louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06947655: Impact of Different Perioperative Tourniquets on Blood Loss and Surgeon Satisfaction in Total Knee Arthroplasty
Official title: Impact of Two Different Perioperative Tourniquets on Blood Loss, Surgical Field and Surgeon Satisfaction During Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Knee Arthroplasty
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The present study investigates the impact of two different perioperative tourniquets with different closing features on operative blood los, surgical field quality and surgeon satisfaction.


Eligibility criteria: Inclusion Criteria:

* Inidication for a Total Knee Arthroplasty
* Approval for Surgery by the Department of Anesthesia

Exclusion Criteria:

* Open Wounds of the lower extremities
* Acute or chronic infections of the lower extremities

Primary outcomes:
measure: Blood Loss
timeFrame: Perioperative
measure: Surgeon Satisfaction
timeFrame: Perioperative
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn
state: NRW
Study officials:
References:
Clinical trial NCT01105455: The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Pregnant Women at Risk for Gestational Diabetes
Official title: The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Pregnant Women at Risk for Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes, Gestational
Keywords: Randomized clinical trial
Gestational diabetes
Carbohydrates
Glycemic index
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2010-04-16
Enrollment: 103
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Gestational diabetes mellitus (GDM) is a condition in which high blood sugar levels occur during pregnancy. GDM increases the risk of medical complications during pregnancy which may harm the mother and her baby. Since treating GDM to reduce blood sugar reduces the risk of harm, all pregnant women are screened for GDM using a glucose challenge test (GCT). We think that a diet containing low glycemic index foods could help keep blood sugar levels normal during pregnancy and therefore prevent GDM. Thus, the purpose of this study is to see if a diet containing low glycemic index foods will reduced blood sugar after the GCT and reduce the prevalence of GDM in women at high risk for the development of GDM.


Eligibility criteria: Inclusion Criteria:

* Attending Mt. Sinai Maternal Fetal Medicine Unit
* Any ONE of: body mass index \>=25 kg/m\^2
* OR age \>=35 years
* OR high risk ethnicity (Asian, South Asian, Hispanic, African, Aboriginal)

Exclusion Criteria:

* Have pre-existing diabetes (type 1 or type 2) before becoming pregnant
* Acute or chronic illness which may affect carbohydrate metabolism
* Language/literacy barriers which cannot be overcome via available resources
* \>16 weeks gestation

Primary outcomes:
measure: Serum glucose concentration 1hr after glucose challenge test
timeFrame: 26 weeks gestation
Secondary outcomes:
measure: GCT outcome
timeFrame: 26 weeks gestation
measure: GDM outcome
timeFrame: 26 weeks gestation
measure: Maternal weight
timeFrame: At EACH of the following times: 12, 16, 20, 24, 28, 32, 36 and 40 weeks gestation
measure: Mode of delivery
timeFrame: At time of birth of baby
measure: Presence of birth trauma
timeFrame: At time of birth of baby
measure: Weight of baby
timeFrame: At time of birth of baby
measure: Presence of macrosomia
timeFrame: At time of birth of baby
measure: presence of large for gestational age baby
timeFrame: At time of birth of baby
measure: Presence of small for gestational age baby
timeFrame: At time of birth of baby
measure: food frequency questionnaire
timeFrame: at 12 weeks and 26 weeks gestation
measure: Acceptability of study foods
timeFrame: 26 weeks gestation
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mt Sinai Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: Thomas MS Wolever, BM, BCh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00510055: Treatment of Acne Scarring With a Novel Procedure Combination
Official title: The Effect of Subcision and Calcium Hydroxylapatite (Radiesse) Injection on Rolling Acne Scarring Appearance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Scarring
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2007-08-01
Enrollment: 30
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: The primary objective of this study is to look at the efficacy of subdermal manipulation and filler injection in the improvement of acne scar appearance.

Detailed description: The primary objective of this study is to determine whether the use of subcision in conjunction with calcium hydroxylapatite injections will improve the appearance of rolling acne scars better than subcision alone.

Eligibility criteria: Inclusion Criteria:

* Age 18 and over
* Have two acne scar areas
* The subjects are in good health
* The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

Exclusion Criteria:

* Under 18 years of age
* Pregnancy or Lactation
* Subjects who are unable to understand the protocol or to give informed consent
* Subjects with mental illness

Primary outcomes:
measure: Scar Improvement
timeFrame: 3.5 months
Secondary outcomes:
measure: Adverse Events
timeFrame: 3.5 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06965855: Effect of Piezoelectric Surgery onPostoperative Complications in Third Molar Surgery
Official title: Revolution or Routine? Assessing the Postoperative Impact of Piezoelectric Surgery on Edema, Trismus, and Other Complications in Third Molar Extractions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Complication
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of piezoelectric surgery on postoperative edema, trismus and other postoperative complications (Wound Healing, Bleeding, Infection, Alveolitis, Paresthesia) with conventional bur method applied in surgical extraction of impacted mandibular third molars.

The main question it aims to answer is:

Is piezoelectric surgery effective on reducing the edema, trismus and other postoperative complications (Wound Healing, Bleeding, Infection, Alveolitis, Paresthesia) in impacted third molar surgery? Postoperative edema measurements are determined at 24 hours, 48 hours, and 7 days using the flexible ruler method. Trismus is determined by measuring the interincisal distance. Statistical analyses are performed to compare the two surgical methods.


Eligibility criteria: Inclusion Criteria:

* Patients with mesioangular, distoangular, vertical or horizontal, fully impacted and fully bone retained impacted lower wisdom teeth
* Patients without any systemic disease
* Patients who have been informed about the duration, purpose and requirements of the study and who have signed the informed consent form voluntarily.

Exclusion Criteria:

* Patients with any systemic contraindication, infection in the area of the tooth to be extracted, anamnesis of sensitivity to paracetamol derivatives or aspirin, pregnant or breastfeeding patients, and patients using antibiotics or anti-inflammatory drugs in the last 3 weeks
* In addition, smokers or alcohol addicts were not included in the study.

Primary outcomes:
measure: Edema amounts with Routine and Piezoelectric Surgery
timeFrame: The edema measurements are made on the patient preoperatively and on the 2nd and 7th postoperative days.
measure: Trismus amounts with Routine and Piezoelectric Surgery
timeFrame: The trismus measurements are made on the patient preoperatively and on the 2nd and 7th postoperative days.
Secondary outcomes:
measure: Wound healing, bleeding, infection, alveolitis, paresthesia, and temporomandibular joint pain with Routine and Piezoelectric Surgery
timeFrame: within 7 days after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Ege University
name: Mert Zeytinoğlu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06896955: Effects of Virtual Reality Application and Progressive Relaxation Exercise
Official title: Effects of Virtual Reality Application and Progressive Relaxation Exercise Training on Pregnant Women's Stress, Birth Affect and Birth Self-Efficacy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pregnancy
Exercise
Virtual Reality
Keywords: Pregnancy
Exercise
progressive exercise
virtual reality
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In the study, random assignment and randomization concealment will be applied to control selection bias. Pregnant women were assigned to groups by an independent statistician using the block randomization method. For this purpose, 6-digit combinations consisting of the letters "A", "B" and "C" were first created in the randomization of 78 women.

Detailed description: There will be three groups in the randomized experimental controlled study:PRE (Progressive Relaxation Exercise), VR (Virtual Reality)+PGR (Progressive Relaxation Exercise) and Control group. In order to carry out the application phase of the study, the responsible researcher participated in the training program on PRE and received a certificate on this subject. In addition, permission for the use of PRE Cd was obtained from the Turkish Psychologists Association to be used in the PRE group. The following procedures will be performed for pregnant women included in the study.

Eligibility criteria: Inclusion Criteria:

* Voluntary participation
* No communication difficulties (no mental retardation, no visual/hearing impairment)
* Knowing Turkish and being literate
* No fetal anomalies
* Being in the 32nd week of pregnancy
* Not being diagnosed with a risky pregnancy (multiple pregnancy, premature rupture of membranes, preeclampsia, gestational diabetes, placenta previa, etc., pregnancies may end with a cesarean section)

Exclusion Criteria:

* Having a psychiatric disease diagnosis

Primary outcomes:
measure: Pregnancy Stress Assessment Scale
timeFrame: pre-intervention, after 2 month
measure: Birth Self-Efficacy Scale
timeFrame: intervention after 2 month
measure: Birth Affect Scale
timeFrame: intervention after 2 month
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
Study officials:
affiliation: Cukurova University
name: Senay Dagilgan, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01602055: A Bioequivalence Study of Two Azithromycin Tablet Formulations in Indonesian Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fasting
Lead sponsor: PT Novell Pharmaceutical Laboratories
Sponsor class: INDUSTRY
First posted: 2012-05-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The aim of this study is to assess the bioequivalence of 500 mg Azithromycin FC tablets (Azivol) produced by PT. Novell Pharmaceutical Laboratories, compared to the reference product Zithromax 500 mg FC tablet produced by Pfizer Australia Pty, Ltd


Eligibility criteria: Inclusion Criteria:

* Healthy subjects, both sexes, age between 18 to 55 years old
* Weight with normal range according to accepted normal values for BMI (18-25 kg/m2)
* Give a written informed consent
* Acceptable medical history and physical examination
* Normal hematology values including hemoglobin, hematocrit, WBC, platelets, WBC differential
* Normal laboratory test including : Blood urea nitrogen, sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, fasting glucose, albumin and creatinine
* Normal urinalysis results including: specific gravity, color, pH, sugar, albumin, bilirubin, RBC, WBC and casts
* Acceptable electrocardiogram (ECG) result
* Negative result for serological tests of Hepatitis B, Hepatitis C and HIV
* Negative result for pregnancy test

Exclusion Criteria:

* Smoker or alcoholism
* Pregnant woman or nursing mother
* Have history of hepatic, cardiovascular, gastrointestinal or renal disease
* Potentially sensitive to azithromycin or other related drugs
* Received any investigation drug within four weeks
* Donation or loss more than 450 mL of blood within 3 months prior to the screening

Primary outcomes:
measure: Plasma concentration of azithromycin until 120 h after oral administration of 500 mg Azithromycin tablet (ng/mL)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: PT Clinisindo Laboratories
Study officials:
affiliation: Indonesia University
name: Yahdiana Harahap, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03570255: Feasibility and Performance Evaluation for INVSENSOR00024
Official title: Feasibility and Performance Evaluation of INVSENSOR00024
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaluation of SpO2 Performance
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2018-06-26
Enrollment: 28
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the RD SET Neo investigational pulse oximeter sensors in the neonatal population using convenience sampling in a clinical environment. The initial subjects under Protocol Version 1 were enrolled as part of a feasibility study to verify the design changes to the sensor are correct. The study protocol was amended with Protocol Version 2 to enroll a group of subjects that will be used to evaluate clinical performance for submission to regulatory agencies.


Eligibility criteria: Inclusion Criteria:

* Less than or equal to 1 month of age
* Weight \<3kg
* Subjects admitted with standard of care (SOC) arterial blood sampling line already in place

Exclusion Criteria:

* Subjects with underdeveloped skin
* Subjects with abnormalities at the planned application sites that would interfere with system measurements
* Subjects with known allergic reactions to foam/rubber products and adhesive tape
* Deformities of limbs, absence of feet, sever edema, and other at the discretion of the Principal Investigator

Primary outcomes:
measure: Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation
timeFrame: up to 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
References:
Clinical trial NCT06813014: Pharmacogenetics of Response to Sitagliptin (PRS)
Official title: Sitagliptin&#39;s Effects on Glucose-stimulated Insulin Secretion and Oral Glucose
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Diabetes
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 400
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: This is a research study to find out how different people respond to a medication called sitagliptin. Sitagliptin is an FDA approved medication that is used to treat diabetes. We are asking for healthy, non-diabetic volunteers to participate in this 7-week study. If you agree to participate, you will take part in 2 clinic visits that are 4-6 weeks apart. At the clinic visits you will have an oral glucose tolerance test (OGTT) and other blood tests to see how your body processes glucose (sugar). An OGTT is a test in which your drink glucose and then blood samples are taken afterward at specific time points to measure glucose and insulin in your blood. Each clinic visit will last about 5 hours.


Eligibility criteria: Inclusion Criteria:

* • Age: \&gt;18 years old

  * Members of Old Order Amish community in Lancaster, PA

Exclusion Criteria:

* • Pregnancy (reproductive age women will undergo pregnancy tests immediately before receiving the drug)

  * Diabetes: HbA1c \&gt; 6.5% or fasting plasma glucose \&gt;126 mg/dL
  * Estimated glomerular filtration rates (eGFR) \&lt;60 mL/min/1.73 m2
  * Anemia: hematocrit \&lt; 35%
  * Thyroid status: TSH\&lt;0.4 or TSH\&gt;5.5
  * ALT or AST in excess of 2X upper limit of normal
  * Drugs that in the physician's judgment would alter response to sitagliptin
  * Significant health issues that in the physician's judgment could increase the risk for participants.

Primary outcomes:
measure: Sitagliptin-induced enhancement of early insulin secretion
timeFrame: 6 weeks
measure: Sitagliptin-induced change in glucose tolerance
timeFrame: 6 weeks
Secondary outcomes:
measure: Area under the curve for insulin concentration
timeFrame: 6 weeks
measure: Area under the curve for glucose concentration
timeFrame: 6 weeks
measure: Area under the curve for intact GIP
timeFrame: 6 weeks
measure: Area under the curve for intact GLP1
timeFrame: 6 weeks
measure: Area under the curve for C-peptide levels
timeFrame: 6 weeks
Other outcomes:
measure: Parameters of a mathematical model (insulin secretion and glucose sensitivity of the β-cell
timeFrame: 6 weeks
Locations:
city: Lancaster
country: United States
facility: University of Maryland Amish Research Clinic
state: Pennsylvania
Study officials:
affiliation: University of Maryland, Baltimore
name: Amber L Beitelshees, PharmD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland, Baltimore
name: Simeon I Taylor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03959514: AT247, NovoRapid® and Fiasp® in Glucose Clamp Study
Official title: Phase I Single Dose, Randomised, Double-blind, Three-way Cross Over, Glucose Clamp Study Investigating the PK/PD and Safety of Arecor Ultra-rapid Insulin Aspart (AT247) in Comparison to NovoRapid® and Fiasp® in Participants With Type I Diabetes Mellitus (T1DM).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Arecor Limited
Sponsor class: INDUSTRY
First posted: 2019-05-22
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Phase I, randomised, single-centre, double-blind, single-dose, three period, balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT247, NovoRapid® and Fiasp® in male participants with type I diabetes mellitus.


Eligibility criteria: Inclusion Criteria include:

1. Diagnosis type I Diabetes Mellitus for at least 12 months
2. Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months
3. Fasting C-peptide concentration ≤8.5% (≤69 mmol/mol) at screening
4. BMI 18.5-35.0 kg/m2

Exclusion Criteria include:

1. known or suspected hypersensitivity to Investigational Medicinal Products
2. clinically significant concomitant disease or abnormal lab values
3. supine systolic BP outside range 95-140 mmHg and/or diastolic BP greater than 90 mmHg

Primary outcomes:
measure: Area under the glucose infusion rate-time curve of insulin aspart
timeFrame: 0-60 minutes
Secondary outcomes:
measure: Area under the serum insulin aspart concentration-time curve from 0-60 minutes
timeFrame: 0-60 minutes
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Clinical Research Centre
Study officials:
References:
citation: Svehlikova E, Mursic I, Augustin T, Magnes C, Gerring D, Jezek J, Schwarzenbacher D, Ratzer M, Wolf M, Howell S, Zakrzewski L, Urschitz M, Tschapeller B, Gatschelhofer C, Feichtner F, Lawrence F, Pieber TR. Pharmacokinetics and Pharmacodynamics of Three Different Formulations of Insulin Aspart: A Randomized, Double-Blind, Crossover Study in Men With Type 1 Diabetes. Diabetes Care. 2021 Feb;44(2):448-455. doi: 10.2337/dc20-1017. Epub 2020 Dec 16.