louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03723109: Airway Management During TCI vs RSI Anesthesia Induction
Official title: Airway Management and Safety Aspects During Target Controlled Infusion (TCI) Compared to Rapid Sequence Induction (RSI) of Anesthesia in Non-cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Effect
Anesthesia
Airway Complication of Anesthesia
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive cohort, electively scheduled for breast cancer surgery, endocrinological surgery (thyroid, parathyroid) and minor general abdominal surgery.

Brief summary: The aims of this observational study is to evaluate and compare feasibility of airway management during standardized TCI and RSI anesthesia induction.

Detailed description: The aims of this study are to evaluate and compare feasibility of airway management and risk for desaturation during standardized target controlled infusion (TCI) and rapid sequence induction (RSI) of anesthesia. A conventional way to induce anesthesia, i.e. manual injection of anesthetics, may be more accurate and predictable compared to dosing regimes based on complex mathematical algorithms used in TCI-systems. In addition, today many different models are presented and there is no consensus which kind of TCI-algorithm should be used universally. Moreover, dosing algorithms are most complex and challenging in underweight and morbid obesity. There are many publications on this field, but no data of feasibility of airway management can be found. Indeed, RSI induction is traditionally blamed to be risky and not recommended as a first choice.

Eligibility criteria: Inclusion Criteria:

* signed informed consent
* BMI \< 35 kg/m2
* preoperative assessment accepted by consultant anesthesiologist
* scheduled for breast cancer surgery, endocrinological surgery (thyroid, parathyroid) or minor general abdominal surgery.

Exclusion Criteria:

* not signed consent
* instable angina pectoris
* severe bronchial asthma
* severe chronic obstructive pulmonary disease
* dementia
* severe heart valve disease
* severe renal failure
* body mass index \> 35 kg/m2

Primary outcomes:
measure: Safety time for apnea
timeFrame: 10min
Secondary outcomes:
measure: Duration of spontaneous breathing
timeFrame: 10min
Other outcomes:
Locations:
city: Luleå
country: Sweden
facility: Sunderby teaching hospital
Study officials:
affiliation: Umea University, senior lecturer
name: Tomi Myrberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03265509: Effect of Glutamine on Urinary Incontinence
Official title: Assessment of the Effect of Glutamine Supplementation in Addition to Exercise on Pelvic Floor Muscle Strength and Clinical Parameters in Women With Urinary Incontinence or Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Société des Produits Nestlé (SPN)
First posted: 2017-08-29
Enrollment: 50
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine to effect of additional oral glutamine to Kegel exercises on pelvic floor strength and clinical parameters of urinary incontinence in females with either urinary incontinence (stress and/or urgency) and pelvic prolapse.

Detailed description: Urinary incontinence is a prevalent and costly condition that affects approximately 38% of older community-dwelling women (age\>60 years). Incontinence predisposes patients to other health problems, contributes to depression and social isolation, is a significant source of dependency among the elderly, and is widely cited as a factor in nursing home admissions. Sarcopenia is age-related and is characterized by loss of muscle mass, strength and endurance. There is not only a decrease in the number of muscle fibers, but also atrophy in the remaining ones. Several studies indicate glutamine supplementations lead to better muscle performance by stimulate muscle producing in extremities. Similarly, we assume glutamine supplementation could increase pelvic muscle mass and improve the pelvic floor strength. From this point, using glutamine supplementation may effect positively on stress, urge or mixed incontinence, and pelvic prolapse.

Eligibility criteria: Inclusion Criteria:

* Presence of urinary incontinence and/or pelvic prolapse and/or decreased vaginal muscle strength in gynaecological examination

Exclusion Criteria:

* Uncontrolled diabetes
* Cognitive dysfunction hampering participation in exercise or assessment

Primary outcomes:
measure: Pelvic floor muscle strength with dynamometer
timeFrame: 3 months
measure: Pelvic floor muscle strength with digital palpation
timeFrame: 3 months
Secondary outcomes:
measure: body composition
timeFrame: 3 months
measure: quality of life related prolapse
timeFrame: 3 months
measure: general quality of life
timeFrame: 3 months
measure: 24 hour pad test
timeFrame: 3 months
measure: hand grip strength
timeFrame: 3 months
measure: urinary incontinence dairy
timeFrame: 3 months
measure: degree of prolapse
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Faculty of Medicine
Study officials:
affiliation: Istanbul University
name: Gulistan Bahat Ozturk, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06549309: Trial of JMKX003801 in Healthy Participants
Official title: A Phase I, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics of JMKX003801 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Tolerability
Pharmacokinetics
Lead sponsor: Jemincare
Sponsor class: INDUSTRY
First posted: 2024-08-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003801 Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Dose in Chinese Healthy Adult Participants


Eligibility criteria: Inclusion Criteria:

* The subjects have a thorough understanding of the study content, process, and potential adverse effects, and are willing to complete the study according to the requirements of the experimental protocol;
* Healthy adult males and/or females, 18 to 45 years of age;
* Body mass index (BMI) ≥ 19 and ≤ 28.0 (kg/m2) ,weight ≥45kg (female) or ≥50kg (male) .

Exclusion Criteria:

* Had or currently have serious clinical diseases related to circulatory system, respiratory system, digestive system, nervous system, endocrine system, blood lymphatic system, genitourinary system or psychiatry, or any other diseases judged by investigators that will be interference to the results of this study;
* Use of any over-the-counter (OTC) medication, prescription medicine, Chinese herbal medicine , within 2 weeks prior to the time of informed consent signed;
* Pregnant or lactating women;
* Other conditions unsuitable for the trial judged by the investigators.

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: From baseline to Day 3
Secondary outcomes:
measure: Serum concentrations of JMKX003801
timeFrame: From baseline to Day 3
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Jing Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03204656: Selective Bronchial Intubation (SBI)
Official title: Selective Bronchial Intubation (SBI) at Marie Lannelongue Hospital (HML) : Epidemiology of Expected and Unexpected Difficult Intubations.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Selective Bronchial Tube
Keywords: difficult orotracheal intubation
selective lung intubation
unexpected difficult selective lung intubation
Lead sponsor: Centre Chirurgical Marie Lannelongue
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients with intubation during surgery in Marie Lannelongue's hospital

Brief summary: Difficult orotracheal intubation carries a risk of hemodynamic collapse, neurological sequelae secondary to cerebral anoxia or death. Anesthetic scores and predictive indices are used to predict difficulties and avoid complications for usual tracheal intubation. However, existing indices are not adapted to selective bronchial intubations.

The aim of the study is to determine the incidence of unexpected difficult SBI using conventional screening tests. It is a prospective descriptive epidemiological monocentric study comparing two groups of patients (selective vs. non selective intubations).


Eligibility criteria: Inclusion Criteria:

* For adult patients : age greater than or equal to 18 years
* Patients with thoracic, cardiac, vascular or plastic surgery

Exclusion Criteria:

* Intubations performed before admission to the operating room or catheterization room;
* Patient whose age is less than 18 years
* Traditional re-intubation at the end of the procedure after a selective lung IOT;
* Selective re-intubation in a patient previously intubated on arrival at the operating theater;
* IOT in other departments of the HML (intensive care, Pulmonary Postoperative Unit (UPOP), bronchoscopy, hospitalization services, Intensive Care Unit (ICU), etc.).

Primary outcomes:
measure: Rate of difficult selective bronchial intubation
timeFrame: 1 day
Secondary outcomes:
measure: Predictive factors of difficult selective bronchial intubation
timeFrame: 1 day
Other outcomes:
Locations:
city: Le Plessis Robinson
country: France
facility: Hôpital Marie Lannelongue
Study officials:
References:
Clinical trial NCT03183856: Comparison of Ambulatory and Functional Improvement by Morning Walk
Official title: Comparison of Clinical Efficacy and Safety for Ambulatory and Functional Improvement in Patients After Total Knee Arthroplasty With Morning Walk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Robotics
Lead sponsor: Ulsan University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
First posted: 2017-06-12
Enrollment: 9
Sex: ALL
Standard ages: CHILD
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 the clinical efficacy and feasability of gait rehabilitation robot through approving functional improvement by an end-effector typed gait robot in patients underwent total knee arthroplasty.

Detailed description: pre-interventional evaluation; within 1 day of initiation of the intervention; 5 days after initiation of the intervention; 10 days after intervention after initiation of the intervention; 42 days after intervention start

Eligibility criteria: Inclusion Criteria:

* Patients underwent Unilateral or both Total Knee Arthroplasty

Exclusion Criteria:

* brain disease, spinal cord injury, peripheral neuropathy, myopathy
* Inability to ambulate fully due to muscukoskeletal disorders
* MMSE\<23
* history of arthroplasty surgery on either of legs
* Cardiac pacemaker
* Refusal of participation

Primary outcomes:
measure: Change of WOMAC index
timeFrame: 1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention
Secondary outcomes:
measure: Change of VAS
timeFrame: 1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention
Other outcomes:
measure: Change of ROM
timeFrame: 1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention
measure: Change of drug consumption
timeFrame: 5 day, and 10 day after the initiation of intervention
measure: Change of 6 minute walk test
timeFrame: 1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Ulsan University Hospital
name: Chang Ho Hwang, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05731856: Impact of Heart Rate Variability Modulation on Stress Management Among Physicians
Official title: Impact of Heart Rate Variability Modulation on Stress and Recovery Among Physicians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Professional
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: The Board of Medicine
name: Apollo Neuroscience, Inc.
First posted: 2023-02-16
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single group study. All participants will receive identical instructions regarding the device and will complete the same survey measures.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research is to examine a wearable device called Apollo that emits gentle vibrations found to benefit mood, energy, and focus. We want to understand how it affects burnout in physicians.

Detailed description: This study will be conducted by using a Tuned Vibroacoustic Stimulation (TVS) device(the commercially available TVS device known as the Apollo wearable), that has been shown in clinical studies at University of Pittsburgh to improve heart rate variability and recovery under stress. The Apollo wearable generates low volume sound waves that feel like a soothing touch to the skin. This study will assess whether slight modulation of heart rate variability (HRV) will result in a reduction in stress, improved recovery, and recovery in and around the hospital. Physicians will wear the Apollo device for heart rate variability modulation and complete questionnaires before and after use of the Apollo device for comparison of outcomes.

Eligibility criteria: Inclusion Criteria:

* UPMC attending physicians and residents. The participants must have either IOS or Android phones.

Exclusion Criteria:

* Unwillingness or inability to participate in the study
* Currently own an Apollo device

Primary outcomes:
measure: Copenhagen Burnout Inventory
timeFrame: Through study completion, on average 8 weeks
measure: Perceived Stress Scale (PSS-10)
timeFrame: Through study completion, on average 8 weeks
Secondary outcomes:
measure: The Quick Inventory of Depressive Symptomatology
timeFrame: Through study completion, on average 8 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Through study completion, on average 8 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Michelle Thompson, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01632956: Developing Culturally-Tailored Information-Based Support Groups for Chinese Immigrants With Breast Cancer
Official title: Developing Culturally-Tailored Information-Based Support Groups for Chinese Immigrants With Breast Cancer: A Pilot Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chinese Immigrants With Breast Cancer
Keywords: Support Groups
Breast cancer
Mandarin speaking
12-105
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Cancer Support Community
name: CHARLES B WANG COMMUNITY HEALTH CENTER
name: Queens Health Network
First posted: 2012-07-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recruitment will be conducted by the MSKCC Research Study Assistant (RSA) with the assistance of the treatment team and community partners. Patients of MSKCC and QCC will be approached in clinic waiting rooms by the RSA. ACS Asian Initiatives and the Charles B Wang Community Health Center are referral sites for this study.

Brief summary: There are few breast cancer support groups that focus on the specific needs of Chinese women. The purpose of this study is to learn about two different ways of providing support groups to help women of Chinese descent cope with the difficulties of a diagnosis of breast cancer and its treatment. The investigators want to learn about how best to support Chinese women with breast cancer by providing two different types of groups: an in-person support group and a virtual (online/phone) support group.


Eligibility criteria: Inclusion Criteria:

* Female
* Non-US born
* Resident in the US \< 20 years
* Of Chinese descent
* Age 21 years through 80 years
* Language spoken: Mandarin
* Diagnosis of breast cancer within 3 months prior to recruitment

  \*Not required that breast cancer is the patients' first and/or only cancer diagnosis
* Currently receiving cancer treatment;
* Will be living continuously in the US for the next year
* Has a telephone that he/she is willing to use for the study

Exclusion Criteria:

* Presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection
* Another household member is already enrolled.
* Prior participation in a cancer support group

Primary outcomes:
measure: feasibility
timeFrame: 1 year
Secondary outcomes:
measure: To compare the impact of participation
timeFrame: 1 year
measure: To assess satisfaction with the support groups
timeFrame: 1 year
measure: To assess Internet use
timeFrame: 1 year
Other outcomes:
Locations:
city: Jamaica
country: United States
facility: Queens Cancer Center of Queens Hospital
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jennifer Leng, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03807856: Treating Acute Pancreatitis With Dabigatran, a Pilot Study
Official title: Treating Acute Pancreatitis With Dabigatran, a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Acute Pancreatitis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 2
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: Researchers are studying the safety and efficacy of Dabigatran in the treatment of acute pancreatitis.

Detailed description: Subjects with acute pancreatitis who meet the inclusion and exclusion criteria for the study will be recruited. Subjects will be randomized to receive either Dabigatran 150mg daily for three days or standard treatment. Vital signs, CBC, inflammatory markers and BMP, and bleeding complications will be evaluated daily for the next 7 days of until discharge whichever is sooner.

Eligibility criteria: Inclusion Criteria:

* Acute Pancreatitis (presence at least two of three features: typical pain, amylase or lipase \>3 times UNL and AP on images)
* 18-75 years old
* Willingness to sign the informed consent
* Symptom onset within 72 hours

Exclusion Criteria:

* Under 18 years of age or over 75 years of age
* Pregnancy or lactating
* Presence of pseudo aneurysm on CT
* Predicted severe acute pancreatitis
* Unwilling or unable to sign the informed consent
* Had recent surgery or sphincterotomy
* Active pathological bleeding
* Concurrent use of anti-coagulation
* Known serious hypersensitivity reaction to Dabigatran
* CrCI \<30mL/min or on dialysis
* Mechanical prosthetic valves
* Liver disease
* Cancer
* On Chemotherapy or immunosuppressant
* Persistent ALT, AST, Akl Phos \>2 x ULN
* Active hepatitis C, active hepatitis B, and active hepatitis A
* Anemia (hemoglobin \<10g/dL)
* Thrombocytopenia
* Concomitant use of P-gp inhibitors

Primary outcomes:
measure: Adverse Events
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Yan Bi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01413256: Allergenic Effect of Ambrosia in Israel
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allergy
Ambrosia
Ragweed
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-08-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: respiratory allergic patients

Brief summary: Background:

Respiratory allergic reaction causes great suffering to millions of people worldwide. One of the most known allergen- is the pollen from vegetation, ragweed. Genus Ambrosia Ambrosia belonged to the complex ragweed flowers are pollinated by the wind and the plant's male flowers produce large quantities of small grains of pollen and airborne over long distances and those causes allergic reactions. The plant blooms between June and October, creating a second wave after wave of allergy caused by spring blossoms.

This plant originated in North America has invaded many areas in Europe and in recent years, taking over large areas in Israel, Hula Valley and northern Acre Emek Hefer for a pen and layers to the south. After ragweed plants are based in particular they spread quickly and invade agricultural fields and significantly reduce the crop.

High allergenic ragweed is a health hazard to humans. Ragweed plant investigated many aspects of North America and Europe in recent decades and extensive literature on ambrosia, but this is the first time ragweed study focuses on Israel.

Working hypothesis and aims:

Goal of this study is to identify the existence and nature of the sensitivity distribution of ragweed in Israel.

Importance of research:

A. Ragweed allergen testing and comparing the effect of exposure to plants on the sensitivity of the allergic Israeli patients

B. The inclusion of ragweed allergen in the diagnostic and therapeutic panel


Eligibility criteria: Inclusion Criteria:

* respiratory allergic patients

Exclusion Criteria:

* non respiratory allergic patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: