligible, they will complete three study visits at Week 1, Week 8, and Week 15. The study visits involve at-home surveys, voice recordings, physical measures (height, weight, waist-to-hip ratio, and blood pressure), EEG recordings (including recordings of electrodermal activity and heart rate variability), computer tasks, in-lab saliva collection, overnight urine collection, 2-day saliva collection at bed waking, 30 minutes post-waking, afternoon, and bedtime, and a small handheld device that randomly administers eight short assessments in the subjects' natural environment. Subjects will be randomized to receive a 6-week mindfulness meditation course either between the first and second study visits or between the second and third study visits. Participants who receive training during the first and second visits will continue meditating until the third visit. The one-on-one instruction occurs once a week for 1 ½ hours, and participants are asked to listen to guided meditations and do other mindfulness-based tasks on a daily basis between sessions.

Eligibility criteria: Inclusion Criteria:

* Ages 50-85
* Good General Health
* Experiencing Stress
* No current meditation practice
* English speaking

Exclusion Criteria:

* Cognitive Impairment
* Neurological Disease
* Major Untreated Depression

Primary outcomes:
measure: Changes in Physiological Markers of Stress
timeFrame: Baseline (Week 1) and Visit 2 (Week 8)
Secondary outcomes:
measure: Cognitive Changes
timeFrame: Baseline (Week 1) and Visit 2 (Week 8)
measure: Changes in self-reported measures of stress
timeFrame: Baseline (Week 1) and Visit 2 (Week 8)
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Barry Oken, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03281460: Efficacy of In-bag Morcellation
Official title: Efficacy of In-bag Morcellation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Myomatosis
Laparoscopy
Hysterectomy, Vaginal
Keywords: Hysterectomy, Vaginal
Uterine Myomatosis
Morcellation
Laparoscopy
in-bag morcellation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Laparoscopic mini-invasive surgery supplanted laparotomy for many years, including hysterectomy or myomectomy (less postoperative complications compared to laparotomy) However the US Federal Drug Administration (FDA) strongly warned against the use of power morcellation in 2014 because of the risk of iatrogenic spread of malignant cells.

The hypothesis is that in-bag morcellation may prevent cells dissemination. The investigator compare in this prospective randomized study two groups of patients: group A (in bag-morcellation during laparoscopic myomectomy or hysterectomy) versus group B (morcellation without any bag during laparoscopic myomectomy or hysterectomy)


Eligibility criteria: Inclusion Criteria:

* Women aged 18 years or more
* Laparoscopic myomectomy or laparoscopic subtotal hysterectomy
* Informed and signed consent

Exclusion Criteria:

* Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
* Preoperative risk of leiomyosarcoma or pelvic carcinoma
* Pregnancy or desire of pregnancy during the study period
* Uterus or myomas weight above 1.000 g
* Inability to understand information provided
* Not covered by a national health insurance scheme, prisoner or under administrative supervision

Primary outcomes:
measure: Smooth muscular cells in the peritoneal fluid after morcellation
timeFrame: Day 0 - just after surgery
Secondary outcomes:
measure: duration of surgery
timeFrame: Day 0
measure: morcellation time
timeFrame: Day 0 - during surgery
measure: peritoneal washing time
timeFrame: Day 0 - during surgery
measure: residual morcellated tissues weight
timeFrame: Day 0 - during surgery
measure: bag associated time
timeFrame: Day 0 - during surgery
measure: ease of use
timeFrame: Day 0 - during surgery
Other outcomes:
Locations:
city: Bron
country: France
facility: Gynaecology Department, Hôpital Femme Mère Enfant
Study officials:
affiliation: Gynaecology Department, Hôpital Femme Mère Enfant, HCL
name: Gautier CHENE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01707160: Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy Volunteers
Official title: A Randomised, Double-blind 2 Way Crossover Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Insulin X14 30/70 PreMix Compared to Human Insulin 30/70 PreMix in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-10-16
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics and pharmacodynamics of insulin X14 30/70 PreMix compared to human insulin 30/70 PreMix in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Non-smokers
* BMI (body mass index) maximum 27 kg/m\^2
* HbA1c (glycosylated haemoglobin A1c): 3.4-6.1%
* FBG (fasting blood glucose) maximum 6.0 mmol/L

Primary outcomes:
measure: Area under the Curve
Secondary outcomes:
measure: Maximum insulin concentration (Cmax)
measure: Time to maximum insulin concentration (tmax)
measure: Minimum glucose concentration (Cmin(glu))
measure: Time to minimum glucose concentration (tmin(glu))
measure: Adverse events
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR,1452)
role: STUDY_DIRECTOR
References:
citation: Jacobsen LV, Sogaard B, Riis A. Pharmacokinetics and pharmacodynamics of a premixed formulation of soluble and protamine-retarded insulin aspart. Eur J Clin Pharmacol. 2000 Aug;56(5):399-403. doi: 10.1007/s002280000159.
Clinical trial NCT05458960: Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rate
Official title: Evaluating the Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rate: The BASICS Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Keywords: Colposcopy
Cervical cancer prevention
Adherence to follow-up
Unmet social needs
Distress
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-07-14
Enrollment: 81
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators will perform a randomized controlled trial in which 72 eligible patients (low-income, uninsured, or on Medicaid) who are referred for colposcopy at Washington University School of Medicine, are enrolled and then screened for unmet social needs and distress. The participants will then be randomized 1:1 into either receive the social needs navigator program (n=36) or enhanced usual care (n=36).


Eligibility criteria: Inclusion Criteria:

* Abnormal cervical cancer screen
* Missed appointment at BJH colposcopy clinic and need to reschedule
* Age 21 years or older
* Able to provide verbal consent
* Diagnosis of an abnormal cervical screen confirmed by cytology or pathology

Exclusion Criteria:

* Individual without a cervix
* Known diagnosis or history of cancer
* Unable to consent

Primary outcomes:
measure: Adherence to colposcopy visit as measured as number of participants who complete colposcopy visit
timeFrame: 6 weeks after enrollment
Secondary outcomes:
measure: Total number of unmet basic needs
timeFrame: 4 months after enrollment
measure: Change in general distress scores as measured by the NCCN Distress Thermometer and Problem List
timeFrame: Enrollment and 4 months after enrollment
measure: Intent to use intervention over time
timeFrame: Completion of study enrollment (estimated to be 18 months)
measure: Patients' satisfaction with intervention
timeFrame: Completion of study enrollment (estimated to be 18 months)
measure: Providers' satisfaction with intervention
timeFrame: Completion of study enrollment (estimated to be 18 months)
measure: Resources needed to sustain intervention
timeFrame: Completion of study enrollment (estimated to be 18 months)
measure: Likelihood that intervention will become built into usual care
timeFrame: Completion of study enrollment (estimated to be 18 months)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Lindsay M Kuroki, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01721460: Effects of Dexmedetomidine on Activity in the Subthalamic Nucleus
Official title: Effects of Dexmedetomidine on Neuronal Activity in the Subthalamic Nucleus During Deep Brain Stimulation (DBS) Electrode Implantation Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Deep Brain Stimulation Surgery
Keywords: SubThalamic Nucleus
Microelectrode recording
Deep Brain Stimulation Electrode implantation
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2012-11-04
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to find out whether dexmedetomidine changes brain cell activity in the subthalamic nucleus (STN).

Detailed description: In order to find whether dexmedetomidine is optimal for sedation during Deep brain stimulation surgery, we will measure the electrical activity in the STN during Deep brain stimulation surgery, and measure how this activity is changed during administration of Dexmedetomidine. We hypothesize that dexmedetomidine does not change the firing rate and pattern in the STN.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo bilateral STN electrode implantation surgery with Micro-electrode recording for the treatment of Parkinson's disease.

Exclusion Criteria:

* Hypersensitivity to dexmedetomidine
* Bradycardia: Sinus rhythm slower than 50 bpm
* Known or suspected obstructive sleep apnea
* Suspected difficult intubation
* Pregnancy
* Under 18 years of age or over 85 years of age
* Cognitive disability impairing understanding the experiment or signing the informed consent form

Primary outcomes:
measure: Change in Average Population Spiking Activity
timeFrame: 20-35 minutes following drug administration
Secondary outcomes:
measure: Change in Average Firing Pattern in the STN
timeFrame: 20-35 minutes following drug administration
measure: Time to Recovery
timeFrame: 20-60 minutes after stopping drug administration
measure: Portion of Participants With Timely Return of the Neuronal Activity to Baseline
timeFrame: 30 minutes after stopping drug administration
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Madison, School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison, Department of anesthesiology
name: Aeyal Raz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02930460: Prospective Cohort Study of Patients Intolerant to High Pressure Under Continuous Positive Airway Pressure Treated With Bilevel Positive Airway Pressure as Second-line Therapy.
Official title: Prospective Cohort Study of Patients Intolerant to High Pressure Under Continuous Positive Airway Pressure, Treated With Bilevel Positive Airway Pressure (AirCurve 10 VAutoTM) as Second-line Therapy: PoP IN VAuto
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obstructive Sleep Apnea
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2016-10-12
Enrollment: 30
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: Obstructive sleep apnea patient, non compliant or intolerant to Continous positive Airway Pressure therapy, treated by Bilevel Positive Airway Pressure (Aircurve 10 VAutoTM ) as second line therapy.

Brief summary: Prospective observational study of obstructive Sleep Apnea patients treated with Bilevel Positive Airway Pressure: AirCurve 10 VAutoTM

Detailed description: To characterize, in routine practice, non compliant patient to continuous positive airway pressure who can get a benefit of a bilevel positive airway pressure therapy as a second line treatment (Aircurve 10 VAutoTM ) To evaluate the clinical management of obstructive sleep apnea patients treated by Aircurve 10 VAutoTM , especially impact on compliance and residual apnea hypopnea Index.

To evaluate Aircurve 10 VAutoTM benefit on quality of Life and quality of sleep

Eligibility criteria: Inclusion Criteria:

* Adult patient
* Obstructive Sleep Apnea Patient previously treated by Continuous positive airway pressure non-compliant to therapy
* Patient naive of bilevel Positive Airway Pressure therapy

Exclusion Criteria:

* Bilevel positive airway pressure Contraindication
* Severe respiratory disease diagnostic

Primary outcomes:
measure: Compliance
timeFrame: 3 months
Secondary outcomes:
measure: sleepiness
timeFrame: 3 months
measure: sleep quality
timeFrame: 3 months
Other outcomes:
Locations:
city: Belfort
country: France
facility: CH de Belfort
city: Biarritz
country: France
facility: Clinique Aguilera
city: Blois
country: France
facility: Cabinet de Pneumologie
city: Lyon
country: France
facility: HCL - Croix-Rousse Hospital
city: Marseille
country: France
facility: APHM
city: Metz
country: France
facility: Centre médical du sommeil
city: Paris
country: France
facility: Hopital Saint Antoine
city: Rennes
country: France
facility: Polyclinique Saint-Laurent
Study officials:
affiliation: CHU Marseille
name: Alain Palot, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06146660: A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Official title: CAMZYOS® (Mavacamten) Post-Marketing Surveillance in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Hypertrophic Cardiomyopathy
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-11-27
Enrollment: 600
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants diagnosed with symptomatic oHCM who will receive mavacamten according to the approved product label

Brief summary: The purpose of this observational post-marketing surveillance study is to assess the real-world safety of mavacamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adult participants in Korea. Participants who will receive at least 1 dose of mavacamten will be enrolled.


Eligibility criteria: Inclusion Criteria:

* Adult participants 19 years of age or older
* Participants who receive mavacamten according to the approved product label
* Participants who sign the informed consent form

Exclusion Criteria:

* Participants who are prescribed mavacamten for therapeutic indications not approved in Korea
* Participants for whom mavacamten is contraindicated as clarified in Korean prescribing information approved by the Ministry of Food and Drug Safety

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0001
city: Seoul
country: Korea, Republic of
facility: Novotech Laboratory Korea Co., Ltd.
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01027260: Study to Evaluate the Role of Itopride HCI in Patients With Irritable Bowel Syndrome With Predominant Constipation
Official title: A Randomized, Placebo Controlled Study on the Efficacy of Itopride HCI on Irritable Bowel in Patients of Irritable Bowel Syndrome With Constipation (IBS-C)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-12-07
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients suffering from Irritable Bowel Syndrome with predominant constipation will be provided with the study medication. The study medication will be evaluated for its efficacy in relieving the symptoms


Eligibility criteria: Inclusion Criteria:

1. Male or female patient fulfilling the Rome III criteria for IBS-C
2. Signed informed consent at screening visit

Exclusion Criteria:

1. Patients having significant diarrhea at least 25% of the time during the past 3 months
2. Patients having alarm symptoms or signs
3. Chronic diarrhea
4. History of gastrointestinal haemorrhage, mechanical obstruction or perforation
5. Patient with clinically relevant ECG abnormalities (prolonged QT interval)
6. Active psychiatric disorder that would interfere with the study objectives
7. Health conditions (e.g. age related impairment of cognitive functions) that would interfere with the study objectives or might impair the compliance of the patient
8. Severe hepatic, renal, cardiac, metabolic, haematological or malignant diseases (including prolactin dependent tumours) or clinically relevant deviations in laboratory values (AST/ALT greater than twice the upper limit of normal, serum creatinine \* 2 mg/dl \[177 µmol/l\] according to the medical judgement of the investigator
9. Patient with hypokalemia (serum potassium \< 3.5 mmol/l).
10. History of any known hypersensitivity to the ingredients of the investigational drug
11. Pregnancy or lactation
12. Women with childbearing potential who do not apply a medically accepted method of contraception.

Primary outcomes:
measure: Patients will be asked a simple but well validated question "If there is a satisfactory relief of the symptoms"
timeFrame: 2 weeks and 4 weeks after the start of the treatment
Secondary outcomes:
measure: Subjects will be assessed based on Irritable Bowel Syndrome Severity Score (IBSSS).
timeFrame: 2 weeks and 4 weeks after the start of the treatment
measure: Safety based on the laboratory tests before and at the end of the treatment.
timeFrame: 4 weeks during the treatment period and 4 weeks following post- therapy period.
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Site Reference ID/Investigator# 5870
city: Karachi
country: Pakistan
facility: Site Reference ID/Investigator# 21441
city: Lahore
country: Pakistan
facility: Site Reference ID/Investigator# 6130
city: Rawalpindi
country: Pakistan
facility: Site Reference ID/Investigator# 8535
Study officials:
References:
Clinical trial NCT04480060: Experience of an Emergency Intensive Care Unit During COVID-19 Pandemic
Official title: Experience of an Emergency Intensive Care Unit During COVID-19 Pandemic: Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who followed up in emergency department ICU's of study centers with the diagnosis of COVID-19

Brief summary: COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Emergency departments also carried out an important part of the fight against pandemics in our country/Turkey. The emergency department including an intensive care unit is very few in this country/Turkey and the only hospital, which has an Emergency Intensive Care Unit (EICU) in Istanbul, is the study center. Therefore, this retrospective study aimed to provide useful information about how an effective EICU should be, especially how to use them during pandemic periods.

Detailed description: COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Emergency departments also carried out an important part of the fight against pandemics in our country/Turkey. The emergency department including an intensive care unit is very few in this country/Turkey and the only hospital, which has an Emergency Intensive Care Unit (EICU) in Istanbul, is the study center. Throughout the pandemic, many patients, including COVID-19 patients, were successfully followed up and discharged from EICU. With this study, the investigators expect to show the role of EICU during the pandemic. In addition, it will be seen that whether the patients, who are waiting for hospitalization or waiting for referral, are admitted to EICU faster and their treatments will be started promptly. Therefore, this retrospective study aimed to provide useful information about how an effective EICU should be, especially how to use them during pandemic periods.

Eligibility criteria: Inclusion Criteria:

* All patients who followed up in emergency department ICU with the diagnosis of COVID-19
* Accepted to participate with an informed consent

Exclusion Criteria:

* Patients under the age of 18 or more than 50 years
* declined to participate
* deaths caused by other than COVID-19

Primary outcomes:
measure: Mortality of the COVID-19 patients
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Seda Yilmaz Semerci
Study officials:
References: