louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02083198: Effects of IV Chloride Content on Outcomes
Official title: A Comparison of High and Low Chloride Containing IV Fluid Solutions in Patients Undergoing Major Surgery and/or ICU Admission
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SIRS
Balanced Fluids
Plasmalyte
Keywords: hyperchloremic acidosis
balanced fluids
plasmalyte
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2014-03-11
Enrollment: 1558
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients with SIRS needing fluid replacement

Brief summary: This observational study evaluates the impact of high and low chloride containing IV fluids on administrative and clinical outcomes. The study uses a large electronic health dataset and examines patients receiving fluid replacement and resuscitation. The hypothesis is that high chloride solutions are associated with adverse outcomes as measured by administrative data and by clinical parameters.


Eligibility criteria: Inclusion Criteria:

* Adults meeting SIRS criteria receiving at least 500 mL of fluid replacement on day of SIRS.

Exclusion Criteria:

* Receipt of starches or other colloids

Primary outcomes:
measure: Mortality
timeFrame: Hospitalization, Expected Length of inpatient stay is approximately 7 days
Secondary outcomes:
measure: Length of Stay
timeFrame: inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days
measure: Acute renal failure
timeFrame: inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days
measure: Infections
timeFrame: inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days
measure: dysrhythmias
timeFrame: inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days
measure: Electrolyte disorders
timeFrame: inpatient hospitalizationExpected Length of inpatient stay is approximately 7 days
Other outcomes:
measure: readmission
timeFrame: 30, 60 and 90 day
Locations:
city: Deerfield
country: United States
facility: Baxter Healthcare
state: Illinois
Study officials:
References:
citation: Shaw AD, Schermer CR, Lobo DN, Munson SH, Khangulov V, Hayashida DK, Kellum JA. Impact of intravenous fluid composition on outcomes in patients with systemic inflammatory response syndrome. Crit Care. 2015 Sep 12;19(1):334. doi: 10.1186/s13054-015-1045-z.
Clinical trial NCT05958498: Consequence of Injectable Platelets Rich Fibrin Versus Microosteopeforation on Root Resorption During Orthodontic Intrusion of Incisor Teeth
Official title: Consequence of Injectable Platelets Rich Fibrin Versus Microosteopeforationon Root Resorption During Orthodontic Intrusion of Incisor Teeth: A Comparative Clinical Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Compare the Effect of Injectable Platelets Rich Fibrin and Micro-osteoperforations on Root Resorption During Orthodontic Intrusion of Incisors
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 18
Sex: ALL
Minimum age (years): 15
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Consequence of injectable platelets rich fibrin versus microosteopeforation on root resorption during orthodontic intrusion of incisor teeth

Detailed description: Consequence of injectable platelets rich fibrin versus microosteopeforation on root resorption during orthodontic intrusion of incisor teeth: A comparative clinical study

Eligibility criteria: Inclusion Criteria:

* 1. Patients with age range between 12-16 years. 2. Overbite \> 40% indicated for maxillary intrusion. 3. Mild to moderate crowding of upper incisors. 4. All permanent teeth erupted (excluding 3rd molars). 5. No previous orthodontic treatment. 6. Good oral hygiene with no previous periodontal surgery.

Exclusion Criteria:

1. - Transverse and/or vertical skeletal dysplasia or craniofacial malformation. 2. Retained primary or missing permanent teeth in the maxillary anterior area, and any kind of tooth/root shape anomaly.

3. Patients with root resorption, impacted canines, or dental anomalies. 4. Poor oral hygiene 5. Present or history of periodontal diseases. 6. Systemic diseases or regular use of medications that could interfere with orthodontic tooth movement.

7. History of trauma affecting the maxillary incisors. 8. Endodontically treated upper anterior teeth.

Primary outcomes:
measure: to compare the effect of injectable platelets rich fibrin and micro-osteoperforations on root resorption during orthodontic intrusion of incisors.
timeFrame: post interventionalal at 6months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AlAzhar university
Study officials:
References:
citation: Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Three-dimensional evaluation of the effects of injectable platelet rich fibrin (i-PRF) on alveolar bone and root length during orthodontic treatment: a randomized split mouth trial. BMC Oral Health. 2021 Mar 2;21(1):92. doi: 10.1186/s12903-021-01456-9.
citation: Dos Santos CCO, Mecenas P, de Castro Aragon MLS, Normando D. Effects of micro-osteoperforations performed with Propel system on tooth movement, pain/quality of life, anchorage loss, and root resorption: a systematic review and meta-analysis. Prog Orthod. 2020 Jul 27;21(1):27. doi: 10.1186/s40510-020-00326-4.
Clinical trial NCT03032198: "Clinical Evaluation of Opto-Acoustic Tomography for Detection and Diagnostic Differentiation of Thyroid Nodules"
Official title: "Early R&D Clinical Evaluation of Opto-Acoustic Tomography for Detection and Diagnostic Differentiation of Thyroid Nodules"
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Feasibility Study for Thyroid Indication
Lead sponsor: Seno Medical Instruments Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-26
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Thyroid Feasibility Study

Detailed description: This is an early R\&D Feasibility study to assess Imagio OA/US's ability to optimize the device algorithm specific to thyroid in order to detect the difference between benign and malignant thyroid nodules

Eligibility criteria: Inclusion Criteria:

1. Have been informed of the nature of the study and provided written informed consent, prior to initiation of any study activities;
2. Have an undiagnosed suspicious solid or mostly solid thyroid nodule.;
3. 18 years of age or older at the time of consent;
4. Are willing and able to complete all procedures and assessments in accordance with the clinical protocol; and,
5. Have received recommendation for and are scheduled for an ultrasound guided FNAB, ultrasound guided core biopsy, excisional biopsy, lobectomy or complete thyroidectomy of at least one thyroid nodule.

Exclusion Criteria:

1. Are prisoners;
2. Have a condition or impediment (i.e., insect bites, poison ivy, open sores, chafing of the skin, scar, tattoos, moles, etc.); that could interfere with the intended field of view (within one probe length or 4 cm of the nodule),
3. Previous or on-going radioactive iodine treatment.
4. Nodule to be biopsied is greater than 3.0 cm in maximum diameter;
5. Is pregnant;
6. Have an acute or a chronic hematoma and/or acute ecchymosis of the thyroid;
7. Is experiencing photo-toxicity or photo-sensitivity or is undergoing treatment for a photo-sensitive condition such as porphyria or lupus erythematosus;
8. Patient has received chemotherapy for any type of cancer within 90 days from date of screening CDU;
9. Have had previous image guided FNAB or surgical biopsy of the target nodule of interest within the 45 days of baseline Imagio Scan;
10. Patient has participated in a clinical study of an investigational drug or device within 3 months prior to screening CDU that may have an impact on clinical outcomes; and,
11. Patient has previously participated in this study.

Primary outcomes:
measure: Initial Assessment of Imagio's Ability to Distinguish Between Benign and Malignant Thyroid Nodules.
timeFrame: 12-24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Greenwood Village
country: United States
facility: Invision Sally Jobe
state: Colorado
city: San Antonio
country: United States
facility: UT Health Science Center
state: Texas
Study officials:
affiliation: Seno Medical, Inc.
name: Tom Stavros, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03086798: Comparison of Different Tools to Facilitate Nasotracheal Tube Placement Under Video-laryngoscope Use
Official title: Comparison Techniques of Magill Forceps and Cuff Inflation to Facilitate Nasotracheal Tube Placement Under Video-laryngoscope Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasotracheal Intubation
Keywords: Magill forceps
cuff inflation
Nasotracheal Intubation
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to investigate the effectiveness of techniques of either using Magill forceps or cuff inflation in facilitation of nasotracheal tube advancement into trachea

Detailed description: Patients who undergo oxo-maxillofacial surgery need naso-tracheal intubation to present good surgical view-field. but, sometimes, the naso-tracheal tube is unable to advance from nasopharynx, oropharynx, into trachea without assistance. Using techniques of either Magill forceps or cuff inflation is advantageous is not determined.

Eligibility criteria: Inclusion Criteria:

1. patients with American Society of Anesthesiologists physical status I-III
2. aged 20-65 years
3. Requiring Nasotracheal Intubation under general anesthesia
4. unlimited mouth open
5. unlimited neck motion

Exclusion Criteria:

1. mouth open \< 3 cm
2. Ankylosing arthritis patients.
3. BMI≧35 kg/m2

Primary outcomes:
measure: the technique spending time in this time interval and first attempt successful rate
timeFrame: 10 minutes
Secondary outcomes:
measure: total intubation time taken
timeFrame: half an hour
measure: glottic injury and cuff damages during tube advanced
timeFrame: half an hour
measure: postoperative nasal bleeding, sore throat and hoarseness
timeFrame: 2 days
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Department of anesthesiology, Kaohsiung Medical University, Taiwan
name: Kuang I Cheng, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05634798: An Observational Study Based on Endometrial Cancer Risk Screening Model
Official title: An Observational Study Based on Endometrial Cancer Risk Screening Model
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Neoplasms
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects were women of childbearing age, perimenopause and postmenopausal who had undergone physical examination in Peking Union Medical College Hospital or were recruited by patients from gynecological clinics.

Brief summary: The goal of this observational study is to test the efficiency of our endometrial cancer risk screening calculator, and improve the endometrial cancer risk screening model to form a stable and reliable non-invasive auxiliary diagnostic tool with high sensitivity and specificity in healthy women.The main question it aims to answer is:

·the efficiency of our endometrial cancer risk screening calculator Participants will be collected demographic information, as well as ultrasound, blood routine test and other test results, which will be entered into the endometrial cancer risk screening calculator to obtain high-risk or low-risk prediction results.


Eligibility criteria: Inclusion Criteria:

1. Age: 18-70;
2. The annual update of questionnaire information required by the calculator can be completed, and the gynecological examination, gynecological B-ultrasound and blood test can be evaluated once a year, and the follow-up can be at least 1 year; The patient or family members can understand the research scheme and are willing to participate in the study, and provide e-book informed consent.

Exclusion Criteria:

1. Endometrial cancer or precancerous lesions have been diagnosed;
2. Previous or current malignant tumor, currently receiving radiotherapy and chemotherapy, endocrine, targeted and immunotherapy;
3. History of endometrial resection or total hysterectomy;
4. Pregnant or lactating women;
5. The patient or family member could not understand the conditions and objectives of this study.

Primary outcomes:
measure: Obtained endometrial pathological specimens due to any factors
timeFrame: 1 year
measure: No endometrial cancer or precancerous lesions
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Shu Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00533598: A Study to Determine the Effects of MK0557 in Obese Subjects (0557-006)(COMPLETED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-09-21
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effects of MK0557 on body weight in obese subjects.


Eligibility criteria: Inclusion Criteria:

* Men and women between 21 and 65 years of age, willing to avoid all prescription and nonprescription medicine to alter body weight for entire study

Exclusion Criteria:

* You are or plan to become pregnant
* You have smoked or used nicotine within 6 months of the study
* History of abusing alcohol and/or drugs
* History of a stroke, you have diabetes mellitus, you are taking medication for high blood pressure, you have had recent surgery, you have been involved in another study within 3 months of study, use of cholesterol or anti-seizure medication during the study
* Have participated in a weight loss program 3 months before the study or during the course of the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00527098: Optimal Fluid Resuscitation for Trauma Patients
Official title: Optimal Fluid Resuscitation for Trauma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Keywords: Trauma Resuscitation
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2007-09-10
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Trauma Patients

Brief summary: The purpose of this study is to determine if the overall fluid requirements for the first 24 hours after admission will be reduced with Hextend versus a standard of care crystalloid resuscitation fluid.

Detailed description: Following severe multi-system traumatic injury, the first 24 hours of standard resuscitation fluid will be either Hextend or crystalloid depending upon attending preference. No tests or interventions will be performed for research purposes.

Data will be collected prospectively from patient medical records and attending clinicians to monitor fluid requirements, hemodynamics and outcome.

Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 18 years old and less than 65 years old
* Admission with multi-system traumatic injury
* Admission to the intensive care unit

Exclusion Criteria:

* Less than 18 or greater than 65 years old
* Pregnant or lactating
* No fluid resuscitation

Primary outcomes:
measure: Mortality
timeFrame: From hospital arrival up to an average of 3.5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Ryder Trauma Center
state: Florida
Study officials:
affiliation: University of Miami
name: Kenneth G Proctor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Carl I Schulman, MD, MSPH
role: STUDY_DIRECTOR
References:
citation: Earle SA, de Moya MA, Zuccarelli JE, Norenberg MD, Proctor KG. Cerebrovascular resuscitation after polytrauma and fluid restriction. J Am Coll Surg. 2007 Feb;204(2):261-75. doi: 10.1016/j.jamcollsurg.2006.11.014.
citation: Crookes BA, Cohn SM, Bonet H, Burton EA, Nelson J, Majetschak M, Varon AJ, Linden JM, Proctor KG. Building a better fluid for emergency resuscitation of traumatic brain injury. J Trauma. 2004 Sep;57(3):547-54. doi: 10.1097/01.ta.0000135162.85859.4c.
citation: King DR, Cohn SM, Proctor KG. Changes in intracranial pressure, coagulation, and neurologic outcome after resuscitation from experimental traumatic brain injury with hetastarch. Surgery. 2004 Aug;136(2):355-63. doi: 10.1016/j.surg.2004.05.011.
citation: Kelly ME, Miller PR, Greenhaw JJ, Fabian TC, Proctor KG. Novel resuscitation strategy for pulmonary contusion after severe chest trauma. J Trauma. 2003 Jul;55(1):94-105. doi: 10.1097/01.TA.0000029042.37577.A6.
Clinical trial NCT00974298: Uncemented Total Elbow Arthroplasty Data Collection
Official title: Uncemented Total Elbow Arthroplasty Data Collection
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Total Elbow Arthroplasty
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2009-09-10
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who require total elbow arthroplasty.

Brief summary: The purpose of this study is to document the performance and clinical outcomes of uncemented total elbow replacements involving the press-fit technique performed at the Vanderbilt Hand Center. The press-fit use technique is often used because of complications with cement loosening.

Detailed description: The three parts of this study will be:

Retrospective Chart Review-

A chart review will be completed on all patients that have had an uncemented total elbow arthroplasty using the press-fit technique at Vanderbilt Hand \& Upper Extremity Center. The chart review will include:

* A historical data form
* An operative data form
* A radiographic assessment form

Questionnaire Mailing- We will mail prospective study patients a DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire to complete with a mailing letter explaining the request for this information. The DASH will be modified to ask patients regarding their pre-operative time as well.

Clinical Data Collection-

We will enroll patients who have already had/or will be having a uncemented total elbow arthroplasty using the press-fit technique. If the patient already has a file completed through the chart review we will not complete the historical data form, operative form, or previous radiograph assessments. If the patient does not have a file completed through the chart review the data collection will include:

* An Informed Consent Document
* A historical data form
* An operative data form
* A radiographic assessment form
* Patient-completed DASH questionnaire
* Elbow Assessment Form

Eligibility criteria: Inclusion Criteria:

* Any patient who has had a total elbow arthroplasty using a press-fit technique at the Vanderbilt Hand \& Upper Extremity Center

Exclusion Criteria:

* Patients less than 18 years old
* For chart review and post-operative enrollment the patients must have adequate radiographs.

Primary outcomes:
measure: Patient examination measurements and radiographic measurements will be used to determine the effects of an uncemented total elbow arthroplasty
timeFrame: Pre-operative to five year post-operative appointment
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Hand & Upper Extremity Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Donald Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01414998: Sensorimotor Replacement With Electronic and De-nicotinised Cigarettes
Official title: The Effect of Non-nicotine Sensorimotor Replacement on Withdrawal and Craving: Studies With Electronic and De-nicotinised Cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Withdrawal
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2011-08-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: There are currently two sensorimotor replacement products which may be of benefit in smoking cessation: de-nicotinised cigarettes (denics) and electronic cigarettes (ECs), and the purpose of this project is to investigate whether these replacements can help to alleviate tobacco withdrawal symptoms in smokers, during a period of abstinence. This project will be separated into two studies, following the same design and procedures.

Study 1 will seek to confirm the importance of sensorimotor cues by comparing the efficacy of a nicotine-free EC in alleviating withdrawal symptoms, to a behavioural distraction tool (e.g. stress ball) which provides no smoking-related cues.

Study 2 will investigate whether sensorimotor replacements which are more proximal to smoking (i.e. Denics), will be more effective in alleviating withdrawal symptoms than a replacement which only delivers some of the conditioned sensorimotor cues (i.e. ECs).

The investigators hypothesise that the EC will be more effective at reducing withdrawal symptoms compared to the stress ball in Study 1. In Study 2, it is hypothesised that the Denic will be more effective than the EC.


Eligibility criteria: Inclusion Criteria:

* 18 years or over
* Smokes at least 10 cigarettes per day
* Smokes first cigarette within 1 hour of waking

Exclusion Criteria:

* pregnant or breastfeeding
* acute psychiatric illness
* currently enrolled in other research projects
* current use of ECs or Denics

Primary outcomes:
measure: Urge to smoke at 10 minutes post product use
timeFrame: 10 minutes
Secondary outcomes:
measure: Tobacco withdrawal symptom ratings over 1 hour
timeFrame: 1 hour
measure: Tobacco withdrawal symptom ratings over one day
timeFrame: 1 day
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Tobacco Dependence Research Unit
Study officials:
affiliation: Queen Mary University of London
name: Dunja Przulj
role: PRINCIPAL_INVESTIGATOR
References: