louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04251676: Radiation Therapy in Uterine Cancer: Dosimetry Analysis, Clinical Implication, and Survival Analysis
Official title: Radiation Therapy in Uterine Cancer: Dosimetry Analysis, Clinical Implication, and Survival Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with uterine cancer (stage I - IV) treated in National Taiwan University Hospital, from January 2010 to September 2019.

Brief summary: We wish to study radiation therapy in uterine cancer, focusing on dosimetry analysis, clinical implication, and survival analysis.

Detailed description: We wish to study radiation therapy in uterine cancer, focusing on dosimetry analysis, clinical implication, and survival analysis.

Eligibility criteria: Inclusion Criteria:

* Women with uterine cancer (stage I - IV) treated in National Taiwan University Hospital, from January 2010 to September 2019.

Exclusion Criteria:

* Women with uterine cancer (stage I - IV) NOT treated in National Taiwan University Hospital, from January 2010 to September 2019.

Primary outcomes:
measure: Progression free survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Chen JL, Huang YS, Huang CY, Hsu CY, Lan KH, Cheng WF, Kuo SH. Impact of adjuvant radiotherapy on the survival of women with optimally resected stage III endometrial cancer in the era of modern radiotherapy: a retrospective study. Radiat Oncol. 2020 Apr 6;15(1):72. doi: 10.1186/s13014-020-01523-5.
Clinical trial NCT01814176: Measurement of Forces Applied Using a Macintosh Direct Laryngoscope Compared to GlideScope Video Laryngoscope
Official title: Measurement of Forces Applied Using a Macintosh Direct Laryngoscope Compared to GlideScope Video Laryngoscope in Patients With at Least One Difficult Intubation Risk Factor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderately Difficult to Intubate
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2013-03-19
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: During Anesthesia many patients require that a breathing be inserted into their windpipe. This is usually achieved using a direct laryngoscope, consisting of a retraction blade with a light near its end. When achieving a direct line-of-sight to the windpipe is difficult, more force is often applied, resulting in greater patient stress. A GlideScope video laryngoscope uses a camera and light source to see the windpipe. This enables the user to see objects that may not be in the direct line-of-sight. This likely results in less force being required, reducing patient stress. Because such stresses are often confounded by patient variables, we are comparing the forces required by the direct and video laryngoscopes on patients with at least one risk factor for difficulty, by directly measuring these with special sensors attached to the laryngoscope blades.


Eligibility criteria: Inclusion Criteria:

* age \> 18years
* elective surgery
* single lumen endotracheal intubation required
* signed informed consent
* one risk factor for a difficult laryngoscopy ( Mallampati score \>3, inter-incisor gap \< 3.5cm, thyromental distance \< 6.5cm, sternomental distance \< 12.5cm, reduced neck extension and flexion)

Exclusion Criteria:

* lack of patient consent
* anesthesiologist declines to consent
* contraindication to neuromuscular blockade
* ASA 4
* rapid sequence intubation
* previous failed intubation
* other method of intubation indicated eg fiberoptic intubation, awake tracheostomy
* symptomatic gastro-esophageal reflux
* cervical spine instability
* unstable hypertension and symptomatic coronary artery disease
* cerebrovascular disease or raised intracranial pressure
* oral/pharyngeal/laryngeal carcinoma
* loose teeth/poor dentition

Primary outcomes:
measure: Peak forces during intubation
timeFrame: Intraoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
References:
citation: Cordovani D, Russell T, Wee W, Suen A, Cooper RM. Measurement of forces applied using a Macintosh direct laryngoscope compared with a Glidescope video laryngoscope in patients with predictors of difficult laryngoscopy: A randomised controlled trial. Eur J Anaesthesiol. 2019 Mar;36(3):221-226. doi: 10.1097/EJA.0000000000000901.
Clinical trial NCT03136276: One Year Clinical Evaluation of IPS Empress CAD Versus Polished Celtra Duo Ceramic Laminate Veneers
Official title: One Year Clinical Evaluation of IPS Empress CAD Versus Polished Celtra Duo Ceramic Laminate Veneers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Discoloration
Tooth Fractures
Diastema
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: When restoring teeth with IPS Empress laminate veneers, fracture of restorations may occur. So, material with higher mechanical properties is required. Celtra Duo is a new material with glass ceramics infiltrated by 10% zirconia particles which increase the fracture resistance of the material.


Eligibility criteria: Inclusion Criteria:

All subjects are required to be:

1. From 18-50 years old, be able to read and sign the informed consent document.
2. Have no active periodontal or pulpal diseases, have teeth with good restorations
3. Psychologically and physically able to tolerate conventional dental procedures
4. Patients with teeth problems indicated for laminate veneer:

   1. Discoloration
   2. Fracture not involving more than 50% enamel loss
   3. Mild malposition
   4. Diastema
   5. Enamel fluorosis
   6. Stained or defective restorations
5. Able to return for follow-up examinations and evaluation

Exclusion Criteria:

1. Patient with post and core endodontically treated teeth
2. Patient with fractured teeth of more than 50% enamel loss
3. Patients with poor oral hygiene and motivation
4. Pregnant women's
5. Patients in the growth stage with partially erupted teeth
6. Psychiatric problems or unrealistic expectations
7. Lack of opposing dentition in the area of interest
8. Patients involved in contact sports
9. Teeth with deep discoloration

Primary outcomes:
measure: Fracture
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01573676: The Influence of Bariatric Surgery on Patients With Obstructive Sleep Apnea (OSA)
Official title: The Influence of Bariatric Surgery on Patients With Obstructive Sleep Apnea (OSA)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overweight
Obstructive Sleep Apnea
Keywords: bariatric surgery
sleep apnea
overweight
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-04-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: both males and females

Brief summary: Obesity is a very important risk-factor in obstructive sleep apnea (OSA) and other sleep breathing disorders in patients with extreme BMI.

Candidates for bariatric surgery have a high OSA prevalence, ranging from 60-83%. The characteristics of patients with sleep apnea that were evaluated for bariatric surgery and had a full overnight polysomnography (PSG) screening for OSA were described and it was found that a very high prevalence (77.2%) for OSA in all subjects evaluated, regardless of pre-operative risk for OSA. A post-bariatric surgery PSG was not a part of this study.

The investigators would like to demonstrate the impact of bariatric surgery on OSA as a function of time.


Eligibility criteria: Inclusion Criteria:

* All candidates for bariatric surgery over 18 yrs of age

Exclusion Criteria:

* Patients that underwent any OSA surgery in the past
* Patient had any bariatric surgery in the past
* Patients with COPD
* Patients with CHD
* Patients who have / had cancer that received chemotherapy or radiotherapy

Primary outcomes:
measure: Improvement in RDI after bariatric surgery
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00551876: Study Evaluating the Efficacy and Safety of Simvastatin Alone Compared With Simvastatin Plus Ezetimibe in Type 2 Diabetic Patients (0653-021)(COMPLETED)
Official title: A Randomized, Double-Blind, Parallel, Multicenter Study to Evaluate the Efficacy and Safety of Simvastatin Monotherapy Compared With Simvastatin Plus Ezetimibe (SCH 58235) in Type 2 Diabetic Patients Treated With Thiazolidinediones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-10-31
Enrollment: 214
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
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 determine if the addition of ezetimibe 10 mg daily to ongoing 20 mg simvastatin daily will reduce LDL Cholesterol to a greater extent than increasing the dose of simvastatin to 40 mg daily in Type 2 diabetics treated with Thiazolidinediones (TZD).


Eligibility criteria: Inclusion Criteria:

* Men or women age between 30 and 75 with Type 2 diabetes mellitus who are treated with pioglitazone or rosiglitazone
* Additionally, patients must have an LDL-C \>100 mg/dL at Visit 1 or prior to initiation of statin therapy

Exclusion Criteria:

* Patients taking sliding scale insulin, selected lipid lowering medications, oral anticoagulants and cyclical sex hormones
* Patients with heart disease, kidney disease, liver disease, uncontrolled high blood pressure, and insulin dependent diabetes

Primary outcomes:
measure: Percent change in fasting LDL-C from baseline to the average of the Week 6/Week 12 measurements
timeFrame: 6 & 12 Weeks
Secondary outcomes:
measure: Well tolerated in patients in Diabetic patients
timeFrame: 30 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Gaudiani LM, Lewin A, Meneghini L, Perevozskaya I, Plotkin D, Mitchel Y, Shah S. Efficacy and safety of ezetimibe co-administered with simvastatin in thiazolidinedione-treated type 2 diabetic patients. Diabetes Obes Metab. 2005 Jan;7(1):88-97. doi: 10.1111/j.1463-1326.2004.00420.x.
Clinical trial NCT06369376: Electrodiagnostic Approach for Pectoral Nerve Conduction Studies
Official title: A New Electrodiagnostic Approach for Pectoral Nerve Conduction Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: New Nerve Conduction Protocol for Pectoral Nerve
Keywords: pectoral nerve
nerve conduction study
electromyography
electrodiagnostic
normative data
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 25
Sex: ALL
Minimum age (years): 22
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Anatomical studies have challenged traditional perceptions of the pectoral nerve structure, revealing a network of three branches rather than the previously accepted medial and lateral branches. This study aims to explore the implications of this updated anatomy on nerve conduction studies of the pectoral nerve and proposes a modified nerve conduction study protocol to enhance diagnostic accuracy.

A study on 25 volunteers was conducted, examining the three parts of the pectoral nerve. Electrode placement followed a detailed methodology ensuring precise data collection. The nerve conduction study was performed bilaterally, exploring latency and amplitude while addressing inter-observer variability and demographic influences.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* pregnancy
* Pectoral nerve injury in the pas
* Diabetes

Primary outcomes:
measure: Latency
timeFrame: 30 min
measure: Amplitude
timeFrame: 30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
Study officials:
affiliation: UZ Gent
name: Tina Decorte, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05330676: Evaluation of Microcirculatory Function and Mitochondrial Respiration After Cardiovascular Surgery
Official title: The MicroRESUS Study: An Observational Study to Examine the Effects of Circulatory Shock and Resuscitation on Microcirculatory Function and Mitochondrial Respiration After Cardiovascular Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shock
Cardiovascular Diseases
Critical Illness
Keywords: microcirculation
mitochondrial respiration
circulatory shock
cardiovascular surgery
resuscitation
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-04-15
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cardiovascular disease

Brief summary: This study will examine the differences in microcirculatory function and mitochondrial respiration in patients with shock after cardiovascular surgery.

Detailed description: Post-cardiotomy shock (PCS) occurs in up to 5% of cardiovascular surgeries and has an in-hospital mortality rate as high as 75%. It is unclear if patients with PCS despite achieving standard resuscitation goals have impairments in oxygen delivery or oxygen utilization. This study will examine the difference in microcirculatory function and mitochondrial respiration in patients with shock to better understand the driving mechanism of bioenergetic failure in patients with PCS.

Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18 years old)
* Receiving elective coronary artery bypass graft (CABG)
* Receiving valvular surgery requiring cardiopulmonary bypass

Exclusion Criteria:

* Unable to tolerate sublingual microcirculatory flow imaging (e.g., non-intubated patients dependent upon oxygen by facemask, poor mouth opening)
* receiving an emergent procedure
* have an actively treated malignancy
* mitochondrial disorder
* receiving surgery requiring deep hypothermic circulatory arrest.

Primary outcomes:
measure: Perfused Vessel Denisty (PVD)
timeFrame: PVD was measured at baseline (immediately prior to surgery), at ICU admission, approximately 4 hours after surgery, then at 24 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Perelman School of Medicine at the University of Pennsylvania
name: John C. Greenwood
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04830176: Role of Herbal Dentifrices in the Management of Plaque Induced Gingivitis
Official title: Role of Moringa Dentifirice in the Management of Plaque Induced Gingivitis. A Clinical Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingiva; Infection
Plaque, Dental
Keywords: miswak
moringa
plaque
gingival bleeding
Lead sponsor: Ajman University
Sponsor class: OTHER
Collaborators: name: A B Shetty Memorial Institute of Dental Science
First posted: 2021-04-05
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: sample size of 30- First group of 15 subjects recording of plaque and gingival scores were recorded. Patients were given first dentifrice and asked to brush for 72 hours and then asked to report. A washout period of 2 weeks followed. The next round, the subjects were given the second dentifrice and asked to brush for 72 hrs and then after a period of 3days asked to report
Primary purpose: PREVENTION

Brief summary: The clinical cross over study involves the use of two herbal based dentifirices moringa and miswak and its efficacy in reducing plaque induced gingivitis. The patients selected are provided with details regarding the research format and consent taken.

Detailed description: The clinical cross over study involves use of miswak and moringa dentifrices. The patients selected are 30 in no and are selected based on having gingival inflammation due to plaque accumulation. All other cases related to gingival inflammation along with patients with underlying systemic disease are excluded from the study.

At baseline, plaque and gingival scores are recorded, followed by giving one of the dentifrice to the patient for brushing. The patients are asked to brush twice a day and asked to report after 72 hrs, following which another recording of plaque and gingival scores are recorded.

The patients are then asked to use their own tooth paste for a period of 2 weeks as a wash out period and recalled after this 2 week interval.

The patients are then given the second dentifrice and asked to brush for 72 hrs and then asked to report again for a plaque and gingival score evaluation.

Eligibility criteria: Inclusion Criteria:

* subjects having only plaque induced gingival inflammation

Exclusion Criteria:

* Subjects having gingival inflammation related to underling systemic diseases
* Subjects taking medications
* Gingival inflammation related to other causes

Primary outcomes:
measure: plaque scores
timeFrame: 72 hours
Secondary outcomes:
measure: Gingival inflammation scores
timeFrame: 72 hours
Other outcomes:
Locations:
city: Mangaluru
country: India
facility: AB shetty Institute of dental sciences
Study officials:
References:
Clinical trial NCT02708576: Phase 1 Study of NGM313 in Healthy Adult Participants
Official title: A Phase 1 Randomized, Double Blind, Placebo Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NGM313 in Healthy Overweight and Obese Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: NGM Biopharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2016-03-15
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and tolerability of NGM313, both single dose and multiple doses, in normal healthy overweight and obese adult participants.


Eligibility criteria: Inclusion Criteria:

* BMI range 27-40 kg/m2, inclusive for the SAD module, and 27-40 kg/m2, inclusive for the MAD module;
* Normal clinical laboratory evaluations
* Normal ECG findings

Exclusion Criteria:

* Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
* Uncontrolled hypertension defined as sitting blood pressure systolic \> 150 mm/Hg and/or diastolic \> 90 mm/Hg

Primary outcomes:
measure: Absolute change in weight in kilograms
timeFrame: 28 and 84 days
Secondary outcomes:
measure: Absolute change in fasting glucose in mmol/L
timeFrame: 28 and 84 days
Other outcomes:
measure: Safety and tolerability as measured by adverse events, vitals signs, electrocardiograms, and clinical laboratories
timeFrame: 28 and 84 days
measure: Pharmacokinetics as measured by maximum observed concentration (cmax).
timeFrame: 28 and 84 days
measure: Pharmacokinetics as measured by time to maximum concentration (tmax).
timeFrame: 28 and 84 days
measure: Pharmacokinetics as measured by area under the curve (auc).
timeFrame: 28 and 84 days
Locations:
city: Melbourne
country: Australia
facility: NGM Clinical Study Site
state: Victoria
Study officials:
affiliation: NGM Biopharmaceuticals, Inc
name: Que Liu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03508076: Efficacy of Vibrating Capsule in Patients With Chronic Constipation
Official title: Efficacy of Vibrating Capsule in Patients With Chronic Constipation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Constipation
Keywords: Vibrating Capsule
Efficacy and Safety
Chronic Constipation
different vibrating modes
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Constipated patients in the participating center from February 2017 to June 2018 (anticipated) were prospectively enrolled. Number of defecation per week，Bristol score，and Colon transmission experiment were compared with the constipated patients before treatment.

Detailed description: Constipation affects the quality of life of patients, some patients abuse laxatives or repeated medical treatment, increased medical costs. At present, the main treatment of constipation is to adjust life style, medicine, psychotherapy, biofeedback and surgical treatment. However, the above methods are associated with adverse reactions, and the patient's satisfaction is still low. A new approach is needed to solve this clinical problem.

Investigators have developed a vibration capsule that can be adjusted in different modes.

Preliminary animal experiments showed that the capsule was safe and increased the number of defecation.

This study is a clinical research for patients with constipation, to explore the effect in different vibrating modes in patients with constipation and tract emptying transmission and its effectiveness.

Eligibility criteria: Inclusion Criteria:

* Adult patients aged form 18 to 80
* Clinical diagnosis of functional constipation
* Must be able to swallow vibrating capsule

Exclusion Criteria:

* complex history of gastrointestinal diverticula, obstruction, ulcer, bleeding, stenosis or fistula.
* recent use of banned drugs.
* patients who are preparing for mri.

Primary outcomes:
measure: defecation frequency
timeFrame: 8 weeks
Secondary outcomes:
measure: Bristol Stool Chart
timeFrame: 8 weeks
measure: first defecation
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
References:
citation: Yu J, Qian YY, He CH, Zhu SG, Zhao AJ, Zhu QQ, Shao CW, Wang TG, Wang Y, Ding GL, Liao Z, Li ZS. Safety and Efficacy of a New Smartphone-controlled Vibrating Capsule on Defecation in Beagles. Sci Rep. 2017 Jun 6;7(1):2841. doi: 10.1038/s41598-017-02844-4.