louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06185075: Influence of Implant Crown Transmucosal Contour Design on Soft and Hard Tissue Clinical Outcomes
Official title: Influence of Implant Crown Transmucosal Contour Design on Soft and Hard Tissue Clinical Outcomes
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Gum Disease
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate how the crown's shape under the gums will influence the gum tissue around dental implants.

Detailed description: This research is studying the transmucosal contour, or shape of crowns (white-colored tooth structure that sits above the gum) under the gums on dental implants. Participants will be randomly selected for the dental implant crown to be designed with either a straight or concave transmucosal contour, and followed up on for 1 year after crown delivery.

Eligibility criteria: Inclusion criteria

* Be a current participant of HUM00208140 main study
* Have a dental implant that is ready to be restored (placed at least 3 months ago and healing is adequate)

Exclusion Criteria:

• The dental implant crown was already delivered.

Primary outcomes:
measure: Marginal bone loss around dental implant
timeFrame: 6 months and 12 months after crown delivery
measure: Gum tissue thickness
timeFrame: 6 months and 12 months after crown delivery
measure: Gingival margin height
timeFrame: 6 months and 12 months after crown delivery
measure: Amount of keratinized gingiva
timeFrame: 6 months and 12 months after crown delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry
state: Michigan
Study officials:
affiliation: University of Michigan
name: Muhammad Saleh, BDS, MSD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02769559: Reduction Mammaplasty and Improved Quality of Life
Official title: Reduction Mammaplasty Safely Increases the Quality of Life in Patients With Mammary Hypetrophy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macromastia
Signs and Symptoms
Quality of Life
Lead sponsor: University Hospital Bratislava
Sponsor class: OTHER
Collaborators: name: Comenius University
First posted: 2016-05-11
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females with macromastia undergoing elective reduction surgery.

Brief summary: The data gathered here will be used to evaluate the efficacy and safety of the mammary reduction in patients with macromastia.

Detailed description: The data was gathered using retrospective and follow-up prospective study of a group of patients, consisting of adult women that underwent a breast reduction surgery at the Clinic of Plastic, Reconstructive and Aesthetic Surgery Faculty of Comenius University and at the University Hospital in Bratislava, Ružinov, during the time period between 2000 until May 2014. The data concerning the quality of life of these patients was gathered by using the globally standardized questionnaire "Breast Q questionnaire©" with the separate software system evaluation tool "QScore©". The statistical analysis was conducted using GraphpadPrism program v. 6.01. The total number of respondents consisted of 52 people who were followed-up for up to 12 years.

Eligibility criteria: Inclusion Criteria:

* above 18 years
* macromastia on clinical examination
* fulfilled Breast Q Questionnaire prior to surgery and after surgery
* signed informed consent

Exclusion Criteria:

* failed to sign informed consent
* failed to fill the Breast Q Questionnaire
* patients with altered mental status and behaviour
* patients with concomitant breast disease, or with previous breast interventions as are radiotherapy, surgery, or breast cancer

Primary outcomes:
measure: Quality of life
timeFrame: 2000-2014
Secondary outcomes:
measure: Rate of adverse outcomes
timeFrame: 2000-2014
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: University Hospital Bratislava
Study officials:
References:
Clinical trial NCT03855059: IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery
Official title: Double Blind Prospective Study of IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Lower Limb Injury
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind study
Primary purpose: SUPPORTIVE_CARE

Brief summary: IV and included steroids have produced the same length of block prolongation in adults as if the steroid was given with the nerve block. Clinically, this has not be noticed in children. The objective of this study is to examine this in young patients. The investigator will blindly give the steroid either in the IV or in the block solution (perineural). This is a prospective double blind study.

Detailed description: The subject has a 50/50 chance of receiving either cohort. After the subject is randomized to receive either steroid given IV or with the nerve block, the subject is anesthetized and the subject will receive either an IV injection of 5 cc steroids or placebo, and 20 cc local anesthetic plus placebo or steroid in the nerve block, the block will be placed under ultrasound to insure proper placement of block, the dose of steroid is based on weight, 0.1 - 0.15 mg/kg. The investigator will record the time of block and IV injection. The subjects will be called by the study PI after 24 hours to determine the time of duration and again at 48 hours if needed. This is a randomized, double blind study, neither the subject or the anesthesiologist giving the injection will know what is being given. The medications will be prepared and dispensed by the Research pharmacist, a randomization chart will be obtained by the research pharmacist.

Eligibility criteria: Inclusion Criteria:

* Scheduled to have a lower limb Orthopedic surgical procedure.
* Scheduled to have a nerve block placed for post operative analgesia.
* American Society of Anesthesiologist (ASA) Class I - III.

Exclusion Criteria:

* Not scheduled to have a nerve block placed for post operative analgesia.

Primary outcomes:
measure: Analgesia Duration
timeFrame: 24 - 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University Medical Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Peter R Lichtenthal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01646359: Value of Pulse Pressure Variations and Corrected Flow Time in Esophageal Doppler as a Predictor of Fluid Responsiveness in Prone Position During Spinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elective Posterior Lumbar Spinal Fusion
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In patients under mechanical ventilation, Usefulness of dynamic indices based on the heart-lung interactions for guiding volume resuscitation has been well validated. Recently, validity of pulse pressure variation (PPV) has been also reported to predict fluid responsiveness. Oesophageal Doppler (OED) allows continuous monitoring of several important hemodynamic variables. Of the OED variables, corrected flow time (FTc) has been evaluated and used as a preload index, and has been reported to predict fluid responsiveness. Prone position caused physiologic and hemodynamic changes and influenced the predictability and cut-off values of SVV and PPV for fluid responsiveness. In this prospective controlled study, the investigators evaluated the validity of PPV and FTc as predictors for fluid responsiveness in supine and prone position in patients undergoing posterior lumbar spinal fusion


Eligibility criteria: Inclusion Criteria:

* patients undergoing elective spine surgery
* age : \> 20 and \< 70, 3. Patients expecting intraoperative blood loss more than 10% of estimated blood volume

Exclusion Criteria:

* arrhythmias
* BMI \> 30 kg/m2
* valvular heart disease
* left ventricular ejection fraction \< 50%
* history of lung disease
* pregnancy
* foreigner
* contraindications to esophageal doppler monitoring probe insertion (i.e. oesophageal stent, carcinoma of the oesophagus or pharynx, previous oesophageal surgery, oesophageal stricture, oesophageal varices, pharyngeal pouch, intra-aortic balloon pump, coarctation of the aorta, and severe coagulopathy)

Primary outcomes:
measure: PPV(Pulse pressure variation)
timeFrame: 15 minutes after induction of anaesthesia at the supine position
measure: FTc(corrected flow time)
timeFrame: 15 minutes after induction of anaesthesia at the supine position
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine and Anesthesia
Study officials:
References:
citation: Yang SY, Shim JK, Song Y, Seo SJ, Kwak YL. Validation of pulse pressure variation and corrected flow time as predictors of fluid responsiveness in patients in the prone position. Br J Anaesth. 2013 May;110(5):713-20. doi: 10.1093/bja/aes475. Epub 2012 Dec 28.
Clinical trial NCT04987359: A Trial of a Multimodal Lifestyle Intervention to Optimize Survivorship After Cancer
Official title: A Randomized Trial of a Multimodal Lifestyle Intervention to Optimize Survivorship After Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neoplasm Malignant
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To examine the efficacy of a 10-week multimodal lifestyle program, versus waitlist control, on cardiorespiratory fitness capacity and body weight in survivors of cancer.


Eligibility criteria: Inclusion Criteria:

* Ability to provide informed consent before any trial-related activities
* History of any malignancy
* Completion of cancer-directed therapy (e.g., surgery, chemotherapy, and radiotherapy) prior to enrollment (patients receiving ongoing endocrine or targeted therapy are eligible to participate)
* No evidence of residual or recurrent cancer under active treatment
* Age ≥18 years
* Body mass index (BMI) ≥30 kg/m2 or BMI ≥27 kg/m2 with one or more treated or untreated weight-related coexisting conditions
* Willing to be randomized
* Allow the collection and storage of biospecimens and data for future use

Exclusion Criteria:

* Engaging in ≥3 purposeful exercise sessions per week, on average, over the past 12 weeks
* Significant purposeful weight loss (\>11 kg) within the past 12 weeks
* Current use of medications or devices for the purpose of weight loss
* Metabolic or bariatric surgery within the last year
* Cardiovascular, respiratory, or musculoskeletal disease that would prohibit participation in an exercise and weight loss program
* Currently pregnant, breastfeeding, or planning to become pregnant with the next 12 weeks
* Psychiatric disorders or conditions that would preclude participation in the study intervention
* Any other condition which, in the opinion of the investigator, may impede testing of the study hypothesis or make it unsafe to engage in the study

Primary outcomes:
measure: Change in cardiorespiratory fitness capacity (co-primary)
timeFrame: Baseline, Week 10
measure: Change in body weight (co-primary)
timeFrame: Baseline, Week 10
Secondary outcomes:
measure: Change in waist Circumference
timeFrame: Baseline, Week 10
measure: Change in fat Mass
timeFrame: Baseline, Week 10
measure: Change in systolic blood pressure
timeFrame: Baseline, Week 10
measure: Change in diastolic blood pressure
timeFrame: Baseline, Week 10
measure: Change in medication use
timeFrame: Baseline, Week 10
measure: Change in physical and mental quality-of-life
timeFrame: Baseline, Week 10
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Justin C Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01242059: Yellow Pea Fractions and Short-term Food Intake, Subjective Appetite and Glycemic Response
Official title: Effect of Yellow Pea Fractions on Short-term Food Intake at 120 Minutes, Subjective Appetite and Glycemic Response in Young Adult Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Type II Diabetes Mellitus
Metabolic Syndrome
Keywords: Obesity
Food intake regulation
blood glucose regulation
protein
fiber
pulses
yellow peas
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Agriculture and Agri-Food Canada
name: Pulse Canada
First posted: 2010-11-16
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: It is hypothesized that yellow pea protein and fiber will reduce short-term food intake, subjective appetite and glycemic response.

Detailed description: A within-subject, randomized study was conducted. Each subject returned 5 times, 1 week apart, and received 1 of the 5 treatments per week. The 5 treatments were tomato soup with 10 or 20 g of isolated yellow pea fibre or protein, or a control soup with no added pea fractions. Food intake was measured at an ad libitum pizza meal served 2 hours after treatment. Satiety and blood glucose (via finger prick) were measured throughout the treatment period.

Eligibility criteria: Inclusion Criteria:

* male 20-30 years old healthy weight

Exclusion Criteria:

* smoking restrictive eating metabolic diseases breakfast skippers dieters

Primary outcomes:
measure: Energy Intake
timeFrame: at 120 minutes after treatment
Secondary outcomes:
measure: Glycemic Response
timeFrame: 200 minutes
measure: Subjective Appetite
timeFrame: 200 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto - Department of Nutritional Sciences
state: Ontario
Study officials:
affiliation: University of Toronto
name: G Harvey Anderson, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01650259: Long-term Daily Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus
Official title: Post Marketing Surveillance on Long Term Drug Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2012-07-26
Enrollment: 4876
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 3300

Brief summary: Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as monotherapy in patients with type 2 diabetes mellitus and to assess baseline characteristics of patients with type 2 diabetes mellitus starting Trazenta® Tablets or any other oral antidiabetic monotherapy (naïve or switched from prior therapy of different oral antidiabetic drug).


Eligibility criteria: Inclusion criteria:

* Male and female patients with type 2 Diabetes Mellitus who have never been treated with Trazenta tablets / Linagliptin (monotherapy) before enrollment. (Trazenta group)
* Patients with type 2 Diabetes Mellitus starting any other oral antidiabetic monotherapy (naïve or switched from prior therapy of different oral antidiabetic drug (OAD)) except Trazenta tablets. (OAD group)

Exclusion criteria:

None

Primary outcomes:
measure: Percentage of Participants With Adverse Drug Reactions (ADRs)
timeFrame: From start of the treatment until the end of this PMS, i.e. up to week 156
Secondary outcomes:
measure: Change From Baseline in HbA1c at the Last Observation During the Observation Period.
timeFrame: Baseline and 156 week or last observation
Other outcomes:
Locations:
city: One Or Multiple Locations
country: Japan
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Yabe D, Yamamoto F, Lund SS, Okamura T, Kadowaki T. Long-term safety and effectiveness of linagliptin by baseline body mass index in Japanese patients with type 2 diabetes: a 3-year post-marketing surveillance study. Expert Opin Drug Saf. 2022 Oct;21(10):1303-1313. doi: 10.1080/14740338.2022.2057948. Epub 2022 May 3.
citation: Yamamoto F, Ikeda R, Ochiai K, Hirase T, Hayashi N, Okamura T. Long-Term Safety and Effectiveness of Linagliptin in Japanese Patients with Type 2 Diabetes and Renal Dysfunction: a Post-Marketing Surveillance Study. Diabetes Ther. 2020 Feb;11(2):523-533. doi: 10.1007/s13300-019-00754-4. Epub 2020 Jan 13.
citation: Yamamoto F, Unno Y, Okamura T, Ikeda R, Ochiai K, Hayashi N. Long-Term Safety and Effectiveness of Linagliptin in Japanese Patients with Type 2 Diabetes Mellitus: A 3-Year Post-Marketing Surveillance Study. Diabetes Ther. 2020 Jan;11(1):107-117. doi: 10.1007/s13300-019-00723-x. Epub 2019 Nov 11.
Clinical trial NCT01269970: Early Metabolic Response in Locally Advanced Esophageal Cancer Undergoing Induction Chemoradiotherapy
Official title: Early Metabolic Response Evaluation With 18-FDG PET-CT in Esophageal Cancer Treated With Neoadjuvant Chemoradiotherapy Followed by Esophagectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Carcinoma (Squamous Cell Carcinoma - Adenocarcinoma)
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-01-04
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: locally advanced esophageal cancer (cT2-4 N0/+) of the esophagus (n=42) and GEJ (n=13)

Brief summary: Early metabolic response evaluation may predict clinical and histopathological response after neoadjuvant chemotherapy. Its value in neoadjuvant chemoradiotherapy (CRT) is unknown. Our aim was to assess the value of early metabolic response after one cycle of chemotherapy using 18-FDG-PET-CT to predict pathological response and outcome in cT2-4 N0/+ esophageal cancer treated by neoadjuvant CRT and esophagectomy.


Eligibility criteria: Inclusion Criteria:

* locally advanced esophageal cancer (cT2-4 N0/+)

Exclusion Criteria:

* PET-CT not performed at UZLeuven
* Other tumor types
* Distant metastases (organ)

Primary outcomes:
measure: early metabolic response to predict pathological response and outcome
Secondary outcomes:
measure: to study correlations between early metabolic response, late metabolic response, histopathological response and outcome.
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
state: Vlaams-Brabant
Study officials:
References:
Clinical trial NCT01529970: Genetic Study in Young Onset Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2012-02-09
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients from China Medical University Hospital

Brief summary: Parkinson's disease (PD) is the second most frequent neurodegenerative disorder after Alzheimer's disease. It causes motor dysfunctions, such as bradykinesia, resting tremor, rigidity and postural instability. Although PD appears to be sporadic in most cases, several causative genes and susceptibility factors have been identified that cause familial forms of the disease with Mendelian inheritance with autosomal dominant or autosomal recessive inheritance.

Approximately 5\~10% of patients with the clinical picture of PD carry a mutation in one of the known genes that cause monogenic forms of the disorder. The average age at onset is between 60 and 80 years and the average age of diagnosis is 60 years. Onset of primary parkinsonism before 50 years is known as early onset parkinsonism(EOP). Onset between 20 and 50 years is known as young-onset PD. Onset at younger than 20 years is known as juvenile parkinsonism (JP). At least, 13 loci and 9 genes are reported. The investigators study is aimed to screen the clinical diagnosed familial EOP for the common mutation site by PCR/DNA sequencing. The gene for screen are Parkin (pattern: PARK2), PINK1 (pattern: PARK6) and ATP13A2 (pattern: PARK9).


Eligibility criteria: Inclusion Criteria:

* Idiopathic Parkinson's disease (according to UK Parkinson's Disease Society Brain Bank clinical diagnosis criteria)
* Onset before 50-year-old or positive family history

Exclusion Criteria:

* Secondary parkinsonism

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: