louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01709422: Efficacy and Safety Profiles of Combination Sedation Propofol With Midazolam and Meperidine.
Official title: Efficacy and Safety Profiles of Sedation With Propofol Combined With Intravenous Midazolam and Meperidine Versus Intravenous Midazolam and Meperidine for Ambulatory Endoscopic Retrograde-cholangiopancreatography(ERCP).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Disorders of Gallbladder, Biliary Tract and Pancrease
Keywords: Propofol
Midazolam
Meperidine
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2012-10-18
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare efficacy and safety of combination of propofol and midazolam with meperidine versus midazolam and meperidine for ambulatory ERCP

Detailed description: ERCP is commonly done under sedation with midazolam and meperidine, however some studies showed varying outcomes of this conventional sedation for maintained sedation. Propofol is increasing used for sedation in gastrointestinal procedure owing to its rapid recovery profiles but the complications associated with propofol are not negligible.The investigators prospectively compare the efficacy, induction time, recovery time, patient satisfaction and side effect between propofol based and conventional sedations in patients undergoing ERCP.

Eligibility criteria: Inclusion Criteria:

. All outpatients aged more than 18 years who were schedule for ERCP -

Exclusion Criteria:

* pregnant woman
* emergency situation ( i.e. concomitant upper gastrointestinal bleeding, acute cholangitis )
* American Society of Anesthesiologist ( ASA )Class IV or V
* respiratory disease,
* sleep apnea
* allergy to egg or soybean
* drug abuse( benzodiazepine, opioid agonist )
* previous history of failure sedation

Primary outcomes:
measure: Procedure Related Time
timeFrame: participants will be followed for the duration of procedure, an expected average of 2.0 hours ]
Secondary outcomes:
measure: Cardiovascular Adverse Events.
timeFrame: participants will be followed for the duration of procedure, an expected average of 2.0 hours
Other outcomes:
Locations:
city: Hatyai
country: Thailand
facility: NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University
state: Songkhla
Study officials:
affiliation: NKC Institute of Gastroenterology and Hepatology, Prince of Songklanakarind University
name: Nisa Netinatsunton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Prince of Songkla University
name: Nisa Netinatsunton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03619122: Second Forward View Examination of Proximal Colon on Adenoma Detection Rate
Official title: Impact of Second Forward View Examination of Proximal Colon on Adenoma Detection Rate: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Adenoma
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 392
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: SCREENING

Brief summary: This clinical trial is being conducted to assess whether second forward view examination of proximal colon could increase adenoma detection rate of right colon.


Eligibility criteria: Inclusion Criteria:

* all patients undergoing colonoscopy for screening in our hospital

Exclusion Criteria:

* previous history of resection of colon;
* familial polyposis syndrome
* inflammatory bowel disease
* active antiplatelet or anticoagulant therapy prevent polypectomy;
* pregnancy or lactating women

Primary outcomes:
measure: per-patient detection rate of adenoma of proximal colon
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo NO.1 hospital
state: Zhejiang
Study officials:
References:
citation: Shan K, Lu H, Zhang Z, Xie J, Xu L, Wang W, Hu C, Xu L. Impact of second forward-view examination on adenoma detection rate during unsedated colonoscopy: a randomized controlled trial. BMC Gastroenterol. 2021 May 10;21(1):213. doi: 10.1186/s12876-021-01783-9.
Clinical trial NCT01927822: Factors Influencing the Abortion Interval of Second-trimester Termination of Pregnancy Using Misoprostol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labor Induction
Keywords: termination of pregnancy, abortion
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2013-08-23
Enrollment: 101
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a single-center, retrospective chart review study. All female patients who were admitted for medical termination of second-trimester pregnancy from January 2008 to May 2013, at the Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital were recruited.

Brief summary: This study aims to analyze the factors influencing the abortion interval of second-trimester termination of pregnancy using misoprostol.

Detailed description: Misoprostol is the primary drug of choice for medical termination. It is not only cheap, but also stable at room temperature and easily available worldwide. It is indicated for the treatment of gastritis, but is widely used off-label for a variety of indications in the practice of obstetrics and gynecology, including medication abortion, induction of labor, and the treatment of postpartum hemorrhage. The optimal dosage and route of administration have not been well defined and vary with physicians. The potency of misoprostol's effect varies with dosage, route of administration and dosing interval; both maternal and fetal factors may, to certain extent, affect the abortion interval. This study aims to analyze the factors influencing the abortion interval of second-trimester termination of pregnancy using misoprostol.

Eligibility criteria: Inclusion Criteria:

1.All female patients who were admitted for medical termination of second-trimester pregnancy

Exclusion Criteria:

1. Patients who are allergy to Cytotec.

Primary outcomes:
measure: Successful termination rate by Cytotec.
timeFrame: 1 week
Secondary outcomes:
measure: Factors affecting abortion interval by cytotec.
timeFrame: 1 week
Other outcomes:
Locations:
city: New Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Sheng-Mou Hsiao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00581022: Objective Sleep Disturbances in Orthostatic Intolerance
Official title: Assessment of Objective Sleep Disturbances in Orthostatic Intolerance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postural Tachycardia Syndrome
Chronic Orthostatic Intolerance
Keywords: postural tachycardia syndrome
sleep
insomnia
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2007-12-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with chronic orthostatic intolerance by the Vanderbilt Autonomic Dysfunction Center

Brief summary: We wish to study sleep architecture in patients with chronic orthostatic intolerance. We will test the null hypothesis that there is no difference in time during the various phases of sleep between patients and healthy control subjects.


Eligibility criteria: Inclusion Criteria:

* diagnosed with chronic orthostatic intolerance (or healthy subject)

Exclusion Criteria:

* overt cause or acute orthostatic intolerance
* pregnancy or lactation

Primary outcomes:
measure: Duration of sleep
timeFrame: 1 night
Secondary outcomes:
measure: Time in individual phases of sleep
timeFrame: 1 night
measure: sleep latency
timeFrame: 1 might
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Unviersity
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Satish R Raj, MD MSCI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02074722: Brain-Computer Interface and Mind-Body Awareness Training
Official title: Brain-Computer Interface and Mind-Body Awareness Training
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Subjects
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2014-02-28
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy population in Minneapolis area

Brief summary: Mind-Body Awareness Training (MBAT), in the forms of various yoga and meditative practices, has become increasingly prevalent due to an increase in awareness of the potential health benefits, and improvements in concentration that this training can provide to practitioners. In the present study, we investigate the role of Mind-Body Awareness Training (MBAT) in the initial learning of a sensorimotor (SMR) based Brain-Computer Interface (BCI).

The PI's hypothesis is that MBAT will improve performance in SMR based BCI.

Detailed description: In this protocol, we will test the PI's hypothesis that MBAT including yoga will improve the ability for subjects to concentrate on control the SMR thus improving the performance of BCI.

Subjects will be recruited for short term MBAT and then undergo BCI training. The performance of subjects with MBAT will be compared with those without MBAT to test the hypothesis. Procedures involved include 6 weeks yoga classes with at least 3 classes per week, and a EEG brain noninvasive brain computer interface study.

Eligibility criteria: Inclusion Criteria:

* 18-64 years old healthy subjects

Exclusion Criteria:

* History of traumatic brain injury/brain lesion, history of neurological deficit or neurodegenerative disorder, or history of epileptic seizures.

Primary outcomes:
measure: Performance over BCI sessions
timeFrame: one to three months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Nils Hasselmo Hall at the University of Minnesota - Twin Cities Campus
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Bin He, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00634322: High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma
Official title: Randomized, Blinded, Placebo-Controlled Trial of High Dose Methotrexate With Leucovorin Rescue (HDMTX-LV) With or Without Glucarpidase in Osteosarcoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Osteosarcoma
Keywords: osteosarcoma
high dose methotrexate
leucovorin
Lead sponsor: BTG International Inc.
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2008-03-13
Enrollment: 7
Sex: ALL
Minimum age (years): 8
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate whether use of glucarpidase facilitates administration of the next cycle of chemotherapy as scheduled and improves safety and tolerability of HDMTX given with LV


Eligibility criteria: Inclusion Criteria:

* osteosarcoma
* eligible to receive 2 sequential cycles of HDMTX-LV

Exclusion Criteria:

* prior administration of glucarpidase
* progression of disease while on previous MTX treatment

Primary outcomes:
measure: Patients Progressing to Next Chemotherapy Cycle
timeFrame: 1 week after intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Pete Anderson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04347122: Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction
Official title: Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Musculoskeletal Cancer
Sarcoma,Soft Tissue
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to one of four groups. One group is the bony tumor treated with TXA, second group is the bony tumor treated without TXA, third group is the soft tissue sarcoma treated with TXA, and the fourth group is soft tissue sarcoma treated without TXA.
Primary purpose: TREATMENT

Brief summary: This study intends to determine if any correlation exists between administration of TXA or not to musculoskeletal oncology patients undergoing endoprosthetic reconstruction and blood loss and blood transfusion rates.

Detailed description: Resection of bony and soft tissue tumors with endoprosthetic reconstruction often presents a significant risk of perioperative blood loss requiring transfusion. Tranexamic acid (TXA) is an antifibrinolytic that is commonly used to reduce blood loss in orthopedic procedures, most often arthroplasty. The aim of this study is to determine in a randomized controlled fashion if there is any difference in perioperative blood loss and blood transfusion rates when TXA is used compared to when it is not used in patients undergoing radical resection of bone and soft tissue sarcomas with endoprosthetic reconstruction.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing wide resection of a malignant bony tumor of the lower extremity with endoprosthetic reconstruction.
* Patients undergoing a resection of soft tissue sarcoma measuring \> 5cm.

Exclusion Criteria:

* Patients undergoing revision endoprosthetic reconstruction
* Patients with known coagulopathy
* Known history of DVT or embolic disease
* Benign tumors
* Patients with allergy to TXA
* Those refusing blood products
* Those concurrently on anti-coagulant therapy
* Pregnant and/or nursing women
* Vulnerable populations as defined by the KUMC IRB

Primary outcomes:
measure: Perioperative Blood Loss
timeFrame: During surgical procedure, 4 to 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Kyle Sweeney, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01842022: The Effect of the Glycemic Load of Meals on the Cognition and Mood of Older Adults
Official title: The Effect of the Glycemic Load of Meals on the Cognition and Mood of Older Adults With Differences in Glucose Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Glycemic load
memory
mood
Lead sponsor: Swansea University
Sponsor class: OTHER
First posted: 2013-04-29
Enrollment: 155
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A lower rather than a higher glycemic load (GL) meal has been shown to benefit cognition and mood, however, the data in older adults and those most prone to cognitive dysfunction, is limited and conflicting. One explanation is that the GL of a meal may interact with a person's pre-existing glucose tolerance (GT).

As older adults have a higher incidence of glucose tolerance and are more likely to experience memory problems the present study considers the interaction between the GL of meal in those with better or poorer GT.

The population studied will not have a history of diabetes or dementia. A battery of cognitive tests will be administered after meals sweetened with one of three sugars known to vary in the rate that they release glucose into the blood stream.

Detailed description: On day one subjects will take an oral glucose tolerance test and will then be divided into four groups depending on their glucose tolerance (how long values remain raised) and the tendency for values to subsequently fall to low values.

On a second occasion 155 healthy older adults, aged 45-80 years, will be randomly assigned to receive either a glucose, sucrose or isomaltulose based meal. All meals are matched on macronutrient composition and differ only in glycemic load. Cognitive performance and mood will be assessed 30, 105 and 180 minutes after breakfast. Measures of memory, attention, reaction times and mood will be taken.

The response to the three meals will be contrasted in those with different glucose profiles on day one

Eligibility criteria: Inclusion Criteria:

* Healthy adults of 45 to 80 years

Exclusion Criteria:

* Type 1 or type 2 diabetes
* Dementia
* Liver disease
* Gastro-intestinal problems

Primary outcomes:
measure: Change in episodic memory
timeFrame: 30, 105, 180 minutes
Secondary outcomes:
measure: Change in mood
timeFrame: 30, 105, 180 minutes
Other outcomes:
measure: Change in reaction Times
timeFrame: 30, 105, 180 minutes
measure: Change in vigilance
timeFrame: 30, 105 and 180 minutes
Locations:
city: Swansea
country: United Kingdom
facility: Psychology, Swansea University
state: Wales
Study officials:
affiliation: Swansea University
name: David Benton, DSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01773122: Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-01-23
Enrollment: 77
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of dapsone in subjects with acne vulgaris following 28 days of dosing.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of acne vulgaris
* Willing to avoid excessive or prolonged exposure to ultraviolet light (e.g., sunlight, tanning beds) throughout the study
* If male, the subject must agree to shave the facial treatment area and agree to maintain his routine shaving regimen for the duration of the study
* willing to avoid applying moisturizers, sunscreens, cosmetics (except eye and lip makeup), and chemical peels throughout the study

Exclusion Criteria:

* Oral acne treatments within 6 months

Primary outcomes:
measure: Maximum Plasma Level (Cmax) of Dapsone
timeFrame: Day 28
Secondary outcomes:
measure: Maximum Plasma Level (Cmax) of Dapsone Metabolites
timeFrame: Day 28
Other outcomes:
Locations:
city: College Station
country: United States
state: Texas
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Jarratt MT, Jones TM, Chang-Lin JE, Tong W, Berk DR, Lin V, Kaoukhov A. Safety and Pharmacokinetics of Once-Daily Dapsone Gel, 7.5% in Patients With Moderate Acne Vulgaris. J Drugs Dermatol. 2016 Oct 1;15(10):1250-1259.
Clinical trial NCT02642822: The Epidemiologic Study of Human Cytomegalovirus（CMV） in Female Students of Xiamen University
Official title: The Epidemiologic Study of Human Cytomegalovirus （CMV）in Female Students of Xiamen University
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cytomegalovirus Infections
Keywords: Cytomegalovirus
Lead sponsor: Xiamen University
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 female students aged 18 to 30 years old will be recruited from Xiamen University.

Brief summary: In this study, 100 female students aged 18 to 30 years old in Xiamen University will be enrolled. On the first visit, blood, saliva and urine samples of all participants will be collected. Then saliva and urine samples will be collected at two-week interval until 6 months. Serum samples will be tested the PP150-IgG titer. Saliva and urine samples will be used to test CMV DNA by PCR. The primary purpose of this study is to identify the relationship between baseline PP150-IgG titer and CMV infection.


Eligibility criteria: Inclusion Criteria:

* 18-30 years old
* female students of Xiamen University

Exclusion Criteria:

* students who have the serious diseases

Primary outcomes:
measure: rate of active CMV infection in different PP150-IgG titer
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Xiamen
country: China
facility: School of public health of Xiamen University
state: Fujian
Study officials:
References:
Clinical trial NCT01181622: A Safety and Tolerability Study of Denufosol in 2-4 Year Olds
Official title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 7-Day Safety and Tolerability Study of Denufosol Tetrasodium Inhalation Solution Administered Via PARI LC® Star in Patients 2 to 4 Years of Age With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-08-13
Enrollment: 25
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of denufosol 60 mg TID in pediatric CF patients 2 to 4 years of age


Eligibility criteria: Inclusion Criteria:

* Have a confirmed diagnosis of CF
* Have oxyhemoglobin saturation ≥ 95% prior to randomization

Exclusion Criteria:

* Have acute intercurrent respiratory infection (cough, wheezing, or new

rhinorrhea or nasal congestion)

* Have any significant medical condition not related to CF
* Unable to discontinue use of hypertonic saline

Primary outcomes:
measure: Intolerability to study drug as measured by: oxyhemoglobin saturation, treatment-emergent cough, and new wheezes or crackles
timeFrame: Day 1, Day 7
Secondary outcomes:
measure: Mean change from pre-dose in oxyhemoglobin saturation at defined times post-dose
timeFrame: Day 1, Day 7
measure: Mean change from baseline in oxyhemoglobin saturation
timeFrame: Day 7
measure: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and/or withdrawals due to TEAEs
timeFrame: Day 7
measure: Mean change from pre-dose in pulse and respiratory rate at defined times post-dose
timeFrame: Day 1, Day 7
measure: Mean change from baseline in pulse and respiratory rate
timeFrame: Day 7
measure: Incidence of new medical condition(s) or worsening of previous medical condition(s) from baseline
timeFrame: Day 7
Other outcomes:
Locations:
Study officials:
affiliation: Medical monitor
name: Lynn Smiley, MD
role: STUDY_DIRECTOR
References: