louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01546259: Water Method in Low-body Mass Index (BMI) Female Patients With Unsedated Colonoscopy
Official title: Water Method With Water Exchange Versus Air Insufflation in Low-BMI Female Patients Undergoing Unsedated Colonoscopy: a Prospective Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Adenoma
Pain
Keywords: colonoscopy
water
female
BMI
unsedated
low BMI female patients
Intubation
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Water method with water exchange has been shown to reduce medication requirement and pain experienced during colonoscopy. It increases the success rate of cecal intubation in sedated and unsedated patients undergoing screening colonoscopy. Exchange of water during scope insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion of air from the colon during insertion by omission of air insufflations and suction removal of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy insertion in average patients and may enhance the success of difficult colonoscopy.

Female gender and low-body mass index (BMI) is independently associated with incomplete colonoscopy, respectively. The investigators postulate that low-BMI female patients may benefit from using the water method for colonoscopy. In this proposal the investigators test the hypothesis that compared with conventional air insufflations the water method with water exchange significantly enhances the success rate of cecal intubation in low-BMI female patients.

The aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in low-BMI female patients. The primary outcome is cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.


Eligibility criteria: Inclusion Criteria:

* Female patients with BMI \< 20

Exclusion Criteria:

* History of colorectal surgery
* Severe colonic stricture or obstructing tumor
* Patients who cannot give informed consent and those who are hemodynamically unstable

Primary outcomes:
measure: Cecal intubation success rate
timeFrame: up to two years
Secondary outcomes:
measure: Adenoma detection rate
timeFrame: up to two years
measure: Pain Scores on the Visual Analog Scale
timeFrame: up to two years
measure: Cecum intubation time
timeFrame: up to two years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Endoscopic center, Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Yanglin Pan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02440659: Empowering Patients on Choices for Renal Replacement Therapy (Aim 2)
Official title: Empowering Patients on Choices for Renal Replacement Therapy (Aim 2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Hemodialysis
Peritoneal Dialysis
Lead sponsor: Arbor Research Collaborative for Health
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Henry Ford Health System
name: National Kidney Foundation, United States
name: American Association of Kidney Patients
name: Patient-Centered Outcomes Research Institute
First posted: 2015-05-12
Enrollment: 2946
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients currently consented in the Dialysis Outcomes and Practice Patterns Study (DOPPS) or the Peritoneal Outcomes and Practice Patterns Study (PDOPPS).

Brief summary: Empowering Patients On Choices for Renal Replacement Therapy (EPOCH-RRT) study seeks to identify factors that matter the most to patients with kidney disease and study how they are impacted by different types of dialysis. The inclusion of patients, caregivers, and patient advocacy organizations as research partners will assure that the study addresses questions of greatest relevance to patients facing the need for dialysis.

Aim two is based on preliminary results of Aim one interviews, and in collaboration with the Patient Advisory Panel, the investigators developed a brief questionnaire to be administered to participants in the Dialysis Outcomes and Practice Patterns Study (DOPPS) and Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS). Two separate versions of the questionnaire were created to reflect unique aspects of in-center hemodialysis (HD) and peritoneal dialysis (PD).


Eligibility criteria: Inclusion Criteria:

* Individuals 18 years of age or older.
* Currently consented in the Dialysis Outcomes and Practice Patterns Study - (DOPPS) or the Peritoneal Outcomes and Practice Patterns Study (PDOPPS).

Exclusion Criteria:

* Individuals under 18 years of age.
* Individuals unable to provide informed consent.

Primary outcomes:
measure: Patient's Quality of Life
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Arbor Research Collaborative for Health
state: Michigan
Study officials:
affiliation: Arbor Research Collaborative for Health
name: Francesca Tentori, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02803359: Investigation of Human Laryngeal Evoked Brainstem Potentials
Official title: Investigation of Human Laryngeal Evoked Brainstem Potentials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroidectomy
Keywords: Laryngeal evoked brainstem response (LEBR)
laryngopharyngeal sensory discrimination testing (LPSDT)
brainstem activity
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The primary purpose of this study will be to determine whether the proposed study protocol will allow for reliable detection of the human Laryngeal evoked brainstem responses (LEBR). Laryngeal evoked brain stem responses will be recorded from five test subjects under general anesthesia in the operating room with the assistance of an electrophysiologist with expertise in evoked potentials. Once the feasibility of obtaining tracings are established on the first few subjects, responses will be recorded from other test subjects with the aim of determining the optimal placement of stimulating electrodes and detection leads necessary to elicit an adequate response. The effect of varying the stimulus intensity will also be studied. Once parameters for testing have been standardized, normative configurations for the laryngeal evoked brainstem response tracings can be determined by patients both in the office setting and in the operating room.


Eligibility criteria: Inclusion Criteria:

* Healthy Subjects undergoing thyroid or other open neck surgeries

Exclusion Criteria:

* Current or recent (within one month) tracheostomy
* Vocal cord paralysis
* History of Stroke
* History of Diabetes Mellitus
* History of Neurologic Disease
* History of Radiation to the Neck
* History of Brain Surgery
* History of Neck Surgery
* Recent Laryngeal Surgery (within one month)
* Recent Intubation (within two weeks)
* Laryngopharyngeal Reflux Disease
* Allergy to Lidocaine
* Allergy to Oxymetazoline

Primary outcomes:
measure: analysis of variance in brain auditory evoked response (BAER) measured using recording electroencephalography electrodes
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Milan Amin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03120559: Improving Dental Floss Adherence and Gingival Health With SMS and an Innovative Floss Holder
Official title: Can we Still Save Dental Floss? Improving Dental Floss Adherence and Gingival Health With SMS and an Innovative Floss Holder in a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior
Gingivitis
Keywords: Gingivitis
SMS
Dental floss
behavior change
HAPA
Lead sponsor: University of Lisbon
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study proposes to evaluate the effects of using a new floss holder (GumChuck) and the use of text messages during supportive periodontal therapy, on the psychological, behavioral and clinical parameters of patients with gingivitis, outlined by evidence and a theory-based framework.

Detailed description: Despite evidence on the benefits of controlling dental biofilm for preventing gingivitis, patients have difficulty complying. Floss holder devices and SMS may be useful in enhancing both the frequency and effectiveness of dental hygiene behaviors, by increasing patients' motivation and self-regulation efforts, but scarce scientific literature supporting their worth in controlling gingivitis and the underlying psychological processes is currently available.

Eligibility criteria: Inclusion Criteria:

* Gingivitis BOMP \> 0.5
* 20 teeth (minimum 5 per quadrant)
* \> 18 years old

Exclusion Criteria:

* periodontitis (pockets \>3),
* smoking,
* orthodontics,
* pregnancy
* removable partial dentures

Primary outcomes:
measure: Change from BOMP (Bleeding on Marginal Probing) at 4 months
timeFrame: Baseline & 4 months
Secondary outcomes:
measure: HAPA behavioral variables questionnaire.
timeFrame: Baseline & 4 months
measure: SMS opinion questionnaire
timeFrame: 4 months
measure: Self-report Dental Hygiene Behaviors questionnaire.
timeFrame: Baseline & 4 months
Other outcomes:
Locations:
Study officials:
References:
citation: Van der Weijden GA, Timmerman MF, Nijboer A, Reijerse E, Van der Velden U. Comparison of different approaches to assess bleeding on probing as indicators of gingivitis. J Clin Periodontol. 1994 Oct;21(9):589-94. doi: 10.1111/j.1600-051x.1994.tb00748.x.
Clinical trial NCT01550159: Correlation Between Markers of Neuronal Injury and Cognitive Dysfunction After Coronary Artery Bypass Surgery
Official title: Study of Correlation Between Serum Levels of Markers of Neuronal Injury and Cognitive Dysfunction After Coronary Artery Bypass Graft Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Cognitive Dysfunction
Keywords: Postoperative Cognitive Dysfunction
Cardiac Surgery
General Anesthesia
Neuropsychological Tests
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2012-03-09
Enrollment: 88
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients underwent for coronary artery bypass graft surgery.

Brief summary: This study aims to evaluate the possible Correlation Between Serum Levels of Markers of Neuronal Injury and Cognitive Dysfunction after Coronary Artery Bypass Surgery.

Detailed description: The systemic inflammatory response after cardiac surgery may cause damage to the central nervous system and elevated markers of brain injury in peripheral blood. This event may be potentially related to the development of postoperative cognitive dysfunction (POCD), with incidences varying from 20 to 83%.

Eligibility criteria: Inclusion Criteria:

* Patients underwent for coronary artery bypass graft surgery

Exclusion Criteria:

* History of brain disease or dementia, other psychiatric disorders that affect cognition
* Lack of proficiency in Portuguese language

Primary outcomes:
measure: Score in Neuropsycological Tests
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: General Hospital of the University od São Paulo Medical School
Study officials:
affiliation: University of Sao Paulo Medical School
name: Maria JC Carmona, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silva FP, Schmidt AP, Valentin LS, Pinto KO, Zeferino SP, Oses JP, Wiener CD, Otsuki DA, Tort AB, Portela LV, Souza DO, Auler JO Jr, Carmona MJ. S100B protein and neuron-specific enolase as predictors of cognitive dysfunction after coronary artery bypass graft surgery: A prospective observational study. Eur J Anaesthesiol. 2016 Sep;33(9):681-9. doi: 10.1097/EJA.0000000000000450.
Clinical trial NCT04124159: Risk of Recurrent Venous Thromboembolism After Provoked Venous Thromboembolism
Official title: Risk of Recurrent Venous Thromboembolism in Patients With Provoked Deep Vein Thrombosis of the Leg and/or Pulmonary Embolism: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recurrent Venous Thrombosis
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2019-10-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive patients with a deep vein thrombosis and/or pulmonary embolism provoked by a transient risk factor after a minimum of 3 months of anticoagulation

Brief summary: Venous thromboembolism (VTE) is a common disease with an incidence of 1-2/1000 persons per year. VTE is a chronic disease with a considerable risk of recurrence. Patients with unprovoked VTE, i.e. VTE in the absence of a temporary risk factor including surgery, cancer or immobilisation, have a high recurrence risk and indefinite anticoagulation is generally recommended. The recurrence risk of patients with VTE provoked by a transient risk factor is regarded as low. Discontinuation of anticoagulation after three months is recommended because the benefit of reducing the recurrence risk further by prolonged anticoagulation is outweighed by the bleeding risk. However, the newer direct oral anticoagulants are potentially associated with a lower bleeding risk than vitamin K antagonists. Because they are also meanwhile widely available and are convenient there is a trend towards prolonging anticoagulation also in patients with a VTE after a transient provoking factor. However, the definition of transient provoking factors is imprecise and a distinct categorization according to the risk of recurrence is lacking. Preliminary evidence suggests that the recurrence risk varies considerably between the different transient provoking factors. In a prospective cohort study, the investigators will include patients with a deep vein thrombosis or pulmonary embolism provoked by a transient risk factor defined according to Guidance of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis (Kearon et al., J Thromb Haemost 2016; 14: 1480-3) after discontinuation of anticoagulation. The study endpoint is recurrent symptomatic VTE.


Eligibility criteria: Inclusion Criteria:

* Symptomatic uni- or bilateral proximal or distal deep vein thrombosis of the leg and/or symptomatic pulmonary embolism provoked by a temporary risk factor
* Scheduled to be treated with anticoagulants for at least 3 months

Exclusion Criteria:

* Need for long-term anticoagulation
* Poor patient compliance
* No consent to participate
* VTE during pregnancy

Primary outcomes:
measure: recurrent venous thromboembolism
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT03398759: Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery
Official title: Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery：a Randomized Control Double Blinded Clinical Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Agitation
Keywords: Butorphanol
Functional endoscopic sinus surgery
Emergence agitation
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Emergence agitation is one of the common postoperative complications after functional endoscopic sinus surgery（FESS). The objective of present study is to explore the effectiveness of butorphanol in the alleviation of emergence agitation in patients undergoing Functional Endoscopic Sinus Surgery.

Detailed description: Butorphanol is a mixed agonist-antagonist opioid with strong κappa-receptor agonist and weak mu-receptor antagonist activity. It is commonly used for the management of cancer, postoperative, gynecologic, and obstetric pain. Additionally, Butorphanol has less respiratory depression and sedation effects, which make it may become a good medicine to alleviate the agitation. However, there is no clinical evidence to confirmation of such effectiveness of butorphanol. The objective of present study is to explore the effectiveness of butorphanol in the alleviation of emergence agitation in patients undergoing Functional Endoscopic Sinus Surgery.

Eligibility criteria: Inclusion Criteria:

1. Age \>=18 years,\<=65years;
2. height 150-180 cm;
3. weight 55-80 kg;
4. Signed the inform consent
5. American Society of Anesthesiologists classification I to II
6. Select to functional endoscopic sinus surgery

Exclusion Criteria:

1. Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;
2. Several audition or vision disorder;
3. Unwillingness to comply with the protocol or procedures.
4. Can not communicated with Chinese Mandarin
5. Existing bradycardiac arrhythmia（Heart rate \<60 bpm for any reasons）
6. Existing gastrointestinal ulcer
7. Existing urinary incontinence
8. Existing asthma or chronic obstructive pulmonary disease
9. Allegory to Butorphanol

Primary outcomes:
measure: Emergence agitation incidence
timeFrame: 1 hour in the post anesthesia care unite(PACU)
Secondary outcomes:
measure: MAP
timeFrame: 1 hour in the post anesthesia care unite(PACU)
measure: HR
timeFrame: 1 hour in the post anesthesia care unite(PACU)
measure: quality of recovery -40 questionnaire
timeFrame: 24h after operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao Tong University, School of Medicine
state: Shanghai
Study officials:
affiliation: Anesthesiology Department Renji Hospital, Shanghai
name: Weifeng Yu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01714570: Piperacillin/Tazobactam for Empirical Therapy of Febrile Neutropenia
Official title: A Prospective, Randomized, Open Label Study of Piperacillin/Tazobactam Versus Imipenem/Cilastin for Empirical Therapy of Febrile Patients With Neutropenia After Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Febrile
Neutropenia
Hematopoietic Stem Cell Transplantation
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2012-10-26
Enrollment: 123
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neutropenia is very common in patients received hematopoietic stem cell transplantation, with median duration of about 14 days. In 2010 update, IDSA recommended Piperacillin/tazobactam as first-line mono-therapy for febrile patients with neutropenia of high risk. In china, the data of piperacillin/tazobactam for febrile neutropenia after hematopoietic stem cell transplantation is very limited.

The current study will evaluate the efficacy of piperacillin/tazobactam compared with imipenem/cilastatin for febrile neutropenia after transplantation.

Detailed description: 1. Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room after transplantation.
2. Randomize the febrile patients into 2 groups.
3. Therapy group receive piperacillin/tazobactam, 4.5g q6h iv. Control group receive imipenem/cilastatin, 0.5g q6h. Duration will be 5-10 days.

Eligibility criteria: Inclusion Criteria:

* Age 13-65 years
* received Autologous or Allogeneic hematopoietic stem cell transplantation.
* ECOG score 0-1.
* ICF is available.

Exclusion Criteria:

* Allergic to any therapy drug.
* Documented infection before neutropenia.
* Renal dysfunction.
* Suffering from central nervous system or mental disease.

Primary outcomes:
measure: Clinical success rate.
timeFrame: 3 weeks after beginning of empirical therapy
Secondary outcomes:
measure: Microbiologic success rate
timeFrame: 3 weeks after beginning of empirical therapy
measure: Adverse effect
timeFrame: 3 weeks after beginning of empirical therapy
measure: Cost of drug and therapy
timeFrame: 3 weeks after beginning of empirical therapy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA general hospital
state: Beijing
Study officials:
affiliation: Employee
name: wenrong huang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: